Senior Manager - CMC analytical Life Cycle
For our client based in Vaud canton, we're looking for a Senior Manager - CMC analytical Life Cycle
Key Responsibilities:
Provide strategic and scientific analytical expertise to CMC Development Teams in support of submissions to regulatory authorities, covering all aspects of CMC analytical packages.
Oversee and manage responses to inquiries from regulatory authorities related to method performance, validation and transfer, stability, release specifications, and interpretation of comparability and similarity data, in coordination with relevant experts.
Author, review, and validate the analytical CMC sections of regulatory submissions from source documents, ensuring cGMP compliance and data integrity in alignment with Fresenius Kabi's corporate quality standards.
Collaborate with CROs and CMOs to ensure the analytical life cycle management and secure supply of licensed products, meeting the approved quality standards.
Main Tasks:
- Provide expertise in mAbs/protein analytics to deliver high-quality analytical packages supporting Fresenius Kabi Biosimilar Product development that meet Global Health Authority requirements, particularly in the US and EU.
- Work closely with CMC Development Teams, Regulatory Affairs, and Quality functions to coordinate and deliver analytical packages aligned with project objectives.
- Collaborate with subject matter experts to write and review analytical sections of regulatory submissions, including BLA, MAA, and post-approval variations.
- Drive best practices to ensure efficient and timely responses to regulatory inquiries within Analytical Development.
- Develop topic-specific templates based on Health Authority guidance documents or standard regulatory information request responses, in collaboration with functional heads and Regulatory CMC.
- Represent physchem analytics in Life Cycle Activities Committees.
- Manage direct and indirect interactions with Fresenius-Kabi Analytical Teams to support Phase III development, biosimilar license applications, and post-marketing activities, ensuring scientific rigor and data integrity.
- Develop long-term plans for analytical support of licensed biosimilar products and implement risk management strategies for product lifecycle maintenance.
- Coordinate with external CROs, CMOs, and licensing partners to define work packages, monitor progress, and ensure continuous method performance.
- Represent Fresenius-Kabi SwissBioSim at regulatory authority meetings and internal review committees.
- Ensure timely decision-making that balances project progression with the complexities and uncertainties of the biosimilar business.
Qualification Profile:
Education & Languages:
- Advanced scientific degree (e.g., Biochemistry, Bioanalytics), with further qualifications such as MSc, PhD, or vocational training being an advantage.
- Fluency in English (oral and written) is essential; additional languages (German or French) are a plus.
Professional Skills & Experience:
- At least 7 years of experience in R&D within the biopharma/biotech industry, focusing on mAbs/protein analytics.
- Proven ability to quickly understand experimental procedures, data, and analytical development concepts related to biotherapeutics.
- Strong knowledge of GLP/GMP guidelines, with the ability to implement compliant analytical packages in highly regulated markets. Familiarity with BLA/MAA filing and ICH guidelines is required.
- Experience representing analytical development in regulatory consultations for biosimilars or New Biological Entities in the EU/US.
- Extensive experience in Phase III development, licensing of biopharmaceuticals, and managing product lifecycle and biotech manufacturing operations.
Personal Skills & Competencies:
- Excellent analytical, organizational, and leadership skills, with a proactive approach to problem-solving, influencing, and decision-making.
- Detail-oriented with the ability to manage complexity while staying focused on product objectives.
- Strong communication skills, both oral and written, with the ability to clearly summarize analytical studies in reports and presentations.
- Strong interpersonal and networking abilities, with a focus on teamwork and collaboration.
- +41 58 201 54 41
- Geneva Professionals Health Care & Life Sciences
