Proclinical Staffing

Senior CMC Analytical Lifecycle Manager

Aquitaine, France, Eysines
21 Apr 2021
05 May 2021
Chloe Yeung
Regulatory Affairs, CMC
Full Time
Contract Type
Experience Level
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 objectivesWork with subject matter experts to write and review analytical relevant sections of Health Authority submissions including BLA and MAA and post-approval variationsDrive best practice to ensure efficient and timely response to regulatory questions from within Analytical DevelopmentLiaise 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 answersRepresent physchem analytics at Life Cycle Activities CommitteeManage direct/inDevelopment of long-term plans for analytical support of licensed Biosimilar productsDevelop risk management strategies for product lifecycle maintenanceInterface with external CROs, CMOs and licensing partners to set expectations, define work packages, measure progress and delivery including continuous method performance monitoringRepresent the company at regulatory authority meetings and at internal review committeesEnsure 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 advantageFluency in English essential, both oral and written; additional languages (German or French) are an assetMinimum 7years experience in R&D in biopharma/biotech industry specialising in mAbs/protein analyticsProven ability to rapidly understand experimental procedures, data, and concepts related to analytical development of biotherapeuticsSound 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 requiredExcellent analytical and organizational skillsSelf-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.