CMC Development Manager – Oncology – Home-Based Position

Proclinical Staffing; Deutschland; Remote; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

A leading staffing firm in life sciences is seeking a specialist to manage CMC documentation for injectable products. You will work closely with R&D and external manufacturing partners to ensure high-quality and compliant processes. Ideal candidates hold a life-science degree with hands-on CMC experience. This role offers a fantastic work-life balance with 95% remote flexibility.

Qualifikationen

• Experience in writing CMC Technical Documentation (Modules 2.3 and 3).
• Hands-on experience in process development and validation.
• Expertise in managing technology transfer activities with CDMOs.

Aufgaben

• Independently author and manage CMC documentation.
• Lead process development and manufacturing workflows.
• Collaborate with R&D and Quality teams to optimize processes.

Kenntnisse

CMC Technical Documentation

Process Validation

Injectable Formulations

Managing External Manufacturing Partners

Regulatory Compliance

Ausbildung

University degree in a life-science related subject

Jobbeschreibung

What you will enjoy:

• A challenging position – ideal if you are passionate about new scientific challenges: You will take on an exciting cross-functional role at the interface between the laboratory, manufacturing, and CDMOs. A key part of your responsibilities will be the active authorship and development of CMC documentation (Modules 2.3 and 3), laying the foundation for efficient and scalable manufacturing and tech transfer processes.

• Through your work, you will help bring innovative injectable products to market and make a difference for oncology patients worldwide – in fact, the products have already been used at the Memorial Sloan Kettering Cancer Center (USA) and ETH Zurich (Switzerland).

• Work-Life Balance is perfectly given, as the role is 95% remote

What You Will Do:

• Independently author and manage CMC documentation (Modules 2.3 and 3)
• Lead process development and validationmanufacturing workflows and reagent kits.
• Ensure manufacturing processes are robust, scalable, and regulatory-compliant for clinical supply and beyond
• Collaborate closely with R&D, Quality, and Product Development teams to troubleshoot and optimize analytical and manufacturing processes.
• Manage technology transfer activities with CMOs and ensure all deliverables meet GMP and ICH standards.

What You Bring

This role requires solid scientific foundation and hands-on executional skills. You must be able to independently own and drive CMC development across early- to late-stage injectable programs.

Mandatory Requirements:

• University degree in a life-science related subject
• Hands-on experience with writing themodules 2.3 and 3 (CMC Technical Documentation)
• Proven expertise in CMC development, process validation, and technology transfer.
• Practical experience in injectable formulations.
• Strong background in managing external manufacturing partners (CDMOs/CMOs).