juno-pharmaceuticals

Juno - CPHI Conference 2024

dewantasinuzzaman@junopharma.com (Dewan Tasinuzzaman) — Thu, 29 Aug 2024 18:37:49 GMT

Juno - CPHI 2024

Juno Pharmaceuticals at CPHI Milan 2024!

We're excited to share that Juno Pharmaceuticals will be part of CPHI Milan 2024 – a notable event in the pharmaceutical industry calendar.

Connect with us to engage in discussions about upcoming projects, potential collaborations, and the exploration of fresh opportunities. Our team is here to share insights and explore the realms of innovation and sustainability in healthcare.

Reach out at business@junopharm.com to schedule a meeting with the Juno team at CPHI Milan.

Date: October 8th to October 10th

Location: Milan, Italy

Let's connect for a brighter healthcare future, together!

New Product Launch

dewantasinuzzaman@junopharma.com (Dewan Tasinuzzaman) — Wed, 21 Aug 2024 14:29:45 GMT

New Product Launch: Norepinephrine

Juno Pharmaceuticals Canada is pleased to announce the launch of our latest product, Norepinephrine Bitrate for injection which is available at your local Canadian wholesalers!

Norepinephrine is indicated for the restoration and maintenance of blood pressure in acute hypotensive or shock states ,such as surgery, trauma, hemorrhage myocardial infarction, pheochromocytomectomy, sympathectomy, spinal anesthesia, septicemia, drug reactions, poliomyelitis and blood transfusion reactions.

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New Product Launch

dewantasinuzzaman@junopharma.com (Dewan Tasinuzzaman) — Wed, 21 Aug 2024 14:27:17 GMT

New Product Launch: Eptifibatide

Juno Pharmaceuticals Canada is pleased to announce the launch of our latest product, Eptifibatide for injection which is available at your local Canadian wholesalers!

Eptifibatide is used for the treatment of patients presenting with symptoms of unstable angina (UA)/non-ST-segment

elevation myocardial infarction (NSTEMI), including those patients who may subsequently undergo

percutaneous coronary intervention (PCI) as well as those who will be managed medically.

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Quality & Compliance Specialist

dewantasinuzzaman@junopharma.com (Dewan Tasinuzzaman) — Thu, 11 Jan 2024 21:32:17 GMT

Quality & Compliance Specialist

POSITION SUMMARY

The Quality & Compliance Specialist jointly with the Manager, Quality is responsible for the quality assurance, quality control and quality compliance activities in support of the importation and distribution of JPC’s drug products. The candidate will support the Manager, Quality in leading the operational oversight, decision making and performance of activities relating to establishment licensing, batch record review, product dispositions, vendor qualification, self-inspections, complaints, deviations, CAPAs, SOP writing, change control, process validation, analytical method validation/transfer, department KPI management, and the fulfilment of post market commitments.

The Quality & Compliance Specialist must act as a positive influence toward quality awareness throughout the organization. The position requires detailed knowledge of Health Canada Food and Drugs Act, regulations and guidance documents. Experience in the quality and commercial requirements of sterile drug products used in a hospital setting for the provincial and territory health care programs in Canada is an asset. The successful candidate is detail oriented and is able to demonstrate problem solving skills to identify root causes, propose solution and drive excellence in continuous improvement. The role requires analytical thinking, evidence based decision making skills and exceptional time management abilities to progress multiple concurrent projects within established timelines.

KEY RESPONSIBILITIES AND PRIMARY DUTIES

• Support the digital transformation of the quality management system

• Create/write, revise, review and enforce Juno’s SOPs as needed to support operational activities.

• Lead the enhancement and maintenance of training materials to provide effective SOP and GMP training to Juno’s staff as needed.

• Develop strategies to achieve method transfers and validations at Juno’s local labs to facilitate product launches and confirmatory testing.

• Perform dispositions of drug products to the Canadian market ensuring compliance to Health Canada regulations and Juno’s SOPs.

• Review Annual Product Quality Review and Yearly Biologic Product Reviews generated by Juno’s quality assurance department and partners to ensure compliance to the marketing authorization.

• Document, report, investigate and respond to product complaints.

• Support the vendor qualification program by performing onsite, virtual and/or desk-based audits of JPC’s GMP service providers.

• Support the quality oversight of pharmaceutical manufacturing, packaging/labelling and testing deviations/non-conformance investigations and CAPA implementation at CMO’s and internally.

• Identify non-conformances, initiate investigations and lead the impact assessments to support process control and product dispositions.

• Lead the maintenance of JPC’s drug establishment licence foreign building annex, Table A and GMP evidence of foreign buildings.

• Perform quality assurance impact assessment for internal and third-party related change control records.

• Review JPC’s product labelling for regulatory compliance.

• Support in any regulatory or third party audit of JPC as required.

• Proactively monitor USP and BP for monograph updates and prepare for implementation

• Perform additional duties as assigned by the Manager, Quality.

QUALIFICATIONS / EDUCATIONAL REQUIREMENTS / SKILLS

• University degree (B.Sc. or higher) in Chemistry, Biology, Biochemistry or Health Sciences.

• Post-Graduate Certification in Regulatory Affairs and Quality Assurance preferred.

• Detailed knowledge of Canadian Food and Drugs Act and Regulations, Health Canada guidance documents, ICH guidance documents, GMPs and other relevant guideline with focus in sterile injectables used in a hospital setting.

• Minimum 5 years relevant Canadian experience in a pharmaceutical quality assurance or compliance role with external audit experience.

• Proactive with a high degree of self-discipline, drive and ability to work remotely or on-site with minimum supervision.

• Excellent communication skills to effectively interact with internal and external cross functional teams.

• Excellent in Microsoft Office Suite and Adobe Acrobat.

This job description for the Quality & Compliance Specialist outlines the primary responsibilities of the role and should not be considered a detailed description of all requirements that may be inherent in the job. The position is a hybrid position of remote work and in-office attendance with some domestic and international travel required to support the audit program as needed.

