Scientist, Biologics Analytical R&D (On-site)
About The Position
Join a team dedicated to advancing lifesaving and life-enhancing medicines through exceptional scientific oversight of our company's biologics portfolio from development through commercialization. Grounded in ethics, integrity, transparency, and scientific rigor, we bring together diverse perspectives to deliver transformative medicines. We are seeking a Scientist (R2) to join our Biologics Analytical Research & Development (AR&D) GMP Operations team in North Wales, PA, part of the West Point campus footprint. The ideal candidate brings strong technical judgment, GMP discipline, and cross-functional collaboration skills to support biologics development and commercialization. The successful candidate will execute testing of compendial and separations-based analytical methods, including HPLC, UPLC, CE, and iCIEF. The incumbent will collaborate with Analytical Development, Large Molecule Assay Validation, Quality Assurance, Technical Operations, CMC Regulatory Affairs, and external stakeholders to validate analytical methods and support release and stability testing.
Requirements
- Minimum of 1 year experience working in a GMP environment
- Experience with separation techniques such as HPLC, UPLC, CE, iCIEF, or other advanced technology.
- Proficiency with data analytics.
- Understanding and adherence to ALCOA principles for documentation.
- Strong organizational skills and ability to manage work to meet project timelines.
- Capability to work independently with minimal supervision.
- Ability to identify and resolve common technical issues.
- Effectively engage, communicate, and collaborate with others.
- Self-motivated with a positive attitude, strong interpersonal skills, and aptitude for learning.
- A willingness to occasionally work irregular hours, including evenings and weekends, to support business needs.
Nice To Haves
- Technical expertise with compendial testing such as visible and sub-visible particles, pH, osmolality, color, and/or clarity.
- Knowledge of USP, EP, ICH, and FDA regulations.
- Experience with LIMS, Empower, electronic notebook, and/or other data analytics platforms.
- Knowledge of deviation management and change control processes.
Responsibilities
- Validate and implement analytical methods to support release and stability testing of clinical materials.
- Execute Good Manufacturing Practices (GMP) activities such as release, stability, and in-process testing of Biologics Drug Substance (DS) and Drug Product (DP).
- Act as subject matter expert (SME) across various franchises and analytical platforms.
- Support biologics registrations, product launches, and troubleshooting activities.
- Support compliance audits, inspection activities, and investigation/CAPAs.
- Author and review technical documents.
- Complete assigned work within established project timelines.
- Ensure adherence to GMP standards and facilitate ongoing enhancement of laboratory processes.
- Manage laboratory equipment, laboratory supplies and critical reagent inventories.
- Support instrument qualification activities, including IQ/OQ/PQ, as needed.
- Additional responsibilities as assigned to support the evolving needs of the department.
Benefits
- medical
- dental
- vision healthcare
- other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
- annual bonus
- long-term incentive
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
