Associate Director, Downstream Process Development
Responsibilities of the Associate Director, Downstream Process Development:
- This position will be responsible for providing technical oversight for downstream operations during GMP manufacturing runs.
- The successful candidate will oversee process characterization for downstream activities.
- Utilization of multi- and single bioreactor systems for initial screening, process development, initial tox material generation.
- Application of DoE for process development/optimization to achieve higher productivity or improve product quality profile.
- Authoring and review of high-quality documents, including reports, SOPs, process characterization documentation, experimental protocols/reports;
- Leading the team of 5-10 people via providing expertise, scientific support in the following key activities of the department;
- Represent manufacturing during batch record review with Quality Assurance.
- Assist with the resolution of any deviations and facilitate the batch disposition process with Quality Assurance for downstream operations
Requirements of the Associate Director, Downstream Process Development:
- Masters or Ph.D. in engineering, chemistry, biology or other related scientific discipline.
- A minimum of 5 years experience in process development, process engineering and manufacturing.
- Experience with downstream processing and purification processes including chromatography, filtration, viral inactivation and buffer exchange.
- Prior experience with Process Characterization, Process performance qualification and Commercial Manufacturing is strongly preferred.
- Demonstrated track record of success in a leadership role delivering manufacturing or operations results in a biopharma or pharmaceuticals environment.
Commonwealth Sciences is a professional recruiting firm specializing in Life Science, Medical Device, and Engineering Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.