Senior CMC Project Manager (Contract)
Late-Stage Biotechnology Company
12-Month Contract | Remote (UK & Europe)
CMC | Technical Operations | Drug Substance | Drug Product | Late Stage | NDA Readiness | CDMO Management | Pharmaceutical Development
Allerton Bishop is delighted to be partnering with an innovative late-stage biotechnology company to appoint a Senior CMC Project Manager on a 12-month contract basis.
This is an exciting opportunity to join a rapidly advancing development-stage organisation as it prepares a lead small molecule asset for late stage development, regulatory submission and future commercialisation.
Working closely with senior CMC, Technical Operations and Regulatory leaders, you will play a critical role in driving programme execution across Drug Substance, Drug Product, Supply Chain and external manufacturing activities.
The successful candidate will operate at the centre of a highly collaborative cross-functional environment, ensuring critical development milestones, manufacturing activities and regulatory deliverables are achieved on time and to the highest quality standards.
The Opportunity
As Senior CMC Project Manager, you will be responsible for coordinating and driving complex CMC programmes across internal teams, CDMOs, analytical partners and external stakeholders.
You will provide project leadership across pharmaceutical development, manufacturing, supply chain and regulatory activities whilst ensuring alignment with late stage readiness and future commercial objectives.
This role offers significant visibility across the organisation and will suit an experienced CMC professional who combines strong technical understanding with excellent programme management capabilities.
Key Responsibilities
CMC Programme Leadership
* Lead and coordinate cross-functional CMC activities supporting late stage development and commercial readiness.
* Develop and maintain integrated programme plans, critical paths, timelines and risk registers.
* Drive alignment between Technical Operations, Regulatory Affairs, Quality, Supply Chain and external manufacturing partners.
* Support governance activities and executive project reporting.
Drug Substance & Drug Product Development
* Coordinate development and manufacturing activities across Drug Substance and Drug Product programmes.
* Support process development, technology transfer and manufacturing scale-up activities.
* Monitor critical deliverables to ensure programme milestones are achieved.
CDMO & External Partner Management
* Manage relationships with CDMOs, analytical laboratories and external development partners.
* Coordinate project deliverables, timelines and issue resolution activities.
* Support technical transfer, vendor management and commercial readiness initiatives.
Regulatory & Commercial Readiness Support
* Support CMC activities associated with global regulatory submissions and registration programmes.
* Coordinate documentation, technical reports and supporting information required for regulatory filings.
* Ensure development activities align with future NDA and MAA submission requirements.
Supply Chain & Clinical Operations
* Support clinical supply planning and manufacturing scheduling activities.
* Coordinate logistics, inventory management and supply continuity programmes.
* Work closely with Clinical Operations and Supply Chain teams to ensure uninterrupted product availability.
Candidate Profile
Successful candidates are likely to come from biotechnology companies, pharmaceutical manufacturers, CDMOs or specialist development organisations.
We are particularly interested in professionals who have supported late-stage development programmes and understand the challenges associated with late stage readiness, regulatory submissions and commercial launch preparation.
Essential Experience
* Significant experience within CMC, Technical Operations, Pharmaceutical Development or Project Management.
* Experience supporting small molecule Drug Substance and/or Drug Product development programmes.
* Strong background managing CDMOs and external manufacturing partners.
* Experience operating within GMP-regulated pharmaceutical environments.
* Excellent project management, stakeholder management and communication skills.
* Ability to coordinate multiple complex workstreams simultaneously.
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