CMC Team Lead

Discover International; München; Vor Ort; EUR 120.000 - 160.000; Vollzeit

Zusammenfassung

Discover International in Munich is seeking an experienced CMC Team Lead to oversee Chemistry, Manufacturing and Controls activities across the full drug development lifecycle, from early development through to late-stage clinical development and commercial readiness. The role requires leading CMC strategy, providing technical and regulatory leadership, and working cross-functionally to ensure successful regulatory submissions for European and US markets.

Fluent German and English are essential.

Qualifikationen

• Significant experience leading CMC activities in pharma.
• Proven track record preparing regulatory CMC submissions for EU/US.
• Experience managing external CDMOs and CROs.

Aufgaben

• Lead and drive CMC strategy across small molecule programmes.
• Oversee drug substance and drug product development and manufacturing.
• Coordinate regulatory submissions for EU and FDA markets (IND/IMPD/NDA).
• Ensure GMP compliance and quality systems across development.
• Manage external manufacturing partners and CDMOs.
• Provide SME guidance to stakeholders and senior management.
• Collaborate with Regulatory Affairs, Quality and Clinical Development to mitigate risks.

Kenntnisse

CMC leadership

Regulatory submissions

Cross-functional collaboration

GMP knowledge

Strategic planning

Risk management

Ausbildung

Chemistry/PharmSci degree

Jobbeschreibung

Industry: Pharmaceutical / Biopharmaceutical

Language Requirements: German and English

The Opportunity

We are partnering with an innovative pharmaceutical company based in Munich to appoint an experienced CMC Team Lead to oversee and drive Chemistry, Manufacturing and Controls (CMC) activities across the full drug development lifecycle, from early-stage development through to late-phase clinical development and commercial readiness.

This is an exciting opportunity for an experienced CMC professional to take ownership of CMC strategy, provide technical and regulatory leadership, and work cross-functionally to ensure successful development and regulatory submissions across European and US markets.

Key Responsibilities

• Lead and oversee CMC strategy and activities across small molecule development programmes, from early-stage through to late-phase development.
• Drive CMC development plans, ensuring alignment with clinical development timelines and regulatory requirements.
• Lead the preparation, review and submission of CMC documentation for EU and FDA regulatory submissions, including IND, IMPD and NDA/MAA-related activities.
• Provide oversight of drug substance and drug product development, manufacturing, process optimisation, analytical development and quality activities.
• Manage and coordinate external CDMOs, CROs and manufacturing partners, ensuring technical delivery and compliance with GMP requirements.
• Act as the CMC subject matter expert, providing strategic guidance to internal stakeholders and senior management.
• Collaborate closely with Regulatory Affairs, Quality, Clinical Development and external manufacturing partners.
• Identify and mitigate CMC-related risks throughout the product development lifecycle.

Key Requirements

• Degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering or a related scientific discipline.
• Significant experience in CMC within the pharmaceutical industry, ideally within small molecule drug development.
• Proven experience overseeing CMC activities across multiple development phases, from early-stage through to late-stage clinical development.
• Strong understanding of both drug substance and drug product development and manufacturing.
• Demonstrable experience preparing and supporting regulatory CMC submissions for both European and US markets, including EU and FDA requirements.
• Experience working with CDMOs and external manufacturing partners.
• Ability to lead cross-functional teams and manage complex CMC development programmes.
• Fluent German and English communication skills are essential.

The Opportunity

This is an excellent opportunity to join an ambitious pharmaceutical organisation in Munich, taking a leading role in shaping and delivering CMC strategy across its small molecule development portfolio.

The successful candidate will have the opportunity to combine hands‑on technical expertise with strategic leadership, influencing programmes from early development through to late-stage clinical milestones.