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

About the role

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.

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).
• 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.
• 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.

Qualifications

• Minimum of a B.A./B.S. degree in biology, biochemistry, or related scientific field with 3 years of relevant experience in analytical development, validation, and/or quality control, or M.S. degree with a minimum of 1 year of relevant experience.
• 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.
• Able 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.

Preferred Technical Expertise

• 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.
• Knowledge of compendial testing such as visible and sub-visible particles, pH, osmolality, color, and/or clarity.