SME - MSAT EM Technical Operations DS/DP

GSK

4d•Onsite

About The Position

The Global Manufacturing Science and Technology (MSAT) organization is a network focused function which provides strategic direction, technical and operations support to ensure that GSK Global Supply Chain network goals and objectives are achieved, through a focused strategy execution. As an accountable Subject Matter Expert (SME), this role will 1) collaborate closely with internal and external stakeholders, to support the ongoing commercial manufacture of large molecule Drug substance and/or sterile Drug Product, ensuring technical lifecycle support and 2) execute MSAT/EM technical strategy and activities for manufacturing processes including routine operation, field, technical support, and validation.

Requirements

Bachelor’s degree in Pharmaceutical Sciences, Engineering, Chemistry, Biology, or a related scientific field.
5+ 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 with managing product life cycle activities.
Lead technical investigations, perform root cause analysis, manage change control, and develop corrective and preventive actions (CAPA).
Experience collaborating with external manufacturing partners.

Nice To Haves

Advanced degree (Master’s or PhD) in a relevant scientific or engineering discipline.
Demonstrated success identifying and leading continuous improvement
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.

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: CPV, Change control, Deviation investigation and resolution, CAPAs, Waste mapping, Performance of standards.
Continuous Improvement (financial, process, etc)