Overview You join the Pharmaceutical Development team to advance biologics drug product development. You will execute studies, and as experience grows, lead smaller work items under supervision, while supporting formulation, process development, and analytical characterization. You'll work with internal and external partners to drive progress across multiple projects in a fast-paced setting. This role offers hands-on instrument work, method development, and opportunities to contribute to tech transfer and clinical material production.
Responsibilities- Set up, operate, and maintain laboratory instruments; help develop methods and draft procedures, reports, and SOPs
- Independently run experiments and potentially lead small, well-defined studies in formulation and drug product process development
- Analyze data, identify trends, and propose next steps within project constraints; escalate complex issues
- Draft study plans, memos, and development reports with review from senior colleagues
- Collaborate with cross-functional teams (QA, analytical, R&D, manufacturing) and external partners to support development activities and tech transfer
- Communicate progress, timelines, results, risks, and recommendations to management and project teams
- Perform physicochemical and bioanalytical characterization using standard instrumentation; contribute to method optimization
- Prepare samples, solvents, standards, and buffers with proper calculations and GxP-compliant documentation
- Maintain notebooks, study documentation, inventory, and instrument maintenance; mentor less-experienced colleagues on procedures
- Perform other duties as assigned
Key requirements- Relevant experience in formulation, drug product, analytical, or related biologics development
- Hands-on experience with biologics characterization/analytical instruments and ability to troubleshoot routine issues
- Ability to analyze results, summarize findings, and make data-driven recommendations within defined parameters
- Strong technical writing skills for SOPs, reports, and memos
- Capability to conduct basic to moderately complex formulation and drug product studies with appropriate guidance on study design
- Understanding of aseptic processing and sterile fill-finish concepts for parenteral biologics
- Knowledge of GxP principles and regulatory expectations for biologics (preferred)
- Experience supporting pharmaceutical product development, scale-up, tech transfer, or clinical manufacturing (preferred)
- Excellent organization and ability to manage multiple studies and meet deadlines
- Effective team player with clear communication across cross-functional partners
- GDP and disciplined laboratory record keeping in regulated environments
- Willingness to learn and apply feedback to more complex tasks
- Solid safety awareness in bioanalytical/pharmaceutical labs
- collaborative
- clear communication
- problem-solving
- UPLC/HPLC (SEC, RP, HIC, IEX/CEX, CAD preferred)
- charge variant analysis
- particle analysis
