Oligonucleotide Molecule Steward

Overview

This is a truly exciting opportunity for an experienced scientific professional to take end-to-end technical accountability for GSK\’s oligonucleotide portfolio, from bulk Drug Substance manufacturing, Drug Product formulation, packing and related support activities, providing strategic technical leadership to ensure successful new product introduction, quality robustness and productivity improvements across the lifecycle. The Oligonucleotide Molecule Steward is aligned to a new asset at Commit to Commercial Design with responsibility for representing MSAT in the development of the Product Control Strategy. When the product transfers to GSC accountability, the Molecule Steward coordinates Drug Substance, Drug Product, Analytical Strategy and if appropriate Device Leads to maintain the Product Control Strategy and ensure the product is maintained in the desired state of control throughout product lifecycle. You will be responsible for developing and delivering the technical elements of the GSC strategy with the GSC Strategy Lead and will be a recognised GSC expert in the oligonucleotide products. In addition to strategic technical leadership, the role will be expected to provide deep technical expertise where required to ensure highest levels of quality and robustness. Ready to shape the future of healthcare?

Responsibilities

• Representing MSAT as technical single-point accountable decision maker to CMC Matrix and Product Supply Chain teams, ensuring that a product control strategy is defined and maintained to drive a robust product that meets target manufacturability criteria.
• Responsible for defining the End-to-End Product Performance Qualification and Ongoing Continuous Verification Strategy for the product(s), including trending and sampling plans and ensuring alignment and consistency across supply nodes.
• Maintaining accountability for the product(s), from transfer from R&D throughout its lifecycle, ensuring improvement plans (including 2nd generation processes) are developed and delivered impacting the manufacturing process, analytical process, pack, device, and associated specifications to deliver value.
• Maintaining solid knowledge and understanding of complex scientific subject matter as well as evolving regulatory policies and guidelines and industry best practices. This knowledge is used in developing improvement plans for the products.
• Ensuring from an MSAT perspective that oligo platform technology strategies & specific solutions as required will appropriately support the lifecycle needs of each individual oligo product/dose form.
• Responsible for leading Product Technical Lifecycle Teams, ensuring risks are identified and mitigated and technical issues are resolved in a timely manner.
• Responsible for coordinating the review of regulatory submissions and responses to technical questions within MSAT, ensuring review by appropriate SMEs and sites.
• Providing leadership and subject matter expertise where required for investigations and/or critical deviations, troubleshooting, and major change programmes.
• Ensuring that product history and knowledge from development through lifecycle is maintained and aligns with knowledge management standards for the product(s) within the GSC network.
• Managing strong collaborations with technical staff across the Supply Chain sites, MSAT & R&D, with effective and clear communication on highly technical topics. Must be able to lead and operate in an environment with high degree of change and uncertainty.
• Uniting science, technology and talent to get ahead of disease together.

Qualifications

• University Degree (minimum) in Chemistry, Chemical engineering, Pharmaceutical Sciences or similar area
• Comprehensive knowledge of external regulatory requirements (MHRA, FDA), and internal/external quality and safety requirements
• Experienced in technology transfer, with an understanding of the product development process
• Knowledge of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7 – 12) and Product Lifecycle Management
• Demonstrated experience in the pharmaceutical industry in leading the technical aspects of Product Lifecycle Management, including supporting process investigations.

Preferred Qualifications

• Project management and prioritization skills gained within a complex matrix
• Excellent problem solver and ability to think and work creatively
• Strong technical acumen and communication skills with the ability to articulate complex, technical details to stakeholders and enable cross functional collaboration across sites, supply chain, R&D and suppliers
• Experience managing external partners/CDMO\’s in NPI and/or commercial supply
• Ability to effectively influence stakeholders at all levels

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. People and patients around the world count on the medicines and vaccines we make, so we\\\’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. 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. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK\\\’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov