Scientific Leader

GSK•Upper Providence, PA

5d•Onsite

About The Position

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D Drug Development and Supply (DDS) is a highly experienced Chemistry, Manufacturing and Controls (CMC) organization accountable for delivering robust, cost effective and competitive products and manufacturing processes spanning the full life-cycle of asset development from discovery through to commercialization. Analytical Development (AD) is a key technical department within DDS who are accountable for ensuring all analytical deliverables are met to ensure the progression of GSK’s pipeline. These activities are delivered through state-of-the-art internal facilities as well as strategic external partners. We pioneer innovative technologies to improve robustness, reduce cost of goods, and improve the patient experience. Position Summary As a Scientific Leader in the Analytical Projects-US department, within AD, you will be a member of a highly skilled team of scientists responsible for the development, validation, and implementation of various analytical methods and state-of-the art analytical technologies. You will lead efforts to develop methods that focus on product quality and process-specific analytes and support various aspects of small molecule, mAb and/or Antibody Drug Conjugate (ADC) process development and manufacturing. You will be involved in all aspects of pharmaceutical development, including engagement with CMC project teams and other stakeholders for various projects in different stages of development. As a Scientific Leader, you will oversee and be involved with the development, validation, and transfer of analytical methods that employ such techniques as HPLC, dissolution, UV, CAD and MS. This role requires excellent verbal and written communication skills, impeccable organization, and broad scientific knowledge. Because the role will require both collaborative and independent work, the ideal candidate will also possess good interpersonal skills, an open mindset, and the capacity for self-motivation. You will apply deep technical expertise in analytical development to support both early‑ and late‑phase assets, including method lifecycle management, product characterization, and the introduction of state‑of‑the‑art analytical technologies. You may also share this expertise across large molecule and small molecule modalities supported by the department.

Requirements

Bachelor’s degree in a scientific or technical field such as biology, chemistry, biochemistry, or engineering.
10+ years of experience (or 7+ years with a PhD) in biopharmaceutical or biotechnology development or manufacturing.
Experience working with cross functional teams in global or geographically diverse environments, and experience performing matrix and project management tasks.
Experience using analytical separations methods, including HPLC, uHPLC and GC with standard and alternative detection modes such as UV, FLD, CAD, MS and ELSD.
Experience developing and validating analytical methods according to pharmacopeial requirements and lifecycle management standards.
Experience in analytical or process method development and validation.
Experience applying Good Manufacturing Practice (GMP) requirements and regulatory standards relevant to pharmaceutical product development, including scale up and technology transfer activities.
Experience creating and delivering written and verbal communications for organizational or technical documentation purposes.
Strong written and verbal communication skills, and experience documenting experimental plans and results.

Nice To Haves

Advanced degree (MS or PhD) in a relevant scientific discipline.
Experience working on, or leading, ADC analytical activities.
Experience working with external partners, including contract research organizations (CROs) or contract development manufacturing organizations (CDMOs).
Proven experience in technology transfer, either across internal sites or to external partners.
Contributions to regulatory submissions and preparation of technical reports.
Demonstrated track record of implementing process improvements or digital solutions that enhance quality, efficiency, or operational performance

Responsibilities

Be a key member, or leader, of matrix analytical teams in the early or late small molecule, mAb and/or ADC development phase. Ensuring that analytical methods, control strategies, and GMP release and stability deliverables are advanced to ensure project pipeline progression.
Serve as a departmental expert in key analytical techniques—leading troubleshooting, enabling innovation, and integrating new technologies to support program and organizational goals.
Be involved in GMP compliance activities, including instrument qualification, deviation management, and change control processes.
Drive standardization and best practices across analytical platforms to enhance harmonization, operational efficiency, and quality.
Act as a subject matter expert during regulatory inspections, GMP audits, and agency interactions, effectively representing analytical strategy, methods, and supporting data.
Author and review high‑quality documentation, including scientific papers, patents, regulatory submissions, CQAs, and specifications, ensuring scientific rigor and clarity.
Author regulatory submissions (IND/IMPD through to NDA/MAA).
Perform complex data analysis and interpretation to support decision‑making for both drug substance and drug product development.
Collaborate cross‑functionally with R&D, Global Supply Chain (GSC), and external partners to resolve analytical challenges and ensure seamless program progression.
Be a mentor to less experienced staff and share your experiences.
Oversee method and process development activities, including qualification, validation, technical transfer, and continuous improvement initiatives, with strong documentation and knowledge‑sharing practices.