MSAT Drug Product Lead
$125.25k - $208.75kGlaxosmithkline
Position Summary Manage the Manufacturing Science and Technology (MSAT) Drug Product technical delivery for drug product manufacturing of a defined product or product family, focusing on New Product Introduction (NPI) and successful product launches. Lead key activities to deliver right‑first‑time qualification and establish robust product control strategies across manufacturing sites. Responsibilities Act as the single technical point of contact for the drug product portfolio, owning technical risk, decision‑making and product knowledge. Lead and deliver technology transfers to internal sites and external manufacturers, including transfer packages, training and readiness reviews. Manage continued process verification, process performance qualification and change management to maintain product robustness and compliance. Drive right‑first‑time execution of product qualification activities (e.g., PPQ/qualification readiness), managing governance through stage‑gate forums. Define and maintain product control strategy and technical risk assessments, and translate this knowledge into clear documentation for operations. Support regulatory submissions and post‑approval inspections by providing technical input, comparability strategies and supporting documentation. Manage cross‑functional investigations, root‑cause analysis and corrective actions for complex deviations and quality events. Qualifications Basic Qualification Bachelor’s degree in a relevant scientific, engineering or technical discipline. Minimum 10 years’ experience in pharmaceutical development, manufacturing or MSAT roles. Demonstrated experience in technology transfer, process validation and product lifecycle technical leadership. Practical knowledge of Good Manufacturing Practice (GMP) and regulatory expectations for drug product manufacture. Experience applying risk assessment approaches, process control strategies and quality tools to maintain product performance. Familiarity with regulatory dossiers and supporting health authority questions. Strong written and verbal communication skills and experience working with multi‑disciplinary teams. Hands‑on experience with oral solid dose drug product manufacturing. Preferred Qualification Advanced degree (MSc, PhD) in a relevant scientific or engineering discipline. Experience with Quality by Design, continued process verification and statistical process control. Track record of leading complex technical investigations and delivering sustainable corrective actions. Experience supporting regulatory filings, inspections and readiness activities. Ability to lead improvement projects that demonstrate measurable technical or operational value. Work Arrangement This role is hybrid. The employee will be expected to visit manufacturing sites as required and spend regular time on site. Fully remote or permanent home‑working arrangements are not available. Compensation & Benefits US annual base salary ranges from 125,250 to 208,750 dollars. The role includes an annual bonus and eligibility to participate in a share‑based long‑term incentive program depending on the level of the role. Benefits include health care and other insurance benefits for employee and family, retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. Equal Opportunity Employer GSK is an Equal Opportunity Employer. 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, military service or any other characteristic prohibited under federal, state or local law. #J-18808-Ljbffr GlaxoSmithKline
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