(Senior) Manager CMC Analytical Life Cycle (m/f/d)

Focus of the role:

Supply Analytical strategic and scientific expertise to CMC Development Teams in support of submissions to Regulatory authorities for all aspects of CMC analytical packages.

Oversee and be responsible for responding to questions from regulatory authorities related to method performance, validation and transfer, stability, release specifications and interpretation of comparability and similarity data in co-ordination with the appropriate experts.

Author, review and validate analytical CMC sections of dossiers delivered to regulatory agencies from analytical data/source documents, ensuring cGMP compliance and data integrity in line with Fresenius Kabi's corporate quality standards.

Interface with CROs and CMOs to ensure analytical life cycle maintenance and security of licensed product supply to the approved quality standard.

• Provide analytical expertise and know how in the field of mAbs/protein analytics to deliver industry leading analytical packages in support of Fresenius Kabi Biosimilar Product development of the required standard for adherence to Global Health Authorities (in particular US and EU) requirements
• Collaborate with CMC Development teams, Regulatory Affairs and Quality functions to co-ordinate and deliver analytical packages against the project objectives
• Work with subject matter experts to write and review analytical relevant sections of Health Authority submissions including BLA and MAA and post-approval variations
• Drive best practice to ensure efficient and timely response to regulatory questions from within Analytical Development
• Liaise with functional heads and Regulatory CMC to develop a portfolio of topic specific templates based on HA guidance documents and / or standard HA information request answers
• Manage direct/indirect interaction with Fresenius-Kabi Analytical Teams in support of Phase III development, Biosimilar licence application and post-marketing support ensuring scientific rigor and data integrity
• Development of long-term plans for analytical support of licensed Biosimilar products
• Develop risk management strategies for product lifecycle maintenance
• Interface with external CROs, CMOs and licensing partners to set expectations, define work packages, measure progress and delivery including continuous method performance monitoring
• Represent Fresenius-Kabi SwissBioSim at regulatory authority meetings and at internal review committees
• Ensure rigorous and timely decision making that maintains rapid project progression while continuously weighing the many variables and uncertainties associated with the biosimilar business

• Advanced scientific degree: Degree in biochemistry, bioanalytics and post grad training in respective fields. Further qualification such as MSc, PhD or specific vocational training would be an advantage
• Fluency in English essential, both oral and written; additional languages (German or French) are an asset
• Minimum 7 years experience in R&D in biopharma/biotech industry specializing in mAbs/protein analytics
• Proven ability to rapidly understand experimental procedures, data, and concepts related to analytical development of biotherapeutics
• Sound knowledge in GLP/GMP, ability to interpret guidelines and to implement compliant analytical packages in highly regulated markets, Familiarity with BLA/MAA filing and ICH guidelines required
• Proven experience representing analytical development in regulatory consultations for biosimilar products (preferably) and/or New Biological Entities in the EU/US
• Significant exposure to and related analytics from Phase III development to licensed Biopharmaceuticals including product life cycle management and product maintenance biotech manufacturing operations
• Leadership competencies (proactive problem solving, influencing and decision making)
• Ability to work accurately with attention to detail, managing complexity, motivated and focused on delivery to product objectives
• Excellent communication skills, both oral and written with demonstrated ability to summarize analytical studies from reports and presentations; in a clear and succinct style
• Strong interpersonal, networking and relationship skills required, including teamwork and listening skills