Essential functions include planning and prioritizing resource allocation in Upper Merion Biopharm quality control biochemistry laboratory to meet testing requirements for product release and stability programs. Oversee the operation of QC Biochemistry area which includes bioassay, separations and immunoassay testing areas. Responsible for training quality control analysts, transferring assays from the development group, qualifying and validating new assays and implementing assays to be used for quality control purposes to support manufacturing and marketing of the product. Other functions: conduct laboratory investigations related to product testing, compile reports in support of product filings with the regulatory agencies. Review and release of test results, and ensure full cGMP compliance in the laboratory operations. Prepare documents (IND, BLA and MAA) to support regulatory filing.
• Responsible for training quality control analysts, transfer assays from development group, qualify and validate new assays and implement assays to be used for quality control purposes to support manufacturing and commercial products.
• Work directly with other QC groups to ensure timelines are met for release, technical transfers, stability and in-process testing.
• Conduct laboratory investigations related to product testing.
• Compile reports in support of product filings with the regulatory agency.
• Review and release of test results.
• Ensure group compliance with laws, regulations, guidelines, procedures and practices governing bioassay QC testing, including departmental and corporate standard operating procedures and safety procedures
• Ensure technical and professional growth of QC analysts, encouraging excellence and continuous improvement in their performance
• Collaborate and work effectively within the Quality Control groups as well as other departments.
• Represent the quality control department and departmental functions on company projects/committees. Review, update regulatory documents (IND, EOP2, IMPD), as required.
• Good statistical analysis, analytical and trouble shooting skills and effective multi-tasking skills.
• Must have excellent technical writing skills and high attention to detail
• Knowledge in cGMP, CFR and other regulations in order to assure laboratory compliance.
• Able to seek additional tasks or non-routine functions and accomplish them with minimal supervision.
• Overcome conflicts with priorities; consult supervisor regarding major conflicts.
• Have knowledge of cell-based or analytical assays performed in a cGMP environment.
• Have knowledge of assay transfer, validation and implementation.
• Enthusiasm to identify and evaluate new assays and new technology in improving proficiency in laboratory operations. Exceptional OE skills.
• Strong organizational skills in record keeping, data analysis, and strong computer skills.
• Good verbal and written communication ability and team oriented with strong interpersonal skills.
• Have ability to plan budget for the group
• B.S. with 12+ years, M.S. with 10+ years or PhD, with 6+ years industrial experience in biopharmaceutical industry, in Biology, Biochemistry, Analytical Chemistry or a related field, particularly in the area of assessing product activities of biological products
• 5+ years of supervisory and managerial experience.
• 6+ years of supervisory and managerial experience
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.
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 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.
Back to top