(Associate) Director PD-CMC
| Location: || Amsterdam (Netherlands)|| || |
| Job category: || PD - Early Dev't|| || |
uniQure is dedicated to bring innovative therapies or unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life by (i) living up to high quality standards and (ii) recognizing the sense of urgency in areas of high medical need.
Purpose of the role
The (Associate) director will hold a key role in inuQure’s early development programs. The focus is on product development with the aim of a technology transfer to late-stage PD at our manufacturing site.
Place in the Organization
The Process Development (PD) department at Amsterdam is a part of the global Research and Product development organization at uniQure. PD Amsterdam is responsible for innovation and development of production processes for pre-clinical and clinical manufacturing of AAV-based gene therapy products. Within the PD department, you will be leading the Process Development CMC (PD-CMC) team. This team is responsible for process development and for pre-clinical manufacturing of AAV-based gene therapy products. In addition, the department is responsible for transfer of the developed processed to the late stage PD department for scaling-up and supports process characterization, process validation, process improvement and troubleshooting.
Key result areas (major duties, accountabilities and responsibilities)
- Serve as an expert for early Process development and technology transfer
- Ensures operations for production for on early stage (research) programs by providing AAV batches suitable for research and development studies
- Ensures early stage (preclinical to clinical) process development and preclinical manufacturing as a part of (IND enabling) CMC programs.
- Ensures process transfer to the (late-)PD department in for GMP manufacturing.
- Develops Strategy and tactics to introduce new or improve technology of platform process and new process technology.
- Writes and contributes regulatory submission documents.
- Oversees internal and external plans, reports, and quality documentation.
- Maintains a robust communication with all relevant functions within uniQure, especially with Late-PD, MSAT and Manufacturing departments.
Qualifications & Skills
- Holds a PhD or equivalent in a relevant area (e.g Engineering, Bioprocessing, Life science). Masters education is considered based on the experience
- 6 (associate) of 10 (director) years experience in biopharmaceutical development, with at least 4 (associate) of 6 (director) years is an equivalent position.
- Strong knowledge in Process Development of complex biologics/ATMPs
- Basic knowledge (Associate) or Experience (Director) with regulatory filings (IND, IMPD, BLA, MAA).
- Excellent written and communication skills.
- Knowledge in Molecular biology, Virology or equivalent is an advantage
- Scientific excellence, the passion for state-of-the-art technologies
- Proactive attitude to look beyond the assigned tasks
- High level of ownership of the assigned programs
- Leader / team player with an attitude to mentor others
- Flexible to act in a highly dynamic and demanding environment