Location: Mississauga, Ontario

How to Apply: Please send us an email with your resume to careers@junopharm.com

NEW JOB POSTING: Regulatory Affairs Project Manager

dewantasinuzzaman@junopharma.com (Dewan Tasinuzzaman) — Thu, 19 Oct 2023 18:06:09 GMT

Regulatory Affairs Project Manager

Position Overview:

A Regulatory Project Manager at Juno Pharmaceuticals effectively prepares and manages assigned Regulatory Affairs projects to ensure successful growth and maintenance of the Juno product portfolio in a fast paced, sociable, upbeat and rewarding environment.

Responsibilities:

• Effectively manage assigned Regulatory Affairs projects independently and when needed incorporate the assistance of other staff or consultants to ensure a successful conclusion.

• Review, evaluate, prepare and submit submission to Health Canada and/or the US FDA.

• Review technical dossiers/packages for accuracy, completeness and compliance with Regulatory requirements and prepare gap reports.

• Ensure that submissions meet format and content requirement as well as ensure the accuracy and completeness of statement, data and conclusion in reports and summaries for inclusion in Regulatory submissions.

• Build and maintain a healthy working relationship with Regulatory Agencies. Use the relationship to understand expectations beyond that which is presented in guidelines and policy statements.

• Organize and facilitate meetings and teleconferences to maintain progress of projects. Track critical attributes of projects to ensure accountability and efficiency.

• Resolve any technical queries or deficiency letters relating to any submission in a timely manner within deadlines.

• Review, evaluate, prepare and submit responses to Health Canada and FDA requests for clarification/letters of deficiency.

• Collaborate with senior decision-makers to provide technical direction and prepare Regulatory strategies for new products under assessment.

• Provide regulatory counsel to ensure that all activities comply with regulations. Provide cross-functional input from an operational, scientific and technical viewpoint.

• Monitor regulatory maintenance of approved drug products. Maintain current awareness of regulatory guidelines (Health Canada, ICH, EMEA, FDA, etc.) and share knowledge with the department. Review Change Controls and determine filing requirements.

• Review and approve product labelling to meet regulatory requirements. Review promotional material to ensure compliance to Health Canada regulations, PAAB guidelines and/or ASC guidelines (as applicable).

• Perform other regulatory affairs functions and activities as assigned to achieve departmental or operational priorities and prioritizes other responsibilities to meet additional work requirements

• Build and maintain a healthy working relationship with business partners.

• Support provincial formulary submissions and drug product listing in co-ordination with Sales and Marketing department.

• Contribute to an efficient and effective regulatory affairs team.

Job Requirements:

• University Degree, B.Sc. or higher in Chemistry or Health Sciences.

• Regulatory Affairs Certification and/or a minimum of 5 years relevant experience in pharmaceutical Regulatory Affairs with Health Canada

• Regulatory Affairs experience with FDA an asset

• Detail oriented, superior problem-solving ability to identify solutions, planning, analytical and organizational skills to manage multiple concurrent projects within established timelines.

• Excellent communication (oral and written) and influencing skills; able to interact effectively and confidently both internally and externally.

• Proactive with self-discipline and competitive drive

• Strong interpersonal skills with ability to work effectively and efficiently.

• Strong computer skills including Microsoft Office Suite and Adobe Acrobat.

Reports to: Regulatory Affairs Manager

Location: Mississauga, Ontario

How to Apply:

Please send us an email with your resume to careers@junopharm.com

NEW JOB POSTING: Quality & Compliance Associate

dewantasinuzzaman@junopharma.com (Dewan Tasinuzzaman) — Mon, 11 Sep 2023 16:12:03 GMT

Quality & Compliance Associate

Job Summary:

The Quality & Compliance Associate jointly with the Manager, Quality is responsible for the quality assurance, quality control and quality compliance activities in support of the importation and distribution of JPC’s drug products.

The Quality & Compliance Associate will assist in the operational oversight and perform activities relating to establishment licensing, document control, batch record review, product dispositions, vendor qualification, self-inspections, complaints, deviations, CAPAs, SOP writing, change control, process validation, analytical method validation/transfer and the fulfilment of post market commitments.

The Quality & Compliance Associate acts as a positive influence toward quality awareness throughout the organization. The position requires detailed knowledge of Health Canada Food and Drug Act, regulations and guidance documents. The successful candidate is detail oriented and is able to demonstrate problem solving skills to identify solutions. The role requires analytical thinking and exceptional time management abilities to progress multiple concurrent projects within established timelines.

Essential Responsibilities:

• Create/write, revise, review and enforce Juno’s SOPs as needed to support operational activities.

• Support creation of training materials and provide SOP/GMP training as needed.

• Organize analytical testing for JPC’s incoming finished goods.

• Release drug products to the Canadian market ensuring compliance to Health Canada regulations.

• Support the creation and maintenance of quality system records, document filing and archival.

• Compile Annual Product Quality Review and Yearly Biologic Product Reviews.

• Document and report receipt of product complaints.

• Support the vendor qualification program by assisting with onsite or desk audits of JPC’s GMP service providers.

• Support the quality oversight of pharmaceutical manufacturing, packaging/labelling and testing deviations/non-conformance investigations and CAPA implementation at CMO’s and internally.

• Support maintenance of JPC’s drug establishment licence, Table A and GMP evidence of foreign buildings.

• Perform quality assurance impact assessment for internal and third-party related change control records.

• Review JPC’s product labelling for regulatory compliance.

• Support in any regulatory or third party audit of JPC as required.

• Review and evaluate product returns for disposition and destruction requests

• Perform additional duties as assigned by the Manager, Quality.

Qualifications:

• University degree (B.Sc. or higher) in Chemistry, Biology, Biochemistry or Health Sciences.

• Post-Graduate Certification in Regulatory Affairs and Quality Assurance preferred.

• Detailed knowledge of Canadian Food and Drugs Act and Regulations, Health Canada guidance documents, ICH guidance documents, GMPs and other relevant guideline with focus in sterile injectables.

• Minimum 0-3 years relevant Canadian experience in a pharmaceutical quality assurance or compliance role.

• Proactive with a high degree of self-discipline, drive and ability to work remotely or on-site with minimum supervision.

• Excellent communication skills to effectively interact with internal and external cross functional teams.

• Excellent in Microsoft Office Suite and Adobe Acrobat.

Location:

• Located in Toronto (GTA)

This job description for the Quality & Compliance Associate outlines the primary responsibilities of the role and should not be considered a detailed description of all requirements that may be inherent in the job.

