QC Stability Analyst
Proclinical is currently recruiting for a QC Stability Analyst with a biopharmaceutical company located in Lexington, MA.
- Manage stability externally and internally.
- Strong ability to write stability protocols.
- Pulling samples for testing and setting samples down on stability, reviewing stability data and writing stability summary reports at each timepoint. Trend the data.
- Summarizes and critically analyzed data for trending and reporting.
- Independently organizes work flows to accomplish objectives, provides guidance and support to colleagues as needed, promotes new policies and programs tactfully.
- Plan and support execution of internal as well as outsourced stability studies of exosomes, biological molecules, oligonucleotides, small molecules, and drug products.
- Assist in building and maintaining strong working relationships with technical counterparts at CROs, CDMOs. Strong GMP experience and working in a QC lab.
Skills and Requirements:
- BS and/or MS degree in biochemistry, cell biology and/or molecular biology discipline;
- At least 5 years work experience in a GMP environment in a QC Lab;
- Background in methodologies supporting both biologics and small molecules;
- Direct experience in authoring and review of SOPs, protocols and reports;
- Strong knowledge of cGMP/ICH/FDA/EU regulations;
- Excellent communication, project management, and presentation skills (oral and written)
If you are having difficulty in applying or if you have any questions, please contact Sarah Beshara at 267-477-3355.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.