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Distinguished (Executive) Scientist, Biologics Process Development

Employer
Merck & Co.
Location
Kenilworth, NJ
Start date
Nov 15, 2023

We are seeking an exceptional scientific leader for the role of Distinguished Scientist (equivalent to the Executive Director level) in Biologics Process Development (BPD) group within the Biologics Process Research and Development (BPR&D) organization at Kenilworth, NJ.

 

The candidate will serve as the overarching scientific leader in BPD, the group responsible for developing upstream and downstream fed batch/ continuous processes for biologics in our company's pipeline. The incumbent will be responsible for conceiving our end-to-end scientific strategy, establishing a relevant technology roadmap, and subsequently facilitating its execution. The candidate will be an SME in the upstream or downstream process development and will play a key role in reinforcing and evolving our scientific leadership in biologics development and manufacturing. The candidate will collaborate with other development areas (including Analytical Development and Drug Product Development) as well as Discovery, Clinical Manufacturing, Commercial Manufacturing, Regulatory, and Marketing teams to progress our pipeline and platforms for biologics including antibodies, bispecifics, fusion molecules, and antibody drug conjugates.

 

Additionally, the role encompasses maintaining and enhancing our external collaboration network with academia, industry, and NGOs, and strengthening our scientific presence through publications and conferences. The candidate will participate in external regulatory forums to bring the evolving knowledge to our company and influence regulatory landscape related to the manufacturing and launch of biologics. The candidate, working alongside key partners, will also influence the strategy for data analyses and modeling approaches for BPD organization.

 

The candidate will be a member of the BPD Leadership Team and report directly to the Executive Director (Head of Bioprocess Development). The incumbent will be expected to represent the group in due diligence and regulatory activities. The candidate will also mentor and develop scientific talent and high-performing teams with members of varied background and advance our company's commitment to a diverse and inclusive work environment.

 

Education:

  • PhD in Chemical/Biochemical Engineering, Biochemistry, Biology, Pharmaceutical Sciences, or a relevant field.

 

Required Experience and Skills:

  • A minimum of 15 years of experience in drug substance process development for biologics/ vaccines; exposure to all stages and aspects of the product life cycle is required.

  • Extensive experience and in-depth knowledge in upstream, downstream, analytical development, or/and continuous manufacturing for biologics/vaccines.

  • Proficient with major cell type (E.coli, yeast, CHO, etc.) used for producing biologics.

  • Experience in CMC or program management, with proven track record of multiple successful submissions for biologics/vaccines.

  • Excellent understanding of mechanistic modeling of downstream processes, AI/ML, metabolic engineering, system biology, or/and data analyses strategies.

  • Strong knowledge of global regulatory requirements for biologics/vaccines.

 

Preferred Experience and Skills:

  • Recognized as a scientific leader nationally/ internationally for expertise in biologics/vaccines process development, exemplified by a track record of successful collaboration with industry and academia, recognition of work via professional organizations, or/and demonstration of research impact via citations, awards, and nominations.

  • Proven record to define a compelling vision to push the boundary of the biologics field, derive the scientific strategy accordingly, and implement practical solutions in process development and manufacturing settings.

  • Working knowledge on Analytical and Drug Product development and manufacturing and relevant innovations.

  • Exceptional scientific and communication abilities to influence senior management across functional areas to steer scientific strategy and policy.

  • Demonstrated expertise in addressing complex challenges for pipeline management through critical thinking, innovation, scientific rigor, and cross-functional collaboration.

  • Consistent delivery aligned with business/strategic needs while advancing the field.

  • Demonstrated ability to apply growth mindset to promote innovative culture within teams and partnerships.

  • Proven track record of developing diverse talent and building high performance teams. 

  • Demonstrated insight and organizational intelligence to lead changes under ambiguous situations.

 

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