Molecule Steward Lead - Molecules
King of Prussia, Montgomery County, Pennsylvania, 19406, USA
Listed on 2026-07-07
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Business
Regulatory Compliance Specialist
Position Summary
You will lead molecule stewardship for small molecule programs across development and manufacturing. You will partner with discovery, process development, analytics, regulatory, manufacturing and external suppliers. We value collaborative leaders who make clear technical decisions, care for quality, and focus on patient impact. This role offers visible influence across program life cycles, strong growth opportunities, and the chance to help GSK unite science, technology and talent to get ahead of disease together.
- Lead technical stewardship for a portfolio of small molecule programs from candidate selection through commercial lifecycle.
- Define and maintain product control strategies, lifecycle plans and technical deliverables.
- Coordinate cross-functional teams on technology transfers, process performance qualification, and ongoing process verification.
- Oversee technical risk assessments and deliver mitigation plans for quality, supply and regulatory readiness.
- Provide hands‑on technical leadership for investigations, troubleshooting and major change programs across sites and suppliers.
- Mentor and develop the molecule stewardship team and build strong relationships across the network.
- Own end‑to‑end technical strategy and decision points for assigned small molecule assets.
- Translate scientific and analytical data into clear, actionable guidance for program teams and stakeholders.
- Ensure data integrity, documentation and evidence support for regulatory submissions and inspections.
- Drive alignment across sites, contract manufacturers and internal teams to ensure consistent product performance.
- Lead Product Technical Lifecycle Team activities and yearly robustness reviews to identify and resolve risks.
- Share best practices for characterization, stability strategies and analytical approaches to improve product robustness.
This role is based in the United States and offered as a hybrid role. You will combine on‑site collaboration with flexible remote working to meet team and program needs. You will work in a fast‑paced, collaborative environment where your technical leadership will shape program outcomes. We welcome people who are accountable, inclusive and focused on delivering quality for patients.
Basic Qualification- Bachelor's degree in chemistry, pharmaceutical sciences, chemical engineering or related field. Advanced degree preferred.
- At least 8 years' experience in small molecule development, analytical development, process development or related area.
- Demonstrated experience in molecule stewardship, technology transfer or product lifecycle management for small molecules.
- Experience leading cross‑functional teams and making technical decisions in a matrix environment.
- Knowledge of global regulatory expectations for pharmaceutical development, manufacturing and quality.
- Experience managing technical aspects of investigations, deviations and corrective actions.
- Master's or PhD in a relevant discipline.
- Direct experience with technology transfer to multiple sites and with contract manufacturing organizations.
- Experience designing stability programs and analytical characterization strategies for small molecules.
- Familiarity with risk‑based approaches and project management tools.
- Proven track record developing technical talent and leading diverse teams.
- Comfortable working across time zones and with cross‑cultural, matrixed teams.
If this role feels like a fit, please apply and tell us how your experience will help move safe, effective small molecule medicines forward. We look forward to hearing from you.
The US annual base salary for new hires in this position ranges from $200,250 to $333,750. 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.
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.
If you require an accommodation or assistance, please contact the appropriate Recruitment Staff by emailing us at usre
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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