Senior Scientist, Reagent Technical Development and Operations (On-site)
About The Position
The Large Molecule Analytical (LMA) Cell-Based Sciences Department is seeking a highly motivated Senior Scientist to join the Reagent Technical Development and Operations team in Cell-Based Sciences department in West Point, PA. The qualified candidate will be responsible for developing critical reagent strategies for large molecules products across the biologics and vaccines pipeline. This senior scientist role will partner with cross-functional analytical development teams, regulatory and quality to deliver related Biological Critical Reagent strategies through the development lifecycle of a program. The successful candidate is expected to provide scientific leadership, expertise, and creativity to solve complex project problems across the large molecule portfolio in developing critical reagents strategies. Applicants must have effective organizational skills that enable support of multiple programs, have demonstrated excellent scientific expertise in analytical development, and have superior written and oral communications skills. The candidate will be expected to effectively communicate with stakeholders in partner organizations and with management and governance teams.
Requirements
- Ph.D. in analytical chemistry, molecular biology, cell biology, virology, or related field.
- OR M.S. with a minimum of 3 years of relevant experience in Biopharmaceutical Industry.
- OR bachelor’s with a minimum of 7 years of relevant experience in Biopharmaceutical Industry.
- 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.
Nice To Haves
- Bioanalytical Analysis
- Chromatographic Techniques
- GMP Operations
Responsibilities
- Define, develop and implement large molecule critical reagent strategies.
- Oversee and analyze reagent qualification testing, documentation, and lifecycle management.
- Oversee both 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 our Company's Research Laboratories 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.
Benefits
- medical
- dental
- vision healthcare
- other insurance benefits (for employee and family)
- retirement benefits
- 401(k)
- paid holidays
- vacation
- compassionate and sick days
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
