Senior Scientist, Reagent Technical Development and Operations (On-site)
We are seeking a highly motivated Senior Scientist to join the Reagent Technical Development and Operations team within the Large Molecule Analytical (LMA) Cell-Based Sciences Department in West Point, PA. The qualified candidate will develop critical reagent strategies for large molecule products across the biologics and vaccines pipeline, partnering with cross-functional analytical development teams, regulatory, and quality to deliver Biological Critical Reagent strategies throughout the development lifecycle.
About the role
The successful candidate will provide scientific leadership, expertise, and creativity to solve complex project problems across the large molecule portfolio. This role requires effective organizational skills to support multiple programs, demonstrated scientific expertise in analytical development, and superior written and oral communication skills. The candidate will collaborate with stakeholders in partner organizations, management, and governance teams.
Responsibilities
- Define, develop, and implement large molecule critical reagent strategies.
- Oversee and analyze reagent qualification testing, documentation, and lifecycle management.
- Oversee internally and externally sourced reagent development, production, and implementation to support the large molecule pipeline.
- Collaborate with cross-functional teams to support biologics development.
- Maintain accurate and detailed laboratory records.
- Contribute to the preparation of regulatory submissions and technical reports.
- Develop Critical Reagent strategies for program-specific reagents to support the company’s Large Molecule Development portfolio.
- Represent or provide technical oversight of team members on analytical and product development working groups.
- Collaborate effectively in a multidisciplinary team environment and provide technical input to enable team decisions.
- Author and review critical reagent documents including reagent development reports, technical summaries, and reagent qualification protocols.
Qualifications
- Ph.D. in analytical chemistry, molecular biology, cell biology, virology, or a related field.
- OR M.S. with a minimum of 3 years of relevant experience in the Biopharmaceutical Industry.
- OR bachelor’s degree with a minimum of 7 years of relevant experience in the Biopharmaceutical Industry.
Skills
Required
- Demonstrated project management skillset to oversee, prioritize, and deliver on critical reagents for the large molecule portfolio.
- Experience monitoring reagent/assay performance and control for drifts in key quality attributes between and within reference standards, and analytical bridging studies.
- Ability to work independently and collaborate effectively in a cross-functional, team-based environment.
- Excellent verbal and written communication skills.
- Analytical Chemistry, Analytical Method Development, Assay Development, Biochemical Assays, Biopharmaceutical Industry, Biopharmaceuticals, Cell-Based Assays, Immunoassays, Innovative Thinking, Molecular Microbiology, Project Management, Scientific Leadership, Stakeholder Communications, Strategic Thinking, Teamwork, Technical Writing.
Preferred
- Bioanalytical Analysis, Chromatographic Techniques, GMP Operations.
Schedule
This is a lab-based role and is not eligible for a hybrid work model. The position follows a 1st-shift (day) schedule.
Pay
The salary range for this role is $117,000.00 - $184,200.00. An employee’s position within the salary range will be based on factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
Benefits
We offer a comprehensive package of benefits, including:
- 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 Merck Compensation and Benefits.