How to Apply:

Please send us an email with your resume to careers@junopharm.com

Omega Laboratories est fier d'être partenaire avec Juno Pharmaceuticals

dewantasinuzzaman@junopharma.com (Dewan Tasinuzzaman) — Mon, 15 May 2023 12:35:19 GMT

Juno Pharmaceuticals est fier d'être partenaire avec Omega Laboratories

TORONTO (ON), le 15 mai 2023 – Juno Pharmaceuticals Canada (« Juno »), un chef de file dans la commercialisation de produits pharmaceutiques spécialisés, annonce aujourd’hui l’acquisition de Laboratoires Omega (« Omega »), l’un des plus importants fabricants canadiens de produits pharmaceutiques injectables spécialisés. La société résultant de cette acquisition est désormais l’une des plus importantes entreprises de produits injectables génériques du Canada ayant des capacités de fabrication nationales.

« Nous sommes fiers de cette acquisition qui renforce la capacité de Juno à améliorer l’approvisionnement en médicaments indispensables pour soutenir notre système de santé, affirme Marc Mantel, Président et PDG de Juno. Nous sommes une entreprise détenue et exploitée au Canada et nous continuerons de soutenir notre marché intérieur tout en nous développant dans de nouvelles régions avec des produits pharmaceutiques canadiens fiables et de haute qualité. »

Grâce à l’usine de fabrication de produits injectables récemment ouverte par Omega et approuvée par Santé Canada et la FDA américaine et au solide réseau commercial et aux canaux de développement de produits qu’elle possède, Juno va rapidement mettre sur pieds une gamme élargie de produits pharmaceutiques essentiels et les mettre e à disposition des praticiens et des patients. Au cours des quatre prochaines années, Juno prévoit l’introduction de plus d’une centaine de nouveaux produits sur le marché canadien, avec des expansions clés en gestion de la douleur, des solutions orales, des vaccins contre les allergies, des produits pour le diabète et favorisant la perte de poids, en plus du lancement d’offres uniques touchant le secteur dentaire, cosmétique et de la santé animale.

Cette association survient à un moment critique, alors que la vulnérabilité du Canada face au marché mondial continue à avoir des conséquences sur l’efficacité et l’accès à des produits pharmaceutiques essentiels et que les chaînes de production demeurent bloquées, et ce, même après la pandémie. En renforçant ses capacités de fabrication nationale, Juno contribuera à stabiliser le système de santé canadien tout en procurant un soulagement immédiat à bon nombre de pénuries de médicaments auxquelles sont actuellement confrontés les patients, tout en prévenant de futures pénuries.

« En combinant l’expertise d’Omega en matière de fabrication à la force commerciale de Juno, nous créons une entité conséquente au sein de l’industrie pharmaceutique canadienne et visons d’étendre notre portée à d’autres marchés grâce à nos médicaments de haute qualité, ajoute Bruce Levins, directeur de l’exploitation de Juno. Nous nous engageons à servir la population canadienne en investissant dans la production nationale, en protégeant et en créant des emplois locaux et en insufflant un système d’autosuffisance en ce qui concerne notre marché pharmaceutique intérieur. »

Juno prévoit d’amener plusieurs nouveaux produits au Canada, s’érigeant ainsi comme l’entreprise pharmaceutique nationale spécialisée ayant la plus forte croissance.

Juno Pharmaceuticals is proud to acquire Omega Laboratories

dewantasinuzzaman@junopharma.com (Dewan Tasinuzzaman) — Mon, 15 May 2023 12:35:14 GMT

Juno Pharmaceuticals is proud to acquire Omega Laboratories

TORONTO, ON May 15, 2023 – Today, Juno Pharmaceuticals Canada (“Juno”), a leader in the commercialization of specialty pharmaceuticals, announced the acquisition of Omega Laboratories (“Omega”), one of Canada’s largest domestic specialty injectable pharmaceutical manufacturers. The new combined company is now one of the largest specialty generic injectable businesses in Canada with domestic manufacturing capabilities.

“We are proud of this acquisition that solidifies Juno’s ability to improve drug supply with medications that are critically needed to support our healthcare system” said Mark Mantel, CEO of Juno. “We are Canadian owned and operated and will continue to support our domestic market while expanding into new geographies with dependable and high-quality Canadian-made pharmaceuticals.

Powered by Omega’s recently opened Health Canada and U.S. FDA approved injectable manufacturing facility and strengthened by Juno’s robust commercial network and product development pipeline, Juno will quickly bring an expanded array of critical pharmaceutical products to life and into the hands of medical practitioners and patients. Over the next four years, Juno expects to bring over 100 new products to the Canadian market with key expansions in pain management, oral solutions, allergy vaccines, diabetes & weight-loss and in addition, launch unique offerings in the dental, cosmetic, and animal health sectors.

This partnership comes at a critical time as Canada’s vulnerability to the global market continues to have repercussions for efficiency and access to critical pharmaceuticals, as supply channels remain pinched post-pandemic. By bolstering domestic manufacturing capabilities, Juno will aid in bringing stability to Canada’s healthcare system while providing immediate relief for many of the drug shortages presently facing patients, as well as preventing future shortages.

“Combining Omega’s manufacturing expertise and Juno’s commercial strength, we are creating a formidable player within Canada’s pharmaceutical industry with plans to expand our reach into other markets with our high-quality medications,” said Bruce Levins, COO of Juno.

“We are committed to serving Canadians by investing in domestic production, protecting and adding local jobs and creating a system of self-sufficiency when it comes to our domestic pharmaceutical market.”

Juno plans to bring multiple new products to Canada, establishing itself as the fastest-growing domestic specialty pharmaceutical business.

Bloom Burton Securities Inc. served as financial advisor and Aird & Berlis LLP acted as legal counsel to Juno in connection to the acquisition.

Joint Partnership Announcement

dewantasinuzzaman@junopharma.com (Dewan Tasinuzzaman) — Mon, 24 Apr 2023 16:51:55 GMT

Juno Pharmaceuticals Canada & Rosemont Joint Partnership Announcement

TORONTO, ON April 25, 2023 – Juno Pharmaceuticals Canada (“Juno”), a Canadian specialty pharmaceutical company, announced its partnership with U.K. based developer, manufacturer and global supplier of novel, Rx, oral liquid medicines, Rosemont Pharmaceuticals (“Rosemont”), as its exclusive Canadian distributor. Through this partnership, several of Rosemont’s oral liquid solutions will be filed with Health Canada in the coming months.

