Responsibilities
* Execute technical strategy and represent MSAT Technical Operations for External Manufacturing in relevant PQTS teams
* Ensure support for CMOs in establishing maintenance, performance of standards, and technical transfers of established products or transfers between CMOs
* Support CMO for audit documentation, inspection readiness, and prepare local teams during audits
* Ensure critical lifecycle activities:
o CPV
o Change control
o Deviation investigation and resolution
o CAPAs
o Waste mapping
o Performance of standards
o Continuous Improvement (financial, process, etc)
Basic Qualification
* Bachelor's degree in Pharmaceutical Sciences, Engineering, Chemistry, Biology, or a related scientific field.
* 7+ years' experience in drug substance and/or drug product (including device) technical operations in pharmaceutical or biologics manufacturing.
* Experience of the pharmaceutical current best practice in analytical and manufacturing technologies, validation and GMP compliance.
* Experience identifying and leading continuous improvement.
* Lead technical investigations, perform root cause analysis, manage change control, and develop corrective and preventive actions (CAPA).
* Experience collaborating with external manufacturing partners.
Preferred Qualification
* Advanced degree (Master's or PhD) in a relevant scientific or engineering discipline.
* Certification or formal training in project management, risk management, or continuous improvement methods (for example Lean or Six Sigma).
* Experience supporting regulatory inspections and preparing technical responses.
* Proven track record of successful technology transfers to CMOs or external partners.
* Experience coaching and developing technical capability across multi-site or global teams.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at usrecruitment.adjustments@gsk.com.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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