Quality Control, Associate Biochemist

Job description

Details:
Why GSK? Because GSK's Biopharm business vision is to leverage its experience and technical capabilities to launch, supply, and manage Biopharmaceutical products around the world. It will fulfill GSK's Mission to Do More, Feel Better, and Live Longer by living its values: Integrity: Always doing the right thing; Commitment to the Patient: Making the Patient the #1 Priority; Customer Service: Commit to delivering on promises to internal & external customers; Compliance – Being accountable for quality and safety.

GSK Biopharm in Rockville MD has an opening for an Associate Biochemist. The Associate Biochemist performs stability sampling, testing, and data review for biopharmaceutical drug substance and drug products (clinical and commercial).

Key Responsibilities:
Performs stability inventory management, which includes sample coordination, aliquoting for routine testing, coordinating sample shipments, performing sample inspections, performing aseptic bulk stability fills, and performing annual inventory inspections.
Performs routine compendial testing on stability samples per SOP and GMP (visual inspection, pH, osmolality, residual moisture, subvisible particulate matter, container closure integrity).
Performs laboratory duties following all safety, cGMP, CFR and other regulations in order to assure laboratory compliance.
Performs routine laboratory duties and safety checks to ensure compliance, as assigned.
Performs stability data verification for use in stability reports, and responsible for updating stability data tables and trends, as required.
Utilizes LIMS in daily laboratory and stability operations.
Operates and maintains QC laboratory equipment/instrument per GMP, including responsibilities for installing / deactivating equipment/ instrument per GMP procedures, as assigned.
Participates in the on-call response team for chamber excursions, as assigned.
Assists in compendia methods and other analytical method qualification/validation/transfer as assigned. Writes protocols and reports as assigned.

Other Job-Related Skills:
Ability to work both individually and as part of a team with very good communication skills (verbal and written).
Strong organizational skills.
Ability to learn new methods and analyze data, including trends.

Contact information:
You may apply for this position online by selecting the Apply now button.

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Desired profile

Basic qualifications:
0 to 2 years of laboratory experience
B.S. degree in a science field required

Preferred qualifications:
B.S. degree in chemistry or biochemistry