Oral liquid medicines can provide an easier to swallow, more appropriate formulation for patients with dysphagia (swallowing difficulties) or when requiring titration, which is a key concern in children, stroke patients, patients with dementia, patients with head and neck cancer, and people with intellectual disabilities.

“Many Canadians are unable to take solid dose tablets as prescribed, and alternative formulations are not readily available in the Canadian market,” says Mark Mantel, President and CEO of Juno. “This partnership will be instrumental to ensuring Canadian patients have access to the oral solutions that meet their unique needs, without sacrificing on medicinal quality.”

Rosemont brings over 50 years of experience in novel, Rx, oral liquid medicine and one of the broadest product portfolios in the world, with over 130 oral liquid medicines addressing a variety of therapeutic areas such as cardiac health, endocrinology, and pain management.

“As we continue to expand distribution, commercialization and manufacturing partnerships on a global scale, we are proud to be collaborating with Juno to supply these essential products to Canadian patients,” says Eric Vick, Chief Commercial Officer of Rosemont. “Together, we will continue creating innovative solutions that meet the needs of dysphagic patients and establish best practice for their care.”

About Rosemont Pharmaceuticals:

Rosemont Pharmaceuticals has over 50 years of experience delivering novel, Rx, oral liquid medicine solutions for patients with swallowing difficulties, across a range of therapeutic areas. As a trusted name in liquid medicine, Rosemont supplies to over 27 international markets, spanning North America, Europe, South America, the Middle East, Africa, Asia, and Oceania. At their state-of-the-art production facility in Leeds, they manufacture in excess of 1 million litres of bulk liquid, equating to 4 million bottles of liquid medicines per year. The quality of their supply chain partners, suppliers, relationships, and processes, and having manufacturing in house, enable them to achieve market leading levels of service to their customers of 99% on time, in full. With a portfolio of over 130 oral liquid medicines, Rosemont has one of the largest ranges of licensed, novel Rx oral liquid medicines in the world, extending across a wide range of therapy areas, meeting the needs of some of the most vulnerable patients in society.

New Product Launch

dewantasinuzzaman@junopharma.com (Dewan Tasinuzzaman) — Thu, 06 Apr 2023 18:44:45 GMT

New Product Launch: Bortezomib

Juno Pharmaceuticals is proud to announce the launch of Bortezomib. We are committed to providing innovative solutions to address patient needs and ensuring availability to those who require it. Our goal is to advance patient care through research, development, and innovative treatment options.

Bortezomib for Injection treats multiple myeloma and mantle cell lymphoma, used for previously untreated and relapsed patients. It's used as part of combination therapy and for those unsuitable for stem cell transplantation. The medication is also used for patients with mantle cell lymphoma who have undergone one prior therapy.

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Joint Partnership Announcement

dewantasinuzzaman@junopharma.com (Dewan Tasinuzzaman) — Thu, 06 Apr 2023 18:30:22 GMT

Juno Pharmaceuticals Canada & J. Molner Joint Partnership Announcement

J. Molner and Juno Pharmaceuticals Canada Announce joint partnership and licensing Agreement for Generic Injectable Drugs in Canada.

J. Molner, an Estonia-based pharmaceutical company specializing in the development of innovative generic drugs, and Juno Pharmaceuticals Canada, a Canadian specialty pharmaceutical company, announce a licensing agreement to commercialize two generic injectable drug products pending approval with Health Canada, and two generic injectable drug products under development at the J. Molner laboratory in Tallinn.

"We are pleased to partner with Juno Pharmaceuticals to bring our innovative generic injectable drugs to market in Canada," said Jason Grenfell-Gardner, CEO of J. Molner AS. "This agreement represents an important milestone for Molner, as it validates the strength of our product portfolio and our commitment to bringing affordable generic drugs to patients. We look forward to working closely with Juno to ensure the success of our products in Canada."

The licensed products are currently under review with Health Canada, and Molner anticipates approval of the first product later this year. Molner expects to receive additional regulatory approvals in Canada in the near future. The products will be supplied by Molner using contract manufacturers, while Juno will be responsible for the commercialization of the products in Canada.

"We are excited to partner with Molner to commercialize these important generic drugs in Canada," said Mark Mantel, CEO of Juno Pharmaceuticals. "Molner's innovative product portfolio and expertise in developing generic drugs make them an ideal partner for us. We look forward to working closely with Molner to ensure the success of these products in Canada.".

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NEW JOB POSTING: IT Director

dewantasinuzzaman@junopharma.com (Dewan Tasinuzzaman) — Tue, 04 Apr 2023 20:18:56 GMT

IT Director

The Director of Information Technology’s primary responsibility is to be responsible for the vision, planning and management of all company technologies. Responsible for the definition, implementation, evolution, reliability, and security of the organization's information and telecommunications systems in line with strategic objectives in a manufacturing environment.

Core Relationships:

Direct report to CFO / COO
Finance
Manufacturing and Operations
Internal & External Customers Regulatory & Quality
Warehousing Operations & Supply Chain
Other company divisions as needed and required by position

Essential Responsibilities:

Reports to the CFO and is a trusted partner of the COO, and it’s management leadership team.
Lead and manage a small IT team in a manufacturing environment with multiple sites/locations.
ERP and MRP experience preferably with JDE 9.2.
Lead integration of two entities from an IT perspective
Review and hone processes on IT asset management
Ensure the security of the IT environment.
Ensure the development of the architecture and complete technology structure of the corporate network.
Ensure the development and implementation of an organization's information and telecommunications systems strategy and policy.
Ensure the integrity of the computer system and network
Audit information systems to identify technological risks and opportunities.
Ensure the development and implementation of continuous improvement projects for the computer network.
Develop long term IT strategy and roadmap for the company.
Identify and implement enterprise-wide it-enabled business transformation initiatives.
Keep the network up to date through the implementation of technological solutions.
Design and develop corporate applications aimed at improving the operational efficiency of the company.
Steering and supporting the organization in the management of change.
Organize and lead exchanges with the CFO and the various business teams to identify needs.
Provide departments with unparalleled services based on their needs.
Leads team of IT staff.
Perform any other related task considered relevant as part of this position

Financial Acumen:

Accountable for current and future financial deal analysis
Contribute to Annual and long-range financial planning. Accountable to accurately budget departmental spending

What is expected of you at this level?

