Quality Control - Biochemist

Basic qualifications:

B.S/B.A in Chemistry, Biochemistry, Immunology, Molecular Biology or other science field

High volume of testing, requires a new hire to train fast and work with little supervision during testing.

Preferred qualifications:

Proficient in analytical instrument and methods, such as HPLC, spectrophotometer, Capillary electrophoresis, etc

Advanced knowledge in cGMP, CFR and other regulations in order to assure laboratory compliance.

Details:

Job Description Summary-

The Biochemist performs quality sampling, testing, and data review for in-process biopharmaceutical materials, active biopharmaceutical ingredients and finished bulk drug substance.

Job Description-

Coordinate routine in-process biopharmaceutical materials, bulk biopharmaceutical ingredient, finished biopharmaceutical product and stability sample testing with testing labs.

Conduct, documents and review (as needed) routine compendial, chemistry, immunology and molecular biology analytical testing for in-process, release and stability samples per SOP.

Train new analysts for analytical test methods per training plans as needed.

Operate and maintain QC laboratory equipment/instrument in a cGMP-compliant manner.

Evaluate laboratory SOPs and recommend improvement opportunities to maintain compliance with corporate and regulatory guidelines. Develop and/or revise laboratory SOPs as required. Must have good technical writing skills and high attention to detail.

Use QLIMS and SAP as a tool to track laboratory reagents, samples, testing data. Trend analytical results as needed.

Lead in investigation and assay trouble shooting. Advanced knowledge of analytical instrumentation and methods with strong technical and interpersonal skills (ability to work in a team environment).

Lead in compendia methods and other analytical method qualification/validation/transfer. Write and/or review protocols and reports.

Compile reports and trend assay data.

Trained as an L1 Auditor and participate in >25% of department's L1 Inspections.

Contact information:

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

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.


Meet Some of GlaxoSmithKline's Employees

Jasdeep

Procurement Associate

Jasdeep finds diverse suppliers to build GSK’s pipeline. He organizes joint ventures with companies and negotiates pricing rates and payments to build a seamless supply system for GSK’s materials and products.

Andrea

HR Associate, Future Leaders Program

Now in her second rotation of GSK’s Human Resources Future Leaders Programme, Andrea is shaping the future of talent management within Research and Development, from workforce assessments to strategy and operations.


Back to top