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
Drug Substance & Drug Product Development
CDMO & External Partner Management
Regulatory & Commercial Readiness Support
Supply Chain & Clinical Operations
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
SEO Keywords
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