Director of Downstream Process Development
Proclinical is currently recruiting for a Director of Downstream Process Development with a with a leading biopharmaceutical company located in Gaithersburg, MD. As the Director of Downstream Process Development, you will play a key role in creating the overall strategy for downstream development processes across the company's product pipeline.
- Lead a function responsible for the development of purification processes.
- Identify and develop new technologies to improve purification capabilities.
- Design effective experiments using a Design of Experiments approach, incorporating Quality by Design into the process characterization
- Contribute towards scale up, characterization, and optimization of all programs.
- Leading process validation activities and strategies including the evaluation of downstream process characterization plans
- Participate in tech transfer to cross-functional groups and external partners
- Manage direct reports including Scientists and Engineers.
- Prepare and review process development reports, protocols and reports, CMC regulatory filings.
Skills and Requirements:
- PhD or MS with experience in pharmaceutical, biologics, or vaccine product development
- Strong expertise in process design and development of purification operations.
- Strong understanding of FDA regulatory requirements
- Knowledge and expertise in GMPs principle
- Experienced in tech transfers
- Ability to manage and develop a team
If you are having difficulty in applying or if you have any questions, please contact Alec Tooulas at (+1) 917-284-9670 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.