Senior CMC Project Lead
A truly global player in the discovery of new molecules are looking to expand their team by recruiting a Senior CMC Project Lead. The company prides itself on its significant presence in the branded generics market across emerging economics, including parts of Asia. This role will be based at their site in Switzerland, offering an exciting opportunity to work with an international team of over 9,000 employees based in over 80 countries.
- Lead late stage CMC Development of NBEs as well as supporting potential new indications.
- Project Manage and Lead the CMC core team, including tech transfers and up scaling activities as well as Process Characterization activities.
- Ensure alignment and follow-up with the functional leads/line managers (PS, MSAT, QC, QA, RA, and Clinical Operations) and external consultants for timely execution of deliverables.
- Serve as a point of contact for CMOs and CROs related to DS and DP manufacturing.
- Present project status/risks/mitigations etc. on a regular basis to senior CMC management team and relevant Global Stakeholders to secure alignment and structured decision making.
- Author or review critical CMC documentation - CMC development plans, regulatory submissions, minutes of internal and external meetings, QTPP, risk assessments etc.
- Prepare, follow, and adjust the CMC project budget and resource forecasting.
- Manage CTM supply according to the Clinical Development Plans as well as product disposition and inventory.
- Serve as CMC representative in the Global Compound Development Team ensuring alignment between the CMC activities and the Program strategy and requirements and providing updates and proposed CMC strategy to the Program Team.
Skills and Requirements:
- MSc/PhD or equivalent in biochemical engineering, biochemistry, biology, pharmacy or related discipline.
- 10 years or more of relevant biologics CMC (including project management) experience in an industrial setting.
- In-depth knowledge of current GMP guidelines, familiarity with regulatory authority submissions (IMPD/IND/BLA), quality, and technical agreement drafting (CMO).
- Experience (hands-on or theoretical) in process/analytical technology transfer and process scale up/validation.
- Experience with drug development of Antibodies.
- Experience with late stage development (Process Characterization and PPQ).
- Experience with PFS - preferred.
- Proficiency in state-of-the-art project management tools.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Chidozie Orji at +44 207 440 0671 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
€70.00 - €80 per hour
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