Sr. Scientist, Pharmaceutical Development

Job Title:

Scientist, Pharmaceutical Development

Job Description

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.

Essential 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.

+ BS in Biotechnology, Biochemistry, Pharmaceutical Sciences, or a related field with 4+ years of relevant experience, OR MS with 2+ years of relevant experience.

Additional

Skills & Qualifications

+ 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…