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Androlabs

Global men's health-focused pharmaceutical company

CMC Associate Director

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeLondon, UK£85k - £108k

About the Job

Requirements

  • 10–14 years in pharmaceutical manufacturing, technology transfer, and/or product development, with personal end-to-end ownership of multiple CMC programmes.
  • Direct CDMO management experience, including commercial negotiation, technical oversight, and performance management.
  • A strong scientific foundation, including the ability to read, interpret, and challenge batch records, validation reports, stability data, and analytical methods; the role is not purely project management.
  • Solid GMP knowledge and experience understanding how manufacturing changes interact with regulatory variation requirements.
  • Experience contributing to CMC sections of regulatory dossiers and understanding what a variation means and what is required to support one.
  • Budget management experience, including owning and managing project-level spend against actuals.

Responsibilities

  • Deliver CMC and development projects on time and to specification.
  • Manage a CDMO network to consistently high technical and commercial standards.
  • Keep CMC strategy integrated into regulatory, clinical, and commercial planning from the start of every programme.
  • Lead product development and redevelopment from brief to GMP readiness, including formulation, process development, and analytical method development.
  • Own technology transfers end to end, from procurement and CDMO selection through process validation and regulatory approval.
  • Define and execute comparability strategies that satisfy internal quality requirements and regulatory variation standards.
  • Drive manufacturing process improvement to enhance efficiency, cost, quality, and supply reliability.
  • Develop CMC strategies in collaboration with regulatory, clinical, and commercial teams, and provide CMC technical input into regulatory submissions.
  • Own the CMC project portfolio, maintaining a live view of status, risks, dependencies, timelines, and budgets across active programmes.
  • Manage the CMC budget by forecasting project costs, approving spend, and reporting to leadership.
  • Source, qualify, and onboard CDMOs and technical partners; negotiate commercial terms and execute agreements.
  • Own the CDMO risk register and ongoing performance management.
  • Build and maintain a trusted network of specialist CMC contractors and consultants for project-specific expertise.

Desired Qualifications

  • Experience with semi-solid or transdermal formulations, such as gels, creams, or ointments.
  • Experience with new chemical entities manufacturing.
  • Familiarity with the MAH model and its regulatory obligations.
  • Experience in a small or mid-size specialty pharmaceutical environment with high autonomy.
  • A track record of dual-sourcing or competitive CDMO selection and technology transfer programmes.
  • Experience conducting or overseeing comparability and process validation studies firsthand.

About the Company

Androlabs

Global men's health-focused pharmaceutical company

Androlabs is a global pharmaceutical company focused on men’s health. It develops and sells testosterone replacement and erectile dysfunction medications, aiming to reduce the life expectancy gap between men and women. Beyond products, Androlabs builds an inclusive community for men, addressing knowledge gaps and overlooked health issues, and encourages openness about vulnerability. The company operates in over 20 countries in Europe and Australia and works with healthcare professionals to improve men’s health outcomes. It belongs to the same corporate group as Simple Pharma and seeks new partners who share a passion for men’s health. Its goal is to extend healthy, active lives for men by providing targeted therapies and support, while challenging stereotypes and facilitating better care for men across multiple markets.

Company size
11-50
Company stage
Not listed
Total funding
Not listed
Headquarters
London, United Kingdom
Founded
2022

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