Position Summary
- Test and release materials that support safe, effective medicines; work across manufacturing, quality, and technical teams.
Responsibilities
- Perform and train others on testing lab samples (raw materials, in-process, product, water) using chemical, biochemical, and microbiological methods.
- Prepare samples, standards, and solutions; maintain accurate laboratory records.
- Conduct environmental monitoring, bioburden, and endotoxin testing.
- Manage sample lifecycle and associated physical/electronic documentation.
- Lead and participate in laboratory investigations, data review, and corrective actions.
- Support instrument lifecycle activities, validations, technical transfers, and routine lab upkeep.
Basic Qualifications
- Bachelorβs degree in Chemistry, Biochemistry, Microbiology, or Biology.
- Minimum 2 years of laboratory experience in a regulated (GxP/cGMP) environment.
- Hands-on experience with routine wet chemistry or microbiology techniques.
- Strong attention to detail; experience maintaining accurate lab records.
- Ability to collaborate with manufacturing and quality teams.
- Willingness to work occasional weekends or off-shift coverage as required.
Preferred Qualifications
- Biopharmaceutical testing methods (HPLC/UPLC, ELISA, CGE, SEC, PCR, protein concentration assays).
- Environmental monitoring/bioburden/endotoxin/disinfectant efficacy testing.
- LIMS/LES/SAP/ERP and Microsoft Office.
- cGxP, ICH guidelines, data integrity expectations, compendial standards.
- Analytical method transfers, instrument qualification, or validations; continuous improvement; lab housekeeping.
Work Model and Location
- On-site at a United States facility; occasional off-shift/weekend coverage.
How to Apply
- Submit a current resume and a short note describing what excites you about the role and how you meet basic qualifications.