GSK
Small Molecule CMC Leader - Senior Director
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Small Molecule CMC Leader - Senior Director
Senior Director, Chemistry Manufacturing and Controls (CMC) Project Leadership
Position Summary
You will lead CMC (Chemistry, Manufacturing and Controls) for a Medicines Development and Innovation programme. You will lead the development, industrialisation, and lifecycle delivery of the assigned physical medicine (either small molecule, biopharmaceutical or CGT) from Commit to Phase 2 (C2P2), through the development of the Phase 3 (P3)/commercial process, the file, submission to review and launch, and the completion of the major clinical & CMC/Supply Chain (SC) lifecycle work. The role holder:
- Engages with the medicine 6 to 12 months prior to C2P2.
- Takes accountability from the initial CMC Leader at C2P2.
- Leads delivery of the P3/commercial process, clinical supplies, and filing stages.
- Ensures the successful execution of the process performance qualification (PPQ), establishing continuous process verification (CPV) and pre-approval inspection (PAI) readiness.
- Ensures global file, review, and launch readiness.
- Delivers further P3 studies and CMC/SC sub-projects.
The role holder then transitions to the MSCL (Medicine Supply Chain Leader) and subsequent lifecycle projects.
The Senior Director role focuses on projects with CMC budgets of over £30M and/or peak-year sales exceeding £500M. This position is complementary to a Director role, which oversees projects with CMC budgets under £30M and/or peak-year sales below £500M.
Key Responsibilities
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Achieve seamless transition and knowledge transfer from the pre-C2P2 period and early Medicine Development (eMDCL) through to P2 and P3/commercial process development.
- Engage with, and guide, the early CMC Medicine Development CMC Leader and team 6-12 months prior to C2P2 to:
- Prepare plans.
- Allocate resources (including adjustments to both internal and external spends for recommendations arising from C2P2).
- Be mindful that earlier planning fixation may be necessary for complex or expedited medicines.
- Define the medicines development strategy and commercial vision in collaboration with:
- Medicine Development Leader (MDL)
- Medicine Development Team (MDT)
- Engage with, and guide, the early CMC Medicine Development CMC Leader and team 6-12 months prior to C2P2 to:
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Align on CMC/SC strategic approaches, including:
- Drug substance (DS).
- Drug product (DP).
- Device.
- Analytical, manufacturing, supply chain, quality, and regulatory approaches through the CMC/SC matrix team.
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Develop options and recommendations for:
- P3 development and supply.
- Global regulatory filings, balancing time, costs, resources, and risk.
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Ensure requirements are captured in the medicine CMC/SC Master Strategy & Plan.
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Secure timely decision-making through governance (including, but not limited to, CMC Board, Development Review Board, and Portfolio Investment Board).
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Drive delivery of the strategy and plan via the CMC/SC matrix team, including:
- DS, DP, device, analytical, manufacturing.
- Supply chain, Quality Assurance (QA), regulatory, data, statistical, and project management functions.
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Maintain close coordination with:
- Research & Development (R&D).
- Global Supply Chain (GSC).
- External Contract Development and Manufacturing Organizations (CDMOs).
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Cease new scope for threshold breaches concerning:
- Timelines, costlier spends, resources, and risks.
- Governance-compliant strategies, focusing on DFW and post-approval changes for warranty and lifecycle updates.
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For P3 interventions, align processes for PPQ, PAI readiness, global commercial launch and filing, prioritising it through a CPV strategy.
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Monitor high-risk phases, focal areas that need enhanced organisational accountability to meet timelines, compliance, costs, risks and resources with multifunctional teams.
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Define post-launch medicine development needs in collaboration with:
- MDL/MDT & MSCL (Medicine Supply Chain Leader) later.
- MCL/MCT (Medicine Commercial Leader/Team), considering ** lifecycle strategies and change approval operations**.
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Work collaboratively to:
- Implement logistics and resource plans within lifetime engagement timelines.
- Manage external MSCL handover authorities to accommodate applicable programming scope.
Cross-Functional Leadership
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Act as the key medicine development and commercial voice, aligning with:
- Organisational strategic directions (including chemical, manufacturing, and supply chain aspects) at various stages of product lifecycle handling.
- Across operational alignment of cross-categorical medical functions.
