Sr. Scientist, Pharmaceutical Development
About the role
This Scientist, Pharmaceutical Development role focuses on supporting biologics drug product development through hands-on laboratory experimentation, physicochemical characterization, formulation development, and analytical testing. You will independently design and execute studies, interpret complex data, and prepare clear scientific documentation to advance protein-based therapeutics. The position offers the opportunity to work with state-of-the-art analytical technologies, contribute to innovative biologic drug products, and collaborate closely with cross-functional teams in a fast-paced pharmaceutical development environment.
Responsibilities
- Independently plan and execute laboratory studies to support biologics drug product and formulation development.
- Perform routine and advanced HPLC/UPLC analyses, including SEC, RP, HIC, IEX/CEX, CAD, and CE-SDS, to characterize protein-based therapeutics.
- Run and interpret iCiEF and other charge variant analyses to assess biologic molecule quality and heterogeneity.
- Conduct particle characterization and related analyses to support drug product stability and quality assessments.
- Prepare samples, buffers, and reagents according to established protocols and good laboratory practices.
- Perform physicochemical characterization and support formulation development, stability studies, process development, and drug product optimization activities.
- Analyze experimental data, identify trends or atypical results, and draw scientifically sound conclusions to inform development strategies.
- Author and review technical documents, including SOPs, protocols, reports, and study plans, with strong attention to detail and data integrity.
- Maintain, operate, and troubleshoot liquid chromatography systems and other analytical instruments to ensure reliable performance.
- Ensure accurate and complete laboratory documentation, including electronic and paper records, in accordance with regulated pharmaceutical or biotech environment expectations.
- Collaborate with cross-functional teams such as Analytical Development, Quality, Manufacturing, Project Management, and external partners to support development objectives.
- Support technology transfer activities and clinical manufacturing efforts, including fill-finish and related operations for biologics drug products.
- Balance multiple concurrent development programs and prioritize tasks effectively in a fast-paced project environment.
- Contribute to characterization strategies and process development initiatives for biologics drug product programs.
- Participate in a two-round interview and onboarding process and integrate quickly into a collaborative pharmaceutical development laboratory setting.
Skills
- Hands-on experience executing HPLC/UPLC methods, including SEC, RP, HIC, IEX/CEX, CAD, and CE-SDS, for biologics characterization.
- Demonstrated experience with liquid chromatography systems, including operation, maintenance, and troubleshooting.
- Required experience with imaged capillary isoelectric focusing (iCiEF) methods for characterization of biologic molecules.
- Direct experience in biologics drug product and formulation development, including stability studies, process development, characterization, and drug product optimization for protein-based therapeutics.
- Strong understanding of biologics, protein chemistry, and protein characterization techniques.
- Proficiency in charge variant analysis and particle analysis for protein-based drug products.
- Ability to analyze experimental data, identify trends or atypical results, and provide scientifically grounded interpretations.
- Strong technical writing skills for authoring SOPs, protocols, reports, and study plans.
- Experience working in regulated pharmaceutical or biotechnology environments, including familiarity with GMP-related expectations.
- Strong organizational and project management skills, with the ability to support multiple concurrent development programs.
- Background in biochemistry, chemistry, or related life sciences disciplines supporting protein and biologics development.
- Experience with fill-finish operations and knowledge of drug product manufacturing workflows for biologics.
- Familiarity with broader analytical development strategies and cross-functional pharmaceutical development activities.
- Ability to work effectively in a collaborative environment and communicate clearly with scientists and partners from multiple disciplines.
- Comfort working in fast-paced project settings and adapting to evolving priorities.
- Strong attention to detail and commitment to data integrity and quality in all laboratory and documentation activities.
Qualifications
BS in Biotechnology, Biochemistry, Pharmaceutical Sciences, or a related field with 4+ years of relevant experience, OR MS with 2+ years of relevant experience.
Benefits
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance