CMC Project Manager
CMC Project Manager
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Job Description
The Company
AAVantgarde is a clinicalstage international biotechnology company headquartered in Italy. We have developed two cuttingedge AAV vector platforms to overcome DNA cargo limitations targeting Usher syndrome type 1B and Stargardt disease. Founded by the renowned Professor Alberto Auricchio a pioneer in gene therapy our mission is to transform genetic medicine for patients with no current therapeutic options. Join us at AAVantgarde and be a part of our innovative journey to bring the next generation of genetic medicines to those in need.
The Role
We are seeking a highly skilled and proactive CMC Project Manager to oversee the CMC activities supporting our gene therapy programs. This pivotal role will involve coordinating crossfunctional teams to ensure the seamless of CMC strategies and delivery of highquality gene therapy products in compliance with regulatory standards. The successful candidate will play a critical role in managing timelines internal teams and external partnerships ensuring the alignment of CMC activities with company objectives. This role reports to the Director of External Manufacturing
Oversee the planning and timely delivery of all CMCrelated project activities at our CDMOs including process development analytical development technology transfer manufacturing and quality control.
Ensure the CMC plans are in alignment with the Program objectives
Facilitate crossfunctional team meetings providing updates on project progress challenges and solutions.
Foster effective communication and alignment between the technical teams Quality Assurance Regulatory Affairs and Supply Chain.
Develop and maintain detailed project timelines and weekly project dashboards.
Own the risk and issues register including mitigation plans across all stages of CMC development and manufacturing.
Oversee the projectrelated budget
Capture all key decisions and keep an action tracker that is proactively managed
Skills and Experience Required
The successful candidate will have a bachelors degree in science or an engineering discipline ideally with an accredited PM qualification (PRINCE2/AgilePM/PMP). You will have a minimum of 8 years experience 3 of which should be within the biotech or pharmaceutical industry preferably with a focus on cell and gene therapy. You will have demonstrated experience working for or with CDMOs. You will also be proficient in project management tools and software (e.g. MS Project Smartsheet etc).
Whats in it for You
At AAVantgarde we believe in creating an environment where our employees can thrive. Our flexible working environment allows you to balance work and life effectively. Our central London office just a stones throw from London Victoria train station offers a prime location with topnotch facilities including a gym coffee shop and a rooftop garden. As a rapidly growing biotech with recent funding there are ample opportunities for career advancement and as we grow so can you. We offer a generous salary bonus pension health insurance through Vitality and income protection ensuring you have the support and resources you need to succeed. Join us and be part of an exciting innovative journey in the world of biotechnology.
Equal Opportunities
At AAVantgarde we are committed to fostering a welcoming collaborative and inclusive environment. We believe in providing equal opportunities for all and do not discriminate on the basis of race colour religion sex sexual orientation gender identity national origin disability or any other legally protected characteristics. All applicants will receive equal consideration for employment.
Recruitment Policy
AAVantgardes HR team leads all recruitment activities for AAVantgarde globally. AAVantgarde will not recognise any notional ownership recruitment companies claim to hold over candidates they present directly to hiring managers without the AAVantgarde HR teams consent nor any fees the recruitment company may feel are due as a result of this. Unsolicited resumes sent to AAVantgarde from recruiters do not constitute any type of relationship between the recruiter and AAVantgarde and do not obligate AAVantgarde to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring managers or employees. If you are interested in becoming a recruitment partner please email the HR team at
Required Experience:
Manager
Employment Type
Full-Time
