Summary:
Research Associate 1 (Analytical Sciences) in Process Analytics & Services (PAS). Hands-on laboratory role supporting analytical testing and characterization of therapeutic candidates across process development, early clinical, late-stage, and commercial programs.
Key Responsibilities:
- Perform routine and non-routine analytical testing to support Drug Substance/Drug Product process development and lifecycle programs
- Execute assays including: HPLC/UPLC; CE and gel electrophoresis (e.g., SDS-PAGE); UV/Vis and FTIR; ELISA (plate-based) and cell-based bioassays; basic nucleic acid and compendial physicochemical testing
- Document test results in accordance with GMP/GLP and internal procedures; analyze/interpret data and communicate results clearly
- Support method qualification, optimization, validation, and transfer activities (under supervision)
- Draft/update technical documents (analytical procedures, protocols, reports)
- Troubleshoot analytical methods and laboratory workflows; maintain equipment and ensure readiness of reagents/standards/materials
- Provide analytical testing support for process development, manufacturing, and investigations; support in-process, release, and stability testing
- Ensure work is performed per GxP requirements and maintain inspection-ready laboratory documentation/data; support inspections/audits
- Document experimental plans/results/conclusions; maintain organized electronic records; present data/progress updates
- Contribute to continuous improvement and support training/knowledge sharing
Required Skills/Qualifications:
- Hands-on experience with one or more analytical techniques (HPLC/UPLC, CE, ELISA, spectrophotometry)
- Basic understanding of GMP/GLP and data integrity expectations
- Ability to analyze and interpret data
- Strong written/oral communication; strong organizational skills; ability to work independently and collaboratively
- Bachelorβs degree in Biochemistry, Chemistry, Biology, Analytical Chemistry, or related; 1β2 years relevant experience in pharma/biotech
Preferred Skills:
- LC/HPLC/UPLC and CE experience; biopharmaceutical development/protein characterization
- Bioassays or cell-based assay experience
- Analytical method lifecycle experience (qualification/troubleshooting/validation/transfer)
- Cross-functional or fast-paced environment experience
Education/Experience:
- Masterβs degree is a plus (not required)
Additional Information:
- Fully onsite laboratory role; routine handling of chemicals and biological materials with safety practices; occasional flexibility for operational needs.