Senior CMC Manager (Analytical Development) - Biotech

Proclinical is seeking a Senior CMC Manager woth a focus on Analytical Development and Biotech who can provide strategic and scientific expertise in support of submissions to Regulatory authorities. The successful candidate will be responsible for overseeing and responding to questions from regulatory authorities related to method performance, validation and transfer, stability, release specifications and interpretation of comparability and similarity data. This role involves interfacing with CROs and CMOs to ensure analytical life cycle maintenance and security of licensed product supply to the approved quality standard. This role is based in Switzerland.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities

• Provide analytical expertise in the field of mAbs/protein analytics.
• Collaborate with CMC Development teams, Regulatory Affairs and Quality functions to deliver analytical packages against project objectives.
• Write and review analytical relevant sections of Health Authority submissions including BLA and MAA and post-approval variations.
• Liaise with functional heads and Regulatory CMC to develop a portfolio of topic-specific templates.
• Represent physchem analytics at Life Cycle Activities Committee.
• Manage interaction with Fresenius-Kabi Analytical Teams in support of Phase III development, Biosimilar license application and post-marketing support.
• 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.
• Represent the company at regulatory authority meetings and at internal review committees.

Key Skills and Requirements

• Advanced scientific degree in biochemistry, bioanalytics or related fields. Further qualification such as MSc, PhD or specific vocational training would be an advantage.
• Fluency in English, 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.
• Sound knowledge in GLP/GMP, ability to interpret guidelines and to implement compliant analytical packages in highly regulated markets.
• Proven experience representing analytical development in regulatory consultations for biosimilar products and/or New Biological Entities in the EU/US.
• Excellent analytical and organizational skills.
• Leadership competencies, proactive problem solving, influencing and decision making.
• Excellent communication skills, both oral and written.
• Strong interpersonal, networking and relationship skills.

If you are having difficulty in applying or if you have any questions, please contact Dom Williams on d.williams@proclinical.com

Apply Now

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.