CMC Project Manager - Late Stage Biologics

BioTalent; München; Vor Ort; EUR 80.000 - 120.000; Vollzeit

Zusammenfassung

A biotechnology firm in Munich is seeking an experienced CMC Project Manager to oversee project management in late-stage biologics. The role involves cross-functional coordination, timeline management, and ensuring regulatory compliance. Candidates should have a master's degree, 8+ years of experience in CMC, and strong communication skills. Knowledge of GMP and drug development is essential.

Qualifikationen

• 8+ years of CMC experience in pharma/biotech.
• 5+ years in project management.
• Excellent communicator with strong leadership skills.

Aufgaben

• Own CMC project planning for clinical stages.
• Coordinate timelines and deliverables across teams.
• Ensure GMP and regulatory alignment in development.

Kenntnisse

Project management

GMP knowledge

Regulatory compliance

Communication skills

Organizational skills

Ausbildung

Master’s degree in chemistry or biotech

Jobbeschreibung

CMC Project Manager – Late-Stage Biologics (Germany-Based)

Munich, Germany - on-site

BioTalent is partnering with a next-generation oncology biotech developing clinical-stage ADCs to transform cancer treatment. With proprietary technology platforms, a robust pipeline, and bold global ambitions, they are rapidly becoming a leader in targeted therapeutics.

They’re hiring a CMC Project Manager to lead cross-functional coordination of Chemistry, Manufacturing & Controls (CMC) activities across a growing portfolio. The role will drive clinical manufacturing strategy, supply chain alignment, and project execution from pre-IND through to late-stage development, acting as a key bridge between internal functions and CDMO partners.

Key Responsibilities :

• Own CMC project planning for programs moving through clinical stages
• Coordinate timelines, deliverables, and risks across internal teams and CMOs
• Maintain detailed project documentation and provide regular leadership updates
• Track and manage budgets, invoicing, and vendor activities
• Ensure GMP and regulatory alignment across global development programs
• Drive accountability across internal stakeholders and external partners

Candidate Profile :

Master’s degree or higher in chemistry, biotech, or related field

8+ years of CMC experience in pharma / biotech, including 5+ years in project management

Strong knowledge of GMP, regulatory expectations (FDA / EMA), and drug development

Experience managing CDMOs and working across clinical-stage pipelines

Excellent communicator with strong organisational and leadership skills

Fluent in English, based in Germany (local address required)

Bonus if you bring :

PMP certification

Experience in ADCs or biologics

Background in IND / IMPD submissions

Budgeting and supply chain familiarity