1 month ago
Boston generous bonus and stock options Permanent
Job Reference: LMO_1632235310
Senior/ Principal Engineer, Large Molecule Process Development
Leadership level position
Principal / Associate Director
Drug Substance & Drug Product
Our client, a fully integrated biopharmaceutical leader, focus on developing innovative medicines that make a meaningful difference to people living with addiction, mental illnesses, and cancer.
This company is based in Boston and has multiple sites across the US and Europe, with the shared goal of pursuing great science with deep compassion, striving to make a real impact on the lives of patients, families, and communities.
Our client is looking for a Senior or Principal Engineer who can lead the development and scale-up of large molecule drug product unit operations (batch/continuous) and will provide technical oversight to external contract manufacturers to ensure the successful manufacture of Phase 1 to 3 clinical supplies. The ideal candidate would have a strong background in Chemical Engineering and would be able to show a strong lab presence. This role will initially involve managing one junior scientist, with plans to have multiple direct reports as the team continues to grow and develop over the next 12-18 months.
- Collaborate within cross-functional teams, specifically with Formulation and Analytical Development to execute development strategies that enable successful launch of products
- Develop large molecule drug product unit operations (batch/continuous) with a focus on process understanding, identification of critical process parameters and process optimization
- Execute small scale drug product experiments to support process development
- Design manufacture processes and control strategies that deliver drug product of desired attributes for clinical production
- Write technical reports and deliver presentations to technical, CMC and broader project groups.
- MSc/ PhD in a relevant discipline, such as Chemical Engineering, with at least 2 years' experience working in the industry
- Strong background in batch or continuous drug product unit operations including aseptic fill/finish and lyophilization
- Pharmaceutical cGMP manufacturing and process validation experience
- Prior managerial experience or the aim to manage in the future would be desirable
- Team player with a positive, adaptable can-do attitude
Please don't hesitate to contact us or apply to this advert to arrange a discussion, or contact Ali Bagheri at firstname.lastname@example.org. We are excited to hear from you!
Keywords: Large Molecule, Biologics, Process Development, Pharmaceutical, Manufacturing, Lyophilization, GMP, Aseptic Fill/ Finish, Biologics