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 processes are transferred to CMO, oversight of GMP manufacturing activities, as well as outsourcing to contract development laboratories.
Finally, this position will have administrative responsibilities for developing the necessary resources required to perform delegated assignments. This is a full-time position reporting to the Vice-President of Manufacturing.
Duties and 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 in 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 in 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 in team and project management.
- Experienced in Risk Assessment (i.e.: FMEA).
- Advanced experience in upstream, downstream processing, and fill/finish for biologicals in a GMP manufacturing environment.
- Strong experience and knowledge of 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 negotiation 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!
