MSAT Drug Product Lead (Associate Director level)

About the role

You will manage the Manufacturing Science and Technology (MSAT) Drug Product technical delivery for drug product manufacturing of a defined product or product family with a primary focus on New Product Introduction (NPI) and successful product launches, including delivering successful right-first-time product qualifications. You will work with cross-functional teams across functions to ensure robust product control strategies are implemented at 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 appropriate governance through the relevant stage-gate forums as the program approaches PPQ, ensuring robust data, clear acceptance criteria and effective issue resolution.
• Define and maintain product control strategy and technical risk assessments. Translate that 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

• 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.
• 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 Qualifications

• 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. You 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.

How to Apply

We welcome applications from people with diverse backgrounds and experiences. If this role aligns with your skills and career goals, please apply. Tell us how your experience would help the team and what you hope to achieve at GSK. We look forward to hearing from you.

Pay

The US annual base salary for new hires in this position ranges from $125,250 to $208,750. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role.

Benefits

Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

Why GSK?

Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

Contact Information

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