Associate Prin. Scientist, Engineering

Job Description

As part of Our Company’s Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the Cell Culture and Fermentation Sciences (CCFS) department provides the technical process leadership and laboratory capabilities in support of late-stage pipeline and post-market commercial manufacturing processes for vaccines and biologics. CCFS supports various commercialization activities, second generation process development including process characterization, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions.  

Under the general scientific and administrative direction of Director in the CCFS group and working in conjunction with internal and external partners, this individual will support late stage and commercial large molecule program activities within CCFS. The individual will be responsible for leading a team to support development activities, commercialization activities of late-stage pipeline and/ or post-market commercial manufacturing vaccines and biologics. For commercial programs, activities include site-to-site process transfers, manufacturing investigations and trend evaluations, process enhancements, next generation process development and characterization, process validation, and regulatory submission authoring

In this role, the successful candidate will be responsible to

• Coordinate project planning, resourcing, progress reporting, troubleshooting and people management.

• Serve as the scientific/technical mentor for junior staff.  Provide technical guidance in the various aspects of Cell Culture process development/commercialization for large molecule products.

• Responsible for process development, process characterization and regulatory filing activities to ensure a smooth and clear path to successful PPQs and BLAs for the company's pipeline.

• Manage large multifaceted projects as the leader of a cross-functional team. 

• Ensures project results meet requirements regarding technical quality, reliability, schedule, and cost.

• Monitors performance and recommends schedule changes, cost adjustments or resource additions.

• Solves technical and non-technical problems throughout the life of the project, tries to resolve problems during the design and planning phases whenever possible.

• Provides timely and accurate information and status updates to project sponsors and management.

• May be responsible for managing large multifaceted projects as the leader of a cross-functional team.  

• Champion compliance and safety; promote a culture of diversity, inclusion, and equity.

Minimum Education Requirement and Experience:  

• Bachelor’s degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with eight (8) years of technical expertise in cell culture and fermentation sciences, leadership and project management, and regulatory knowledge in the Pharmaceutical/Biotech industry OR

• Master’s degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with six (6) years of technical expertise in cell culture and fermentation sciences, leadership and project management, and regulatory knowledge in the Pharmaceutical/Biotech industry OR

• Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with four (4) years of technical expertise in cell culture and fermentation sciences, leadership and project management, and regulatory knowledge in the Pharmaceutical/Biotech industry

Required Experience and Skills:

• Strong fundamental knowledge and subject matter expertise with mammalian cell culture processing of biologics (large molecule products), recent advances, and challenges in the field

• Expertise in independently conducting and directing the planning, execution, analysis, and documentation of all stages of cell culture process commercialization.

• Experience with late-stage commercial process development (CPD), technology transfer (TT), scale-down model qualification (SDMQ) and process characterization (PC).

• Experience authoring technical documentation in support of the following: process characterization (PC), process performance qualification (PPQ), risk assessment (RA), control strategy, process comparability reports, and/or regulatory submissions (BLA/MAA/JNDA etc.).

• Adaptability and agility to prioritize and deliver complex objectives, often on tight timelines, in a rapidly changing environment.

• Expe