Senior Scientist, Engineering

Job Description

We are seeking a strategic and technical team player with expertise in cell culture commercialization. The primary objective of the Biologics Drug Substance Commercialization (BDSC), Cell Culture Sciences department is to provide the technical leadership and laboratory capabilities in support of late-stage pipeline commercialization and post-market commercial manufacturing support. BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation, second generation process development and authoring of regulatory submissions. 

Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in conjunction with internal and external partners, this individual will support late stage and commercial large molecule biologics program activities. The individual will be responsible to support development activities, commercialization activities of late-stage pipeline and/ or post-market commercial manufacturing 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.

• 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.

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

• 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.

• 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 six (6) years of relevant industry experience

OR

• Master’s degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with four (4) years of of relevant industry experience

OR

• Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with a no minimum relevant knowledge

Required Experience and Skills:

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

• Expertise in 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.

• Experience and aptitude to work and collaborate in internal and external cross-functional, matrixed teams.

• Action-oriented, mindset for creativity; ability to take initiative, innovate, iterate, and problem-solve.

• Excellent interpersonal and communication skills

Preferred Experience and Skills:

• Experience in CMC development teams.

• Experience with cell culture process development for biologics.

• Experience with high throughput microbioreactor systems, and advanced in situ analytics for process monitoring and control

• Experience with state-of-the-art cell culture processes including intensified inoculum/fed-batch and perfusion process development.

• Background in data science approaches related to cell culture and predictive modeling e.g., (metabolic flux (MFA) analysis, omics, machine learning; experi