QC Stability Analyst

Proclinical is currently recruiting for a QC Stability Analyst with a biopharmaceutical company located in Lexington, MA.

Job Responsibilities:

• 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.

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