+ Requisition ID:WD98233
+ Position:Full time
+ Open date:Nov 9, 2016 6:57 PM
+ Functional area:Quality
+ Location:Maryland
+ + Required degrees:Bachelors
+ Experience required:4 years
+ Relocation:No
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Basic qualifications:Bachelor of Science degree with at least 4 years of experience in biopharmaceutical assay development and quality control environment or MS with at least 2 years of experience in biopharmaceutical assay development and quality control environment
Preferred qualifications:n/a
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 a Biochemist. In this role, you will perform quality sampling, testing, and data review for in-process biopharmaceutical materials, active biopharmaceutical ingredients and finished bulk drug substance.
Key Responsibilities
? Coordinate routine in-process biopharmaceutical materials, bulk biopharmaceutical ingredient, finished biopharmaceutical product and sample testing with testing labs.
? Conduct, documents and review (as needed) routine compendia release samples per SOP.
? Train new analysts for compendia and other analytical test methods per training plans as needed.
? Operate and maintain QC laboratory equipment/instrument in a cGMP-compliant manner.
? Advanced knowledge in cGMP, CFR and other regulations in order to assure laboratory compliance.
? 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, and testing data. Trend analytical results as needed.
? Lead investigation and assay trouble shooting. Strong interpersonal skills (ability to work in a team environment).
? Lead compendia methods and other analytical method qualification/validation/transfer. Write and/or review protocols and reports.
? Attend weekly meetings to support ongoing and new campaigns.
? Communicate with multiple departments routinely: QA, Project Leads, Materials Management, Analytical testing groups, Regulatory, and Facilities
? Revise product specifications and perform system change procedures. Advanced knowledge working in quality systems: SAP and LIMS based systems
? 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/ AgenciesGSK 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 ReportingFor the Recordsite. 5bdfdfbbba8f49f6a3aac95e3b8b8175

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