Accomplish the tasks defined in his job description.
Propose solutions to the constraints of the department.
Keep head of departments informed about the resources and tools to be made available to their department.
Achieve the objectives of his department and the company.

Qualifications:

Bachelor’s degree in computer science or information technology or equivalent.
More than 10 years of experience in a similar position.
Excellent analytical and strategic skills.
Experience in IT project management.
Familiar with more than one software development methodology.
Experience in implementing work methods that have helped improve productivity and the quality of deliverables.
Excellent analytical, decision-making and priority management skills.
Leadership, ability to support, train and motivate staff.
Have a sense of organization, rigor, and responsiveness.
Have a relational ease and sense of listening.
Knowledge of Good Manufacturing Practices (GMP) and the various regulations related to the pharmaceutical industry.
Bilingualism (English/French) and excellent written and oral communication skills.

Location:

Montreal based role

How to Apply:

Please send us an email with your resume to careers@junopharm.com

Noromby & Noromby HP New Switching Strategy

dewantasinuzzaman@junopharma.com (Dewan Tasinuzzaman) — Thu, 30 Mar 2023 18:59:39 GMT

Expanded Biosimilar Drug Programs in Saskatchewan, Newfoundland, and Labrador

We are excited to share that our biosimilar drug, Noromby, will now be covered as part of the expanded biosimilar drug programs in Saskatchewan, Newfoundland, and Labrador. As of March 31, 2024, Noromby will replace the current biologic branded product with our more affordable alternative medicine. This initiative will bring cost savings and further aid in the sustainability of our healthcare system, while also ensuring patients have access to safe and effective medication. We are proud to be part of the Biosimilars Initiative, which supports patient access to public drug coverage and new drug benefits.

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NEW JOB POSTING: Regulatory Affairs Associate

Thu, 26 Jan 2023 14:06:05 GMT

Regulatory Affairs Associate

Reporting to the Vice-President, Quality and Regulatory Affairs, the Associate will support all regulatory activities for complete product life-cycle. Responsibilities and duties include but are not limited to those described below:

Key Responsibilities and Primary Duties:

Key Responsibility: Preparation and Maintenance of Regulatory Registration

With guidance:

Prepare and submit all aspects of pre-market and post-market dossiers which include but are not limited to ANDS, NOS, DIN, Notifiable Changes, Supplements and annual changes.
Liaise and orchestrate meetings with cross functional departments and strategic partners to ensure timely submissions.
Critically review technical documents that support submissions.
Prepare responses to questions from Health Canada or other agency.
Prepare, review and approve product artwork and labels (including arranging French translation)
Author product specifications, method transfer protocols, transportation protocols or pharmaceutical equivalence protocols, as necessary.
Source, assemble and ship study supplies.
File and maintain foreign sites on MDA's Drug Establishment License.
Prepare and file PCPA and provincial formulary submissions
Prepare tech transfer of approved submission documents to Quality upon NOC.
Track and ensure the successful completion of post-approval commitments.
Support product launch activities.
Assess impact of post-approval changes in regards to approved submissions and project manage the receipt of supporting data and documentation.
Provide administrative and related project support including materials for pre-submission meetings, submission dossier publishing and structure-product-labelling
Maintain MDA's regulatory filing system
Other duties as directed.

Qualifications

Educational Requirements:

Minimum Bachelor of Science Degree
Graduate of Regulatory Affairs Postgraduate Certificate Program (preferred)

Industry Experience:

Minimum 1 year experience in quality systems or regulatory affairs within the pharmaceutical industry, specific experience with parenteral products is preferred.
Sound knowledge and application of Canadian regulations.

Special Skills:

Ability to work collaboratively in a professional and effective manner across MDA departments and with external partners.
Strong investigation and problem-solving skills
Strong project management skills (manage and prioritize multiple tasks)
Ability to plan and organize available resources and activities in-order to reach predefined goals
Experience in using computer programs (MS Word, Excel, and Access)
Strong verbal and written communication skills
Ability to respond quickly to a changing regulatory environment

Juno Pharmaceuticals receives approval from Health Canada to import Amoxicillin amidst nationwide shortage

Wed, 04 Jan 2023 18:13:07 GMT

Juno Pharmaceuticals is importing Amoxicillin to combat dwindling supplies of children’s antibiotics

TORONTO, ON January 4, 2023 – Juno Pharmaceuticals Canada (“Juno”), a Canadian specialty pharmaceutical company, announced that it has received approval from Health Canada to import Amoxicillin powder for oral suspension (“Amoxicillin”) pursuant to Health Canada’s exceptional importation and sale guidelines. This approval will help relieve the current nationwide shortage of a critical antibiotic product and most importantly, allow it to reach pediatric and geriatric patients alike. Through this initiative with both its vendor partners and importation approval from Health Canada, Juno has procured close to 100,000 bottles. Delivery of the first order is underway with the remaining orders expected throughout January. The product will be distributed to hospitals, pharmacies and retail wholesalers in every province and territory.

Canada is experiencing a nationwide shortage of antibiotics while respiratory illnesses and infections surge. Amoxicillin oral suspension is one of the most commonly prescribed antibiotics for children for the treatment of particular bacterial infections. It has been widely reported that Amoxicillin has been in critically short supply – and in some cases, on backorder – since October 2022. Dwindling supplies of Amoxicillin have had to be rationed across Canada and have forced some pharmacies to dispense alternative formulations.

“The imported products from Juno have undergone careful review to ensure that they meet Canadian standards for safety and efficacy, and this brings us closer to ending the current shortage in the Canadian market.” says Paul Varady, VP of Quality and Regulatory Affairs at Juno.

In response to the increasing drug shortages being experienced across Canada, Juno recently launched an internal drug shortage division focused on sourcing, registering and importing out-of-country medications through its trusted global partner network. Amoxicillin represents the first product that Juno will successfully import to address drug shortages through this division. An additional eight products experiencing critical shortages in Canada are currently being sourced and are under review for possible submission to Health Canada.

