Senior Scientist, Engineering- Cell Banking

About the role

The successful candidate will be responsible for commercialization activities on late-stage pipeline and/or post-market commercial manufacturing working cell banks for biologics and/or vaccines. Activities include cell bank process assessments and transfers, manufacturing investigations and trend evaluations, process characterization, new WCB qualification, and regulatory submission authoring, with a focus on standardization across programs.

Responsibilities

• Direct projects focusing on cell bank process risk assessments, documentation, process characterization, technology transfer and qualification of new cell banks with line-of-sight for licensure and commercialization.
• Responsible for planning and executing work to support commercialization of working cell banks, identification and implementation of process changes for replenishment lots, control strategies, manufacturing operations, investigation evaluations, and regulatory filings.
• Design, plan, and execute laboratory experiments to generate high quality data.
• Perform data analysis and ensure results are reported clearly and accurately and effectively communicate study results to stakeholders via presentations and technical reports.
• Collaborate with research and commercial teams to deliver process documentation packages, review batch records, support technology transfer activities, and provide investigation support for cell bank manufacturing, both within our Company network and at contract manufacturing organizations (CMOs).
• Author required regulatory and technical documentation associated with cell bank process transfer, long term storage stability, qualification and licensure.
• Ensure that process/product are developed and documented according to standard company practices.
• Support regulatory queries and inspections as required.
• Provide technical leadership in the assessment of program-specific cell bank processes, interpretations of cell bank performance, as well as qualification approaches across programs.
• Implement and sustain technical standardization of best practices across the network.
• Lead assignment execution against accelerated timelines, in a right-first-time manner, with a “safety first, compliance always” mindset.

Requirements

• Minimum Required Education and Experience: Bachelor’s Degree in Biochemistry, Bioengineering, Biochemical Engineering, Biological Engineering, or Chemical Engineering with five (5) years of cell culture experience in pharmaceutical industry; OR Master’s degree in Biochemistry, Bioengineering, Biochemical Engineering, Biological Engineering, or Chemical Engineering with three (3) years of cell culture experience in pharmaceutical industry; OR Ph.D. in Biochemistry, Bioengineering, Biochemical Engineering, Biological Engineering, or Chemical Engineering.
• Required Expertise and Skills: Fundamental understanding of cell line development, cell culture growth metabolism, cell death, and media adaptation. Hands-on experience and expertise in mammalian and/or microbial, adherent and/or suspension cell culture, including cell enumeration and expansion, virus infection, cryopreservation, cell bank preparation, and laboratory scale process operations in cell culture stacks, shake flasks, and/or 2L bioreactor systems. Expertise in upstream lab scale experimental execution, Design of Experiments (DOE), statistical data analysis and presentation of results/conclusions. Experience authoring technical documentation to support regulatory submissions. Outstanding communication and people skills. Ability to foster a collaborative work environment, focused on common goals and working across boundaries. Acute problem-solving skills, project management, and keen ability to navigate work in an ambiguous environment.

Preferred Skills

• Large molecule cell line/process development, including laboratory and/or GMP manufacturing of upstream processes. Hands-on expertise with mammalian cell culture bench scale and ability to oversee teams through these requirements as lab lead.
• Experience with on-the-floor Good Manufacturing Practice (GMP) manufacturing support, manufacturing batch record reviews and/or operations.
• Expertise with Quality by Design (QbD) and Lean Six Sigma principles.
• Working understanding of US/EU regulatory requirements and analytical methods required to ensure viral safety and characterization of cell banks, and working knowledge of cGMP principles and regulations.
• Expertise supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA, EMA, JNDA, TGA).