Senior CMC Analytical Lifecycle Manager

We are in search for a Senior CMC Analytical Lifecycle Manager to supply Analytical strategic and scientific expertise to CMC Development Teams in support of submissions to Regulatory authorities. This role is based in Switzerland is a fantastic opportunity to join a large biotech.

Job Responsibilities

• Provide analytical expertise and know how in the field of mAbs/protein analytics to deliver industry leading analytical packages in support of Product development of the required standard for adherence to Global Health Authorities
• 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
• Represent physchem analytics at Life Cycle Activities CommitteeManage direct/in
• 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 the company 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

Skills and Requirements

• 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 7years experience in R&D in biopharma/biotech industry specialising 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
• Excellent analytical and organizational skills
• Self-directed and motivated individual who can work effectively with limited direction in a complex, fast-paced environment with challenging timelines

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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