Senior CMC Analytical Lifecycle Manager

Highly Competitive
  1. Permanent
  2. Analytical Chemistry
  3. Switzerland
Nyon, Switzerland
Posting date: 21 Apr 2021

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

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