Principal Scientist, Cell Based Sciences Analytical R&D
About The Position
Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. We deliver robust scientific data and interpretation that drives the development and commercialization of breakthrough therapeutics. Using innovative thinking, state-of-the-art facilities, and robust scientific methodology, we collaborate to discover the next medical breakthrough. The Analytical Research and Development (AR&D) Cell-Based Sciences Department is seeking a Principal Scientist with deep technical expertise in developing critical reagent strategies for large molecules. This senior scientific role will partner closely with the Director and lead a team of scientists to design and execute technical, scientific, and regulatory strategies for critical reagents that support the development of the company’s biologics and vaccine products. The ideal candidate will be an expert in developing critical reagents for analytical methods supporting monoclonal antibodies, recombinant proteins, and other large molecule modalities such as live viral vaccines. The successful candidate will provide scientific leadership, expertise, and creativity to solve complex problems across the large molecule portfolio. Candidates must demonstrate: Strong organizational, project management, and multitasking skills Proven scientific leadership and a track record of innovation. Excellent written and oral communication skills The Principal Scientist will be expected to communicate effectively with stakeholders in partner organizations as well as with senior management and governance teams. Prior experience leading small groups of technical personnel, driving projects, and contributing to group or departmental strategy will be a significant differentiator. In this role, the Principal Scientist will: Define and implement large molecule critical reagent strategies. Oversee reagent qualification and testing, documentation, and lifecycle management. Oversee both internally and externally sourced reagent development, production, and implementation to support the large molecule pipeline. Represent the group on cross-functional product development teams. Provide technical and scientific leadership to a group of approximately 3–5 scientists. Provide scientific mentoring and coaching to staff. We are seeking a collaborative leader with strong interpersonal and mentoring skills, and a passion for developing people and working across functional boundaries.
Requirements
- Ph.D. in analytical chemistry, molecular biology, cell biology, virology, or related field with a minimum of 8 years of relevant experience in Biopharmaceutical Industry. OR M.S. with a minimum of 10 years of relevant experience in Biopharmaceutical Industry. OR bachelor’s with a minimum of 14 years of relevant experience in Biopharmaceutical Industry.
- Deep working knowledge of regulatory guidance and quality standards, with experience devising reference standard strategy for large molecules (Vaccines and Biologics including therapeutic proteins, monoclonal antibodies, Antibody-drug conjugates).
- Candidates should have experience with authoring and reviewing regulatory submissions, and prior Health Authority engagements (e.g., Biologics license application submission).
- Demonstrated project management skillset to oversee, prioritize, and deliver on critical reagents large molecule portfolio of projects.
- Experience with monitoring reagent/ assay performance and control for drifts in key quality attributes between and within reference standards, and analytical bridging studies.
- Demonstrated ability to work independently and collaborate effectively with cross-functionally in a team-based environment, partnering and influencing in a professional and effective manner.
- Excellent verbal and written communications skills.
Responsibilities
- Lead, supervise, and mentor a team of scientists developing critical reagents to support our Research & Development Division's Large Molecule Development portfolio.
- Represent or provide technical oversight of team members on product development working groups.
- Collaborate effectively in a multidisciplinary team environment and provide technical input to enable team decisions.
- Lead and provide technical oversight on the authoring and reviewing of critical reagent documents including reagent development reports, technical summaries, and reagent qualification protocols.
Benefits
- The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
- We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
- More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
Education Level
Ph.D. or professional degree
