Manufacturing Sciences Manager, Biologics

Job Description

35Pharma is a clinical-stage biopharmaceutical company focused on developing best-in-class transforming growth factor-beta (TGF-beta) superfamily ligand traps for pulmonary hypertension, obesity and cardiometabolic diseases. We believe in connecting rigorous science with our innate sense of urgency to rapidly generate breakthrough therapies for patients in need to better quality of life. Our highly qualified team of drug developers and company builders has a track record of advancing complex biologics from discovery through clinical trials. Our R&D facilities are located in the heart of Montreal, Canada, and comprise laboratory space for pre-clinical research as well as manufacturing development that bolster our mission to serve patients in need.

Role:

You will love this role if you have a passion for innovative science and medicine, you thrive in a fast-paced environment and enjoy contributing to drug development in an integrated communicative team environment.

The Manufacturing Sciences Manager’s role is to guide process development and analytical development strategies using a risk-based approach and develop product manufacturing control strategies. The manager will exert a leadership role in organizing the quality by design (QbD) platform necessary for the preparation of process qualification and during commercial stage, continuous process verification.

The manager will also provide support during process and analytical technological transfer and changes, as well as during process scale-up at the manufacturing sites.

Based on process and analytical validation guidance and regulatory requirements, the incumbent will prepare and/or review the related regulatory filings section.

Other responsibilities include usage of best scientific/industrial practices in the development and/or use of new processes to ensure scalable process are transferred to CMO, oversight of GMP manufacturing activities, as well as outsourcing to contract development laboratories.

Finally, this position will have administrative responsibilities of developing the necessary resources required to perform delegated assignments.

This is a full-time position reporting to the Vice-President of Manufacturing.

Responsibilities:

• Develop and manage a manufacturing science platform for process and analytics for biological products using a quality by design approach
• Ensure that a risk assessment is performed to support the decision-making process
• Directly participate to technology transfer and process scale up to recipient contractors’ facilities
• Develop process qualification strategy and lead execution
• Lead and execute the preparation of comparability protocols
• Ensure timely continuous process verification
• Participate to regulatory filings
• Ensure adequate work distribution and execution within defined timelines, whether internally or using outsourced resources
• Develop a team of professionals and scientists participating in manufacturing sciences using Quality by Design and validation activities according to cGMP
• Act as a subject matter expert and use scientific knowledge and industry best practices in use for process validation
• When required, provide oversight during manufacturing activities.

Qualifications:

• Master’s (M.Sc.) degree in pure or applied sciences or equivalent
• At least 10 years of experience in the biopharmaceutical industry, especially in development and validation of biologics manufacturing processes
• At least 5 years of experience of team and project management
• Experienced in Risk Assessment (i.e.: FMEA)
• Advanced experience in upstream, or downstream processing, and fill/finish for biologicals in a GMP manufacturing environment
• Strong experience and knowledge of the Good Manufacturing Practices (GMP) in a regulated environment (pharmaceutical)
• Solid experience in process validation (as per FDA 2011 guidance)
• Experienced with technology transfer and scale up
• Capable of planning, organizing, and prioritizing work in a fast-paced environment
• Experience using statistical tools
• Experience in problem solving and negotiations skills will be an asset.

Please send your CV and cover letter outlining your motivation and relevant experience for the role to careers@35pharma.com quoting “35Pharma Posting SMB1203” in the subject line – we are looking forward to hearing from you!

Job Types: Full-time, Permanent

Benefits:

• Commuter benefits
• Company events
• Dental care
• Disability insurance
• Employee assistance program
• Extended health care
• Flexible schedule
• Life insurance
• Paid time off
• Vision care
• Wellness program

Schedule:

• Monday to Friday

Work Location: In person