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Direct operational maturity transitions phasing for the MCL, MSCL, CDMOs, including CMC, SC, projectised Review Programme and Marketing advisory guidance.
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Manage any overrides by the MCL, as informed by global sales forecasts and trigger thresholds.
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Optionally may:
- Manage subordinate MDI Directors and respective line management stakeholders.
- Curate and provide strategic due diligence support for CMC/SC functions.
- Shape Systems and process updates.
Required Qualifications & Experience
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Education and Qualifications:
- Holding a BSc or PhD in Life Sciences, (bio)chemical engineering, pharmaceutical sciences, or a related field.
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Key Experience and Skills:
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Comprehensive background in pharmaceutical, CMC, and supply chain operations.
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Director or Senior Director-Level experience, preferably in CMC within large organisations.
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Demonstrated expertise in:
- Developing, presenting, and defending P2, P3, and lifecycle CMC/Supply Chain strategies, plans, and resources to governance.
- Inguiring needs-driven Pay versions and design fit required judges – apply US, EU, Japan, and China health authority requirements.
- Managing major pharmaceutical milestones and pre- and post-approval inspection stakeholder engagements while capturing dynamics, neglect factors, Enhanced PPQs, Paเปเพ вироблять.
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Leadership in multi-disciplinary, international teams, including:
- External collaborators (CDMOs).
- Handling CMC/SC projects from P2, P3, filings & launch, progression lifecycle-wise.
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Proven track records in:
- Teaching and mentoring, encompassing matrix leadership and line management.
- Leading cross-functional teams in matricial environments.
- Deep insights into coordination, handling scaleup, and collaborative tech transfer processes.
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Hands-on CMC experience during late-stage developments for small molecule, biologics, or advanced modalities.
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Enriched knowledge of:
- Manufacturing challenges and adjustments in current market like supply logistics, pre-commercialization, financing shocks, formulation sustainability.
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Relevant regulatory experience, ensuring facets such as device submissions and marketing.
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Strong problem-solving abilities with:
- Enhanced decision-making spires, balancing technical and non-technical advice.
Work Location
This role is open to candidates who can work from either:
- Ware, United Kingdom or Upper Providence, USA under a hybrid working model.
- Combining on-site and remote work arrangements.
- Fully remote arrangements are not available.
Additional Information
No explicit "Why GSK"gründ nded HR-space details shall be applied as modified from or author’ll-guided employee statements. The aligned themes are complimentary per their published data pages.
Closing Video Link for Post:
Please note: 16th July 2026, midnight applies for applications.
Policy Reminder
Removed internal personnel access inclusion into external application route without composed agreement.
Access Policies:
For USA or internationally licensed healthcare professionals, GSK is bound to comply with the CMS Transparency in Coverage requirement details: CMS Conditions Website. Request interviews using established paths ensuring pediatric or generic considerations during evaluation. Interview Participant Requests should however not aim for this recruitment communication/enquiries unless significant.
Did you require any adjustment to fulfil and discover your successful experiences? The process can be taken via contacts: UKRecruitment.Adjustments@gsk.com. If queries do not intend adjustment queries, we recommend our FAQ section.
Fair Employment Opportunities Notice
This position adheres to effective anti-bias and equal employment laws, including compliance but not limited to:
- Proper consideration without distinguishing basis of ethnicity
- Gender, pregnancies and expression levels
- Homosexuality, transgender specifics, familial statuses
- Practiced faith orientations, visible disabilities or accommodations
- Social Movement lobbying recognition
- Math-based elements (or legality compliance with power rules)
- Pedagogic attrition affecting career bias recognition
GSK prioritises flexible working opportunities aligning with worker lifestyle needs. Our listings will periodically list non-standard agendas, initial contacts, and subsequent negotiation support solutions.
Note for Employment Forces or Agencies
Internal candidate listings are capped, ensuring refusals from any professional services outside recognized legal permits. Removal of listed requirements extends to non-pre-approval applications from external forces unless prior written endorse partnerships are signed formative or representative terms apply therein. Clarifications will remain limited to GSC and human resource realms, thus administratively re-segregated potential commitments declare determined terms pre-existing.
Core Business Objectives
Removing specific concentration areas covers claims/contexte restrictions while maintaining unambiguous area remits: CMC Lifecycle Protection.
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