“The ongoing shortage of antibiotics has put additional pressure on our already over-burdened healthcare system,” says Mark Mantel, President & CEO of Juno. “The addition of our drug shortage division is critical to helping alleviate significant strain on the Canadian healthcare system by combatting the depletion of multiple antibiotic medicines. Canadians will soon be able to access some of the antibiotics that they desperately need.”

About Juno Pharmaceuticals Canada

Juno Pharmaceuticals Canada specializes in bringing complex and high value generic and biosimilar products to the Canadian market. The Juno management team possess decades of pharmaceutical industry experience along with an extensive track record of driving strategic growth through the identification of niche products and disciplined construction of robust product pipelines. An early member of the global Juno Pharmaceuticals group, Juno’s global operations span four continents and consist of over 14 diverse pharmaceutical and medical device businesses spread across Canada, the United Kingdom, the European Union, Australia and South Africa.

Media Contact

Maxine Bullock

Maxine.Bullock@kaiserpartners.com

647.460.5990

Juno Pharmaceuticals reçoit l’autorisation de Santé Canada pour importer de l’amoxicilline dans le cadre de la pénurie nationale

Wed, 04 Jan 2023 18:13:06 GMT

Juno Pharmaceuticals importera de l’amoxicilline pour pallier la diminution des réserves d’antibiotiques pour enfants

TORONTO, ON January 4, 2023 - Juno Pharmaceuticals Canada (« Juno »), une société pharmaceutique canadienne spécialisée, annonce avoir obtenu l’autorisation de Santé Canada pour importer de l’amoxicilline en poudre pour suspension orale (« Amoxicilline ») conformément aux lignes directrices sur l’importation et la vente exceptionnelles de Santé Canada. Cette autorisation permettra de pallier la pénurie nationale actuelle d’un produit antibiotique essentiel et, surtout, de le mettre à la disposition des patients pédiatriques et gériatriques. Grâce à cette initiative avec ses partenaires fournisseurs et à l’autorisation d’importation de Santé Canada, Juno a fourni environ 100 000 bouteilles. La livraison de la première commande est en cours et les autres commandes sont attendues au cours du mois de janvier. Le produit sera distribué aux hôpitaux, aux pharmacies et aux grossistes-détaillants dans chaque province et territoire.

Le Canada traverse une pénurie d’antibiotiques à l’échelle nationale, alors que les maladies et infections respiratoires sont en forte hausse. La suspension orale d’amoxicilline est l’un des antibiotiques les plus couramment prescrits aux enfants pour le traitement de certaines infections bactériennes. Depuis octobre 2022, il a été largement rapporté que l’amoxicilline est en grave pénurie et, dans certains cas, en rupture de stock. Les réserves d’amoxicilline, qui sont en baisse, ont dû être rationnées à travers le Canada et ont obligé certaines pharmacies à délivrer des formulations alternatives.

« Les produits importés par Juno ont fait l’objet d’un examen minutieux pour s’assurer qu’ils répondent aux normes canadiennes en matière de sécurité et d’efficacité, et cela nous rapproche de la fin de la pénurie actuelle sur le marché canadien » déclare Paul Varady, vice-président de la qualité et des affaires réglementaires chez Juno.

En réponse aux pénuries croissantes de médicaments que connaît le Canada, Juno a récemment lancé une division interne en charge des pénuries de médicaments axée sur l’approvisionnement, l’enregistrement et l’importation de médicaments hors du pays par l’intermédiaire de son réseau mondial de partenaires de confiance. L’amoxicilline est le premier produit que Juno réussira à importer pour remédier aux pénuries de médicaments grâce à cette division. Huit autres produits qui sont en pénurie critique au Canada sont en cours d’approvisionnement et font l’objet d’un examen en vue d’une éventuelle soumission à Santé Canada.

« La pénurie actuelle d’antibiotiques a accentué la pression sur notre système de santé déjà surchargé, explique Mark Mantel, président et chef de la direction de Juno Canada. L’ajout de notre division en charge des pénuries de médicaments est essentiel pour alléger la pression importante sur le système de santé canadien en luttant contre l’épuisement de plusieurs médicaments antibiotiques. Les Canadiens pourront bientôt avoir accès à certains des antibiotiques dont ils ont désespérément besoin. »

À propos de Juno Pharmaceuticals Canada

Juno Pharmaceuticals Canada se spécialise dans la commercialisation de produits génériques et biosimilaires complexes à haute valeur ajoutée sur le marché canadien. L’équipe de gestion de Juno possède des dizaines d’années d’expérience dans l’industrie pharmaceutique ainsi qu’une vaste expérience dans l’accélération de la croissance stratégique par l’identification de produits de niche et la création disciplinée de portefeuilles de produits robustes. Les opérations mondiales de Juno, un des premiers membres du groupe mondial Juno Pharmaceuticals, s’étendent sur quatre continents et comprennent plus de 14 entreprises diverses de produits pharmaceutiques et de dispositifs médicaux réparties au Canada, au Royaume-Uni, dans l’Union européenne, en Australie et en Afrique du Sud.

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Maxine Bullock
Maxine.bullock@kaiserpartners.com
6 4 7.460.5990

ALERTE SUR LA QUALITÉ DES PRODUITS: Chlorhydrate de dexmédétomidine injectable, 4 mcg/mL (400 mcg/100mL)

Tue, 20 Dec 2022 14:19:57 GMT

Renseignements détaillés :

Juno Pharmaceuticals Canada (JPC) est au courant d'une préoccupation potentielle concernant la qualité de son produit Chlorhydrate de dexmédétomidine injectable, 4 mcg/mL (400 mcg/100mL), DIN 02487373, CUP / GTIN : 00841629000145. JPC a reçu trois (3) plaintes du marché canadien depuis novembre 2022 pour ce produit.

La préoccupation est spécifique à deux produits finis distribués sur le marché, à savoir, les lots AGB217 et AGB218, et concerne la difficulté de l'étiquette intégrée de suspendre le flacon.

Tel qu’illustré ci-contre, la difficulté de l’étiquette intégrée de suspendre le flacon peut entraîner la chute du flacon lorsqu'il est suspendu pendant l'administration de la dose.

