Senior Scientist, Biologics Analytical R&D (On-site) Full-time

Senior Scientist

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 Senior Scientist 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 apply separation-based analytical methods, including HPLC, UPLC, CE, and iCIEF, to support method optimization, phase-appropriate validation, analytical method transfer, lifecycle management, and GMP testing. The incumbent will collaborate with Analytical Development, Large Molecule Assay Validation, Quality Assurance, Technical Operations, CMC Regulatory Affairs, and external stakeholders to resolve technical challenges, provide scientifically sound guidance, and drive pipeline progress.

Responsibilities

• Validate, implement, transfer, and maintain analytical methods supporting clinical material testing and commercialization readiness.
• Act as a new project lead by collaborating with external stakeholders and managing validation and testing activities for assigned programs across the team.
• Serve as a subject matter expert across biologics programs, products, and analytical platforms.
• Interpret and review analytical data, assess trends, support investigations, deviations, CAPAs, and data-driven technical decisions.
• Execute and oversee GMP release, stability, and in-process analytical testing for biologics drug substance and drug product using established and advanced analytical technologies.
• Provide scientifically sound recommendations to address technical challenges and support decision-making across development stages.
• Support biologics registrations, product launches, and technical troubleshooting.
• Build and manage project timelines and deliverables to drive milestone completion.
• Support audits, inspections, investigations, and CAPA activities through disciplined documentation and inspection-ready practices.
• Ensure analytical activities are conducted in accordance with cGMP expectations, data integrity principles, and applicable regulatory requirements.
• Support instrument qualification activities, including IQ/OQ/PQ, as needed.
• Contribute to strategic initiatives and cross-functional improvement efforts across matrixed teams.
• Author and review technical documentation, including regulatory submissions.
• Support evolving departmental priorities through flexible scientific and operational contributions.

Qualifications

• Ph.D. in Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with a minimum of 2 years of relevant experience or
• M.S. with a minimum of 3 years of relevant experience; or
• B.S. with a minimum of 7 years of relevant experience.

Experience and Skills

Required

• Minimum of 2 years of experience working in a GMP or regulated laboratory environment.
• Demonstrated technical expertise with separation-based analytical methods, including HPLC, UPLC, CE, iCIEF, or other advanced technologies.
• Strong organizational and project management skills, with demonstrated ability to manage timelines, deliverables, and proactively communicate risks.
• Demonstrated ability to resolve technical issues using innovative, scientifically sound solutions.
• Ability to work independently and effectively within a fast-paced, multidisciplinary matrix team.
• Excellent oral and written communication skills.
• Strong interpersonal and leadership skills, with the ability to lead through influence in a matrixed environment.
• Self-motivated, accountable, and results-oriented.
• Willingness to occasionally work evenings, weekends, or irregular hours to support business needs.

Preferred

• Experience supporting GMP release, stability, and in-process testing for biologics drug substance or drug product.
• Proficiency with GMP laboratory systems, including LIMS, electronic notebooks, Empower, and/or data analytics platforms.
• Knowledge of cGMP, ALCOA+, and key regulatory expectations, including USP, ICH, and FDA guidance.
• Proficiency with analytical method development, validation, transfer, lifecycle management, and/or regulatory submissions.
• Involvement in biologics late-stage development, commercialization, registration, or product launch activities.
• Strong technical writing skills for scientific, GMP, and/or regulatory documentation.
• Experience with UV spectrophotometric, compendial, or platform analytical methods.
• Applied knowledge of deviation, investigation, CAPA, and change control processes.
• Contributions to continuous improvement or Lean Six Sigma initiatives.