To whom it may concern,
We have been informed that certain persons have been claiming to be representatives of Vivet Therapeutics and contacting candidates about job positions at Vivet, particularly through job search engines such as CareerBuilder. Please be aware that these actions are not authorized or undertaken by Vivet Therapeutics. Except for the one below, Vivet currently has no open job positions, and we have not mandated any person or company to contact candidates or organize job interviews on our behalf. If you are contacted about a job position at Vivet, we strongly advise that you reject such proposal and do not provide any personal information. We have informed uscareers website of such issue of this issue, and hope that it will be resolved shortly.
Vivet has currently 1 open job position - Vivet Headquarters (Paris - France)
Senior CMC Manager - Gene Therapy and Biologics
Company: Vivet Therapeutics is committed to developing an innovative liver-directed gene therapy platform for the treatment of rare and severe inherited metabolic disorders
Job title: Senior CMC Manager - Gene Therapy and Biologics
Classification: Full-time position, based at Vivet Therapeutics Headquarters, Paris, France
Reports to: Chief Development Officer (CDO)
No direct report
Summary of key job aspects:
The Senior CMC Manager is responsible for technical management of bioprocess and analytical development, and manufacturing activities for Vivet’s projects (AAV based gene therapy). The CMC Manager is responsible for leading and managing activities from early development process up to clinical manufacturing, including but not limited to the process scale-up, analytical development, validation, technical transfer, etc. All technical activities for assigned CMC programs should be managed considering all aspects for ensuring pre-clinical and clinical supplies on time and providing the documentations to support IND/IMPD submission.
The key functions of the Senior CMC Manager include:
• The operational management of CMC activities of assigned programs encompassing process and analytical development and validation, manufacturing and control of Vivet products under ICH/GLP/GMP requirements, and supply (nonclinical and clinical grade).
• The follow-up and monitoring of activities conducted by Contract Research Organizations (CROs)/Contract Development and Manufacturing Organizations (CDMOs) related to assigned CMC programs. This comprises the successful delivery of product batches from pilot through clinical scale.
• The active contribution to CMC regulatory writing of relevant sections under the guidance of the Regulatory department, for regulatory consultations, IND/IMPD filing and responses to health authorities.
• Define and manage CMC activities relating to assigned Vivet programs in collaboration with the CDO, comprising process development, GMP manufacturing, analytical development, validation, formulation, technology transfer, in close collaboration with QA.
• Contribute with the CDO and external experts when required, to build the technical strategy in accordance with regulatory, quality and clinical standards, and ensure its integration into the assigned CMC programs to meet timelines and budget.
• Identify and CROs and CMOs for subcontracted CMC activities, establish RFPs (requests for proposals), analyse proposals, present to management and make recommendation for selection.
• Directly manage CROs and CMOs in charge of the technical activities relating the assigned CMC programs, ensure that the deliverables are reached within the expected quality and timelines.
• Identify and anticipate potential issues (technical, quality, timelines) that could arise during product development programs assigned and that may affect the project outcomes. Raise problems and propose solutions to the management. Play an active role in reaching timely decisions that resolve the issues.
• Ensure delivery of preclinical and clinical materials to support toxicology and clinical studies.
• Ensure CMC readiness for filing and responses to health authorities. Contribute to the writing of CMC section of regulatory documents (consultations, INDs/IMPDs, Investigator Brochure, Pharmacy Manuals, etc.), and ensure timely availability of all necessary technical documents from CROs and CMOs.
• Work closely with Vivet CDO for scheduling CMC activities et establishing priorities.
• As the CMC functional team leader and representative for assigned Product, attend and present progress at PTMs (Project Team Meetings), and ensure clear and synthetic regular presentations of the status, results and issues of the assigned CMC programs to project leaders (PL) and top management.
• Ensure technological intelligence on emerging technologies (process & analytical) by discussing with potential new vendors to assess capabilities and establish good relationships,
• Develop and maintain network of external experts for both data review and strategic proposal for project decision.
• Establish and follow the CMC yearly and multi-yearly budgets for assigned programs.
• Master or Ph.D. in biotechnology field (molecular biology, virology, bioprocess).
• Minimal of 8 years of experience in bioprocess, manufacturing and analytical field with technical and management responsibilities.
• Very good knowledge in GMP, biomanufacturing sciences, QA/QC and regulations.
• Experience and good knowledge of gene therapy products is a real plus.
• Demonstrated ability to lead upstream and downstream activities conducted by CROs/CDMOs.
• Analytical thinker with problem-solving mindset.
• Good written and oral communication skills.
• Fluency in English as a business language.
• Excellent planning, organization and time management skills.
• Highly proactive, self-motivated, professional and dedicated.
• Autonomous, rigorous, and careful to details.
• Good communication skills within small biotech organisation.
If you are interested please apply to firstname.lastname@example.org