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Cmc regulatory manager

Cambridge
Apsida Life Science
Manager
Posted: 12 June
Offer description

Title: CMC Manager

Location: United Kingdom

Duration: 12-month contract (100% attendance)


Company Overview


Apsida Life Science is currently partnering with a clinical-stage biotechnology company that is developing a potent, selective, and orally bioavailable small-molecule.


Responsibilities


* Support overall CMC program execution for Phase 3 readiness and commercial planning activities
* Develop and maintain integrated CMC timelines, project plans, risk registers, and action trackers
* Coordinate cross-functional meetings with internal stakeholders and external partners
* Track project deliverables and ensure alignment with regulatory and clinical milestones
* Prepare meeting agendas, minutes, and follow-up actions for governance and technical meetings
* Support inspection readiness and due diligence activities as needed
* Budget & Financial Tracking
* Manage and track CMC-related budgets, purchase orders, invoices, and accruals
* Monitor spending against forecasts and support annual budgeting exercises
* Coordinate with Finance and external vendors to ensure timely processing of contracts and invoices
* Assist with vendor selection and management activities


Clinical Supply & Logistics


* Coordinate clinical supply manufacturing schedules, supply of raw materials and shipping logistics
* Manage shipment planning for drug substance, drug product, reference standards, and critical materials
* Work with Supply Chain and Clinical Operations to support global clinical trial requirements and commercial supply planning
* Ensure appropriate documentation for import/export, temperature monitoring, chain of custody, and GMP compliance
* Support inventory tracking and reconciliation activities


Qualifications


* Bachelor’s degree in chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or related discipline
* 5+ years of experience in CMC, Technical Operations, Manufacturing, Supply Chain, or Pharmaceutical Project Management
* Experience supporting clinical-stage small molecules
* Demonstrated experience managing external CDMOs and cross-functional projects
* Strong organisational and project management skills with the ability to manage multiple priorities simultaneously
* Familiarity with GMP regulations and pharmaceutical development processes
* Excellent communication and interpersonal skills
* Proficiency with Microsoft Office, project management tools, and budget tracking systems


If you are interested in learning more, please reach out to Sweetness Zono at Apsida Life Science:

www.apsida.co.uk

+44 (0) 744 134 2281


Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost-effective and trusted recruitment service that puts the candidate journey at the heart of the recruitment process

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