ProClinical is seeking an Associate Director, Manufacturing for a fast growing globally represented Biotech which is currently establishing its European production in Germany. The successful candidate will be responsible for all technical activities associated with the manufacture of our Clients products at the manufacturing partners (CMOs). The candidate will provide support for on the floor manufacturing activities, validation readiness, deviations, change control and CAPAs. The candidate needs to provide also hands-on support for all aspects of technology transfer, process scale-up, process monitoring, and process troubleshooting. This is a contract role based in Frankfurt, Germany.
- Serve as lead for all technical activities associated with the manufacture of drug substance at our Clients contract manufacturing partners in Frankfurt, Germany
- Partner with CMO to ensure successfully manufacture of drug substance required for clinical supply, process validation and commercial supply.
- Provide guidance to process validation activities at the contract manufacturing facility. Provide technical input to Process Sciences for defining the critical process parameters of new processes.
- Collaborate with local Quality partner and US teams 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.
- Provide significant technical depth to support troubleshooting efforts and lead high-level deviation investigations at internal and external manufacturing facilities.
- Manage technical relationships with drug substance contract manufacturer including, but not limited to providing person in plant support, technology transfer and validation support, deviation, change control and CAPA management. Drive timely decisions, and facilitate active communication and information flow between contract manufacturer and our Clients team members.
- Author IND, NDA and other technical documents for regulatory agency submission in support of manufacturing processes and serve as process subject matter expert in health authority interactions.
- Identify and drive process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of internal and external third-party manufacturing.
- Provide input on suitability of technologies, scalability and manufacturability to Process Sciences during process development activities.
Skills and Requirements:
- Degree (graduate degree preferred) in science or engineering
- Minimum of 6-year experience in a pharmaceutical manufacturing organization, with expertise in multiple process areas (synthesis, chromatography, ultrafiltration and lyophilization)
- Comprehensive understanding of cGMP requirements for clinical and commercial pharmaceutical manufacturing
- Demonstrated experience supporting technology transfers and cGMP manufacturing operations at third party manufacturers required.
- Experience supporting international Contract Manufacturing Organizations highly desirable
- German and English fluent in Word and Speech
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 Nick Dietz on +44 203 3193 033 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.