Chlorhydrate de dexmédétomidine injectable, 4 mcg/mL est un agoniste alpha ₂ -adrénergique et constitue une nécessité médicale.

Le produit est utilisé comme traitement de première intention pour obtenir, dans l’unité de soins intensifs, la sédation des patients initialement intubés et ventilés mécaniquement pendant le traitement, dans un cadre de soins intensifs.

Le produit est également utilisé pour obtenir la sédation de patients non intubés avant et / ou pendant des procédures chirurgicales et d’autres procédures par perfusion intraveineuse continue.

JPC fournira une mise à jour sur la résolution de la préoccupation relative à la qualité du produit en question à tous les professionnels de la santé et aux groupes d'achat dès que nous aurons conclu notre enquête et mis en œuvre des mesures correctives et préventives appropriées.

Pour toute question ou pour signaler des inquiétudes concernant la qualité d'un produit, veuillez contacter notre Service de la qualité à l'adresse suivante Quality@junopharm.com , ou notre centre d'information médicale à medinfo-PV@junopharm.com ou en composant le 1-(866)-663-1747.

Stratégie d'atténuation

Pour continuer à utiliser le format de remplissage de 100 mL (400 mcg / 100 mL), JPC recommande aux professionnels de la santé d'éviter d'utiliser les languettes de suspension intégrées à l'étiquette du flacon et d'utiliser des cintres en plastique pour les flacons de perfusion, lorsque cela est possible et que le nécessaire est disponible. Nous travaillons également avec nos fournisseurs pour trouver et fournir des cintres en plastique à utiliser avec le format de remplissage de 100 mL.

JPC dispose d'un format alternatif de Chlorhydrate de dexmédétomidine injectable, 4 mcg / mL, présenté en 200 mcg / 50 mL dans une formulation prête à l'emploi. JPC demande aux groupes d'achat et aux professionnels de la santé de bien vouloir passer au format de remplissage de 50 mL.

Une alternative supplémentaire est disponible sous forme de Chlorhydrate de dexmédétomidine pour injection USP, 100 mcg / mL, qui nécessite une dilution avant utilisation.

Si vous avez des questions sur la disponibilité des produits, veuillez contacter notre équipe de vente à l'adresse suivante : Sales@junopharm.com .

Sincères remerciements,

Mike Tersigni

JPC, Responsable de l’Assurance de la qualité

Quality@junopharm.com

PRODUCT QUALITY CONCERN: Dexmedetomidine Hydrochloride Injection 400 mcg/ 100 mL

Fri, 16 Dec 2022 20:13:47 GMT

Details:

Juno Pharmaceuticals Canada (JPC) is aware of a potential product quality concern with our Dexmedetomidine Hydrochloride Injection 4 mcg/mL (400 mcg/100mL) DIN 02487373, UPC/GTIN: 00841629000145. JPC has received 3 complaints from the Canadian market since November 2022 for this product.

The concern is specific to 2 market distributed finished goods lot AGB217 and lot AGB218 and involves the failure of the integrated vial hanging label.

The failure of the integrated vial hanging label may cause the vial to fall while hung during dosage administration.

Dexmedetomidine Hydrochloride Injection 4 mcg/mL is a Alpha ₂ -adrenergic agonist and is a medical necessity.

The product is used as a first line therapy to achieve intensive care unit sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting.

The product is also used to achieve sedation of non-intubated patients prior to and/or during surgical and other procedures by continuous intravenous infusion.

JPC will provide an update on the resolution of the product quality concern to all HCP’s and buying groups as soon as we have concluded our investigation and implemented appropriate corrective and preventative actions.

For questions or to report a product quality concerns please contact our quality department at: Quality@junopharm.com , or, our medical information center at medinfo-PV@junopharm.com or 1-(866)-663-1747.

Mitigation Strategy.

To continue using the 100 mL fill format (400 mcg/100 mL), JPC is recommending that healthcare practitioners avoid using the integrated vial hanging tabs on the vial label and utilize plastic hangers for infusion bottles, where possible and available. We are also working with our suppliers to source and provide plastic hangers for use with the 100 mL fill format.

JPC has an alternate size format of Dexmedetomidine Hydrochloride Injection 4 mcg/mL presented as 200 mcg/50 mL in a ready to use formulation. JPC is requesting that buying groups and healthcare practitioners switch to the 50 mL fill format.

An additional alternative is available as Dexmedetomidine Hydrochloride for Injection USP, 100 mcg/mL which requires dilution prior to use.

Should you have any product availability questions please contact our sales team at: Sales@junopharm.com.

Thank you,

Mike Tersigni

JPC Quality Assurance Manager

Quality@junopharm.com

Signet Healthcare Partners Completes Growth Equity Investment in Juno Pharmaceuticals Corp.

thomas@mawazo.ca (Mawazo Marketing) — Fri, 23 Sep 2022 14:21:58 GMT

Signet Healthcare Partners Completes Growth Equity Investment in Juno Pharmaceuticals Corp.

February 24, 2022 08:30 AM Eastern Standard Time

TORONTO--( BUSINESS WIRE )--Juno Pharmaceuticals Corp (“Juno”), a Canadian specialty generics pharmaceuticals company, announced that it has received a strategic growth investment from Signet Healthcare Partners (“Signet”), a New York-based healthcare growth equity firm. Juno intends to use these proceeds to expand its complex and high-value generic and biosimilar portfolio and to accelerate growth.

James Gale, Managing Director of Signet said, “We are very pleased with the opportunity to partner with the Juno management team. They have decades of pharmaceutical industry experience and have built a growing business. They have done so through astute product selection and a disciplined approach to building their pipeline. We look forward to contributing to this effort.”

Ian Jacobson, Chief Executive Officer of Juno noted, “I am very happy to welcome Signet as a key investor in the future of Juno. We believe Signet will further enhance Juno’s already strong growth profile given their extensive experience in pharma, and specifically with generics. We look forward to working with the Signet team building Juno into one of the leading generic pharmaceutical companies in Canada.”

Aird & Berlis LLP acted as legal counsel for Juno Pharmaceuticals Corp and Sheppard, Mullin, Richter & Hampton LLP acted as legal counsel for Signet Healthcare Partners.

