Principal Scientist, Engineering

Job Description

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

Under the general scientific and administrative direction of Director in BSS, this individual will support late stage and commercial large molecule programs with a focus on biologics downstream processing, including multi-specific antibody therapeutics, among other complex biologics modalities. The individual will manage a team of downstream scientists and will ensure that BDSC delivers an outstanding level of rigor in our scientific work and manufacturing support activities. 

Technical Scope:  

• Leads downstream and/or overall drug substance teams focusing on late-stage clinical process development, characterization, and technology transfer and validation with line-of-sight for licensure and commercialization. 

• Drives division wide initiatives that will enable our Company’s biologics manufacturing strategic goals.

• Provides technical leadership for laboratory-scale and manufacturing scale studies to support commercial process validation, characterization, and investigations, including studies performed either in-house or externally. 

• Primary focus will be on downstream processing, but with a working knowledge of the various aspects of product manufacture and functional area interdependencies, including cell culture, analytical, and GMP site readiness. 

• Actively interacts with internal and external partners.  Represents functional area on cross-functional and cross-divisional teams.

• Authors required regulatory and technical documentation.  Ensures that process/product are developed and documented according to standard of our Company practices.

Education Minimum Requirement:

• BS, MS or PhD in Chemical Engineering/Biological Engineering/Chemistry with a minimum of 14 years (for BS), 12 years (for MS), or 8 years (PhD) relevant industry experience. 

Required Experience and Skills:

• Strong fundamental knowledge and subject matter expertise in downstream processing of biologics

• Expertise in independently conducting and directing the design, execution, analysis, and documentation for all stages of process development.

• Knowledge and experience of biologics commercialization

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

  • Experience and aptitude to lead, 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.

  • Demonstrated commitment to coach and mentor staff to maximize talent development and utilization.

• Excellent oral and written communication skills.  Demonstrated ability to effectively articulate understanding of process science, to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.

Preferred Experience and Skills:

• Leadership in drug substance working group team.

• People management experience

• Experience with technology transfer (scale-up and validation) of processes to pilot and manufacturing scales for biologics manufacture.

• In-depth knowledge of preparative chromatography, tangential flow filtration, and virus retaining filtration desired.  Demonstrated understanding of the fundamentals and/or modeling of unit operations is a plus.

• Prior experience with developing multi-specific antibody therapeutics, including a wide variety of bispecific or multi-specific antibody formats.  

• Prior experience in late-stage process development, process characterization including viral clearance studies, process performance qualification and validation, authoring regulatory BLA sections and/or working with external contract organization for development and or manufacturing.

• Working understanding of analytical methods to characterize biologics