CMC Manager

Barrington James; Milano; Ibrido; EUR 60.000 - 110.000; Tempo pieno

Descrizione del lavoro

Barrington James is seeking an experienced CMC Manager in Italy to lead Chemistry, Manufacturing and Controls across development programmes. This role combines strategic oversight with hands-on management of external development and manufacturing activities in a biotech setting.

The successful candidate will drive CMC strategy, ensure regulatory alignment with FDA/EMA guidelines, and oversee collaboration with cross-functional teams to progress assets through clinical development and regulatory

Competenze

• 8–10 years of experience in CMC development and manufacturing.
• Experience managing outsourced CMC activities with external partners (GMP).
• Knowledge of FDA, EMA, and ICH CMC requirements.
• Strong project management and stakeholder management skills.

Mansioni

• Lead and coordinate CMC activities across development programmes and external manufacturing.
• Oversee drug substance and drug product manufacturing and stability programmes.
• Manage relationships with external CDMO/CMO partners and ensure timely delivery of materials.
• Provide CMC input to regulatory strategy and documentation.

Conoscenze

CMC strategy

Regulatory affairs

Project management

Cross-functional collaboration

Vendor management

Formazione

Master’s or PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences or related field

Descrizione del lavoro

Location: Italy (Hybrid working options available)

Salary Range: €60,000 – €110,000 (dependent on experience)

About the Opportunity

We are supporting a growing, innovative biotechnology company developing next-generation therapies within a specialist therapeutic area. As the company continues to advance its pipeline through clinical development, they are seeking an experienced CMC Manager to lead Chemistry, Manufacturing and Controls activities across their development programmes.

This is an exciting opportunity for a CMC professional who enjoys working in a dynamic biotech environment, combining strategic oversight with hands‑on management of external development and manufacturing activities. The successful candidate will play a key role in ensuring the successful progression of assets from development through clinical supply and regulatory milestones.

Position Summary

The CMC Manager will be responsible for overseeing CMC activities related to pharmaceutical development, manufacturing, and regulatory support. This role will provide technical leadership across analytical development, formulation, process development, and external manufacturing activities, ensuring delivery of high-quality drug substances and drug products in line with regulatory expectations.

Working closely with internal cross‑functional teams and external partners, the CMC Manager will support the development strategy of clinical‑stage programmes while ensuring compliance with global regulatory requirements, including FDA and EMA guidelines.

Key Responsibilities

• Lead and coordinate CMC activities supporting pharmaceutical development and clinical programmes, including:
• Drug substance and drug product manufacturing
• Stability programmes and lifecycle activities
• Manage relationships with external CDMO/CMO partners, ensuring timely delivery of high‑quality materials for preclinical and clinical studies.
• Provide technical oversight and strategic input into CMC development plans, working collaboratively with cross‑functional teams including:
• Regulatory affairs
• Quality
• Intellectual property teams
• Support the selection, qualification, and management of external vendors and manufacturing partners.
• Ensure CMC activities align with global regulatory expectations, including FDA, EMA, and applicable ICH guidelines.
• Support preparation and review of regulatory documentation, including CMC sections for clinical trial applications and marketing submissions.
• Provide CMC expertise during interactions with regulatory authorities, including preparation for key development milestones and regulatory meetings.
• Monitor industry trends, scientific advances, and regulatory developments relevant to pharmaceutical development and manufacturing.
• Provide CMC input into intellectual property strategy and technical documentation.
• Manage project timelines, budgets, risks, and deliverables associated with outsourced CMC activities.

Candidate Profile

The ideal candidate will have a strong background in pharmaceutical development and CMC strategy, with experience working within biotech, pharmaceutical, or a highly innovative drug development environment.

Required Experience

• Master’s degree or PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline.
• Minimum 8–10 years of experience in CMC development and manufacturing within the pharmaceutical or biotechnology industry.
• Proven experience managing outsourced CMC activities with external partners, including:
• GMP manufacturing activities
• Strong understanding of the drug development lifecycle, from early development through clinical supply and regulatory submission.
• Experience supporting regulatory documentation, including IND, NDA, MAA, CTA, or equivalent submissions.
• Knowledge of FDA, EMA, and ICH regulatory requirements related to CMC.
• Experience supporting regulatory interactions, including late‑stage development discussions and CMC meetings with health authorities.
• Strong project management skills with the ability to manage external suppliers, budgets, timelines, and technical deliverables.
• Excellent communication and stakeholder management skills, with the ability to collaborate effectively across multidisciplinary teams.

Preferred Experience

• Experience within CNS, neuroscience, or other specialised therapeutic areas.
• Experience working within a virtual biotech or outsourced development model.
• Experience managing CDMO relationships across international markets.

Why Join?

This is an opportunity to join a growing biotech organisation where you will have significant ownership of CMC strategy and external manufacturing activities. The role offers exposure across the full development lifecycle and the chance to directly contribute to advancing innovative therapies towards clinical and regulatory milestones.