QC Stability Analyst job in Lexington, USA

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Last Name*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

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Phone Number*

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Job type: Permanent

Discipline: Biochemistry, Biological Sciences, Laboratory Technician

Location: United States

This vacancy has now expired. Please see similar roles below...

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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