Seeking a driven individual with biological downstream process development experience to be a valuable part of a growing oncology company. The candidate will join the Biological CMC Development and Manufacturing team as a Downstream Manager or Senior Manager.
The role is within a collaborative team environment. The candidate will aid in developing and applying operational plans to meet project timelines and the business objectives of the company.
The candidate will aid in managing external drug substance and drug product development and outsourced manufacturing sites. The candidate will collaborate with several internal and external functions including process development, analytical, regulatory, quality, and clinical.
Specific responsibilities include:
- Aid in the development of robust purification processes using multiple chromatography modes, filtration, and clarification technologies at CDMO site.
- In collaboration with CDMO design, characterize, and optimize downstream manufacturing
- Ensure well-organized, concise and complete documentation of all activities across all areas of responsibility process based on quality by design (QbD) principles.
- Aid in liquid drug product formulation development, technical transfer and fill at CDMO site.
- Aid with the technical transfer, scale-up and manufacturing of biological drug substance and drug product to support late-stage clinical studies.
- Interface with upstream, formulation, analytical, QA/QC, and regulatory groups to ensure alignment with overall program goals.
- Participate in designing phase appropriate viral clearance studies to enable regulatory submissions.
- Prepare supporting documents for CMC sections of regulatory submissions.
- Establish and maintain comprehension of current trends in purification technologies
- Set clearly defined objectives/goals with contract organizations to ensure delivery of high-quality results while maintaining budget and timeline.
Education / Experience / Skills:
- B.S. or M