Molecule Steward

Biopharma Careers; Upper Providence (Delaware County); Hybrid; USD 180,000 - 240,000; Full time

Job summary

GSK is seeking an experienced Molecule Steward to provide end-to-end technical leadership for a new asset, coordinating MSAT activities across Drug Substance, Drug Product, analytical strategy, and device leads to uphold the Product Control Strategy throughout the lifecycle.

You will represent MSAT in CMC and Medicine Supply Chain discussions, define the End-to-End Product Performance Qualification and Continuous Verification strategy, and lead Product Technical Lifecycle Teams to mitigate risks

Qualifications

• Degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar.
• Extensive experience in small molecule development and/or manufacturing.
• Knowledge of MHRA, FDA regulatory requirements and quality/safety standards.
• Experience in technology transfer and product lifecycle management.

Responsibilities

• Act as MSAT technical single-point accountable decision maker for product strategy.
• Define End-to-End Product Performance Qualification and Verification plans.
• Maintain product knowledge from development through lifecycle and drive improvements.
• Lead lifecycle teams and coordinate cross-site collaboration on technical topics.
• Support regulatory submissions and responses to technical questions within MSAT.

Skills

CMC Strategy

Data-Driven Decision Making

Data Integrity

GxP Regulations

Lean Management

Problem Solving

Process Optimization

Project Leadership

Risk Awareness

Scientific Writing

Technology Transfer

Education

Chemistry/Chemical Engineering/Pharmaceutical Sciences degree

Tools

Regulatory guidance tools

Job description

Position Summary

This is a truly exciting opportunity for an experienced scientific professional to take end-to-end technical accountability for a given product, from bulk API manufacturing, 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 Molecule Steward is aligned to a new asset at Commit to Commercial Development with responsibility for representing MSAT in the development of the Product Control Strategy. When the product transfers to GSC accountability, the Molecule Steward co-ordinates 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 Global Supply Chain strategy with the GSC Strategy Lead and will be a recognised GSC expert in the given product or dose form. 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.

Responsibilities

• Representing MSAT as technical single-point accountable decision maker to CMC Matrix and Medicine 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, including trending and sampling plans and ensuring alignment and consistency across supply nodes.


• Maintaining accountability for the product, 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.


• Accountable from an MSAT perspective for defining technology strategy & specific solutions as required to support the overall product or dose form lifecycle.


• 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 programs.


• Ensuring that product history and knowledge from development through lifecycle is maintained and aligns with knowledge management standards for the product or dose form 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.

Basic Qualifications

• University Degree (minimum) in Chemistry, Chemical engineering, Pharmaceutical Sciences or similar area


• Extensive years’ experience in small molecule pharmaceutical development and/or manufacturing


• 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, Q8, Q9, Q10) 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

Work Location

This role can be based in Ware, Worthing, Barnard Castle, UK; or Upper Providence or Durham, USA and offers a hybrid working model, combining on-site and remote work.

Skills

CMC Strategy, Data-Driven Decision Making, Data Integrity, Debate Moderation, Digital Fluency, GxP Regulations, Lean Management, Problem Solving, Process Optimization, Project Leadership, Risk Awareness, Scientific Writing, Technology Transfer

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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.

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.

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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.