About Juno Pharmaceuticals Corp

Juno Pharmaceuticals Corp specializes in bringing complex and high value generic and biosimilar products to the Canadian market. The Juno management team possesses decades of pharmaceutical industry experience along with an extensive track record of driving strategic growth through the identification of niche products and disciplined construction of robust product pipelines. An early member of the global Juno Pharmaceuticals group, Juno’s global operations span four continents and consist of over 10 diverse pharmaceutical and medical device businesses spread across Canada, the United Kingdom, the European Union, Australia and South Africa.

About Signet Healthcare Partners

Signet Healthcare Partners ("Signet") is an established provider of growth capital to innovative healthcare companies. Signet invests in commercial-stage healthcare companies that are revenue generating or preparing for commercial launch. The firm's focus has primarily been on the pharmaceutical sector and medical technology companies. Signet maintains a disciplined, yet flexible investment approach. As an active investor, Signet partners closely with its companies to build their value including facilitating activities between portfolio companies. During Signet's 23-year history, it has developed a strong reputation and track record of successful investments. Signet has raised four funds with total capital commitments of over $400 million and has invested in more than 55 companies. For more information, visit www.signethealthcarepartners.com .

Introducing NOROMBY & NOROMBY HP (Enoxaparin sodium solution)

thomas@mawazo.ca (Mawazo Marketing) — Tue, 23 Mar 2021 14:00:11 GMT

Health Canada Approves Juno’s Enoxaparin Biosimilar

On October 14, 2020, Juno Pharmaceuticals Corp. (JPC) received a Notice of Compliance from Health Canada for Noromby and Noromby HP, biosimilar biologic drugs to Lovenox® and Lovenox HP® (the reference biologic drug). The approval is a significant milestone not only in JPC’s corporate development, marking the rapidly growing pharmaceutical company’s first entry into the local biosimilars market, but is of broader significance for Canadian healthcare as the first enoxaparin sodium biosimilar to be approved in Canada.

Authorization of a biosimilar means that it is highly similar to the reference biologic drug in terms of quality, efficacy and safety between the two products. Authorization of Noromby and Noromby HP was granted for all of the indications that are currently authorized for Lovenox and Lovenox HP.

The anticoagulant/antithrombotic agent has been approved for both intravenous administration and subcutaneous injection, and in multiple strengths, including 20 mg/0.2mL, 30 mg/0.3mL, 40 mg/0.4mL, 60 mg/0.6mL, 80 mg/0.8mL, 100 mg/mL, 120 mg/0.8mL and 150 mg/mL.

Enoxaparin sodium is commonly used in the treatment/prevention of both pulmonary embolism and deep vein thrombosis, conditions which account for approximately 65% of global consumption of LMWHs. Enoxaparin has also previously been used to treat patients suffering from acute coronary syndrome.

Introducing Bortezomib 2.5mg

thomas@mawazo.ca (Mawazo Marketing) — Fri, 02 Oct 2020 17:08:00 GMT

Juno Pharmaceuticals Corp. is pleased to announce the launch of new strength of

BORTEZOMIB for Injection 2.5mg per vial

Product is now available at wholesalers.

Introducing Dexmedetomidine (RTU)

thomas@mawazo.ca (Mawazo Marketing) — Fri, 02 Oct 2020 17:04:49 GMT

Juno Pharmaceuticals Corp. is pleased to announce the launch of the:

Dexmedetomidine Hydrochloride Injection 4 mcg / mL (RTU) vial

400 mcg / 100 mL & 200 mcg / 50 mL

Product is now available at wholesalers.

Introducing Ertapenem 1g for Injection

thomas@mawazo.ca (Mawazo Marketing) — Sun, 02 Feb 2020 00:51:59 GMT

Juno Pharmaceuticals Corp. is pleased to announce the launch of Ertapenem 1g for Injection.

Product is now available at wholesalers.

Introducing Carbetocin Pre-Filled Syringes for Injection

thomas@mawazo.ca (Mawazo Marketing) — Thu, 02 Jan 2020 00:51:59 GMT

Juno Pharmaceuticals Corp. is pleased to announce the launch of Carbetocin 100 mcg/mL.

Product is now available at wholesalers.

juno-pharmaceuticals

Juno - CPHI Conference 2024

Juno - CPHI 2024

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Quality & Compliance Specialist

Quality & Compliance Specialist

NEW JOB POSTING: Regulatory Affairs Project Manager

Regulatory Affairs Project Manager ﻿

NEW JOB POSTING: Quality & Compliance Associate

Quality & Compliance Associate

Omega Laboratories est fier d'être partenaire avec Juno Pharmaceuticals

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Juno Pharmaceuticals is proud to acquire Omega Laboratories

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Joint Partnership Announcement

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New Product Launch

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NEW JOB POSTING: IT Director

IT Director

Core Relationships:

Essential Responsibilities:

Financial Acumen:

What is expected of you at this level?

Qualifications:

Noromby & Noromby HP New Switching Strategy

Expanded Biosimilar Drug Programs in Saskatchewan, Newfoundland, and Labrador

NEW JOB POSTING: Regulatory Affairs Associate

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Juno Pharmaceuticals receives approval from Health Canada to import Amoxicillin amidst nationwide shortage

Juno Pharmaceuticals reçoit l’autorisation de Santé Canada pour importer de l’amoxicilline dans le cadre de la pénurie nationale

Juno Pharmaceuticals importera de l’amoxicilline pour pallier la diminution des réserves d’antibiotiques pour enfants

ALERTE SUR LA QUALITÉ DES PRODUITS: Chlorhydrate de dexmédétomidine injectable, 4 mcg/mL (400 mcg/100mL)

PRODUCT QUALITY CONCERN: Dexmedetomidine Hydrochloride Injection 400 mcg/ 100 mL

Signet Healthcare Partners Completes Growth Equity Investment in Juno Pharmaceuticals Corp.

Introducing NOROMBY & NOROMBY HP (Enoxaparin sodium solution)

Introducing Bortezomib 2.5mg

Introducing Dexmedetomidine (RTU)

Introducing Ertapenem 1g for Injection

Introducing Carbetocin Pre-Filled Syringes for Injection

Regulatory Affairs Project Manager