Proclinical is advertising an exciting opportunity for a position as Senior Manager/Associate Director with an innovative biotechnology company that specialises in in gene-based research. This company, which has three programs in late-stage clinical development and multiple programs in early-stage clinical development, is seeking for a Senior Manager/Associate Director to come on board their team based in Frankfurt.
The Senior Manager/Associate Director will be responsible for technical on-site activities with the manufacture of oligonucleotide drug substances as the company's manufacturing partner. They will provide support for on the floor manufacturing activities, validation readiness activities, deviation, change control, and CAPA championing, as well as regulatory submissions. They will provide strong scientific leadership and hand-on support for all aspects of technology transfer, process scale-up, process monitoring, and process troubleshooting of drug substance manufacturing activities. The Senior Manager/Associate Director will collaborate with the local company Quality Assurance partner to ensure the successful development of all products. Finally, the Senior Manager will foster effective cross-functional working relationships with internal and external groups, leading interacting with Process Sciences, Quality Assurance, Supply Chain, and Analytical Development for the technology transfer of new products and providing supporting for Regulatory submissions related to products manufactured on the site.
Job Responsibilities:
- Serving as lead for all technical activities associated with the manufacture of oligonucleotide dug substances as the company's manufacturing partner.
- Partnering with CMO to ensure successful manufacture of drug substance required for clinical supply, process validation, and commercial supply.
- Providing guidance to process validation activities at the contract manufacturing facility.
- Providing technical input to Process Sciences for defining the critical process parameters of new processes.
- Collaborating with local Quality partner and US team to develop processes and systems that enable compliant, successful technology transfers, operation, and lifecycle management of cGMP clinical and commercial manufacturing processes, ensuring all product delivery schedules are met.
- Providing significant technical depth to support troubleshooting efforts and leading high-level deviation investigations at internal and external manufacturing facilities.
- Managing technical relationships with drug substance contract manufacturer, including, but not limited to, providing person in plan support, technology transfer and validation support, deviation, change control, and CAPA management.
- Driving timely decisions and facilitating active communication and information flow between contract manufacturer and company team members.
- Authoring IND, NDA, and other technical documents for regulatory agency submission in support of manufacturing processes and serving as process subject matter expert in health authority interactions.
- Identifying and driving process optimisation initiatives and addressing opportunities for efficiency and capacity improvements in all areas of internal and external third-party manufacturing.
- Providing input on suitability of technologies, scalability, and manufacturability to Process Sciences during process development activities.
Skills and Requirements:
- A Bachelors' in an Engineering/Science field.
- At least 15 years of experience in a pharmaceutical manufacturing organisation, with expertise in multiple process areas (synthesis, chromatography, buffer preparation, and lyophilisation).
- A thorough understanding of cGMP requirements for clinical and commercial pharmaceutical manufacturing.
- Demonstrable experience supporting technology transfers and cGMP manufacturing operations at third party manufacturers required.
- Demonstrable experience supporting international Contract Manufacturing Organisations is highly desirable.
- A proven ability to make decisions based on GMP compliant requirement.
- Proven problem-solving skills.
- Proficiency in Microsoft Office, along with general computer skills.
- Proven organisational skills.
- An ability to work with limited supervision, to set priorities to meet timelines, and to motivate, persuade, and influence others.
- Excellent communication and English skills, in both oral and written capacities.
To Apply:
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 call Josh Godden on +442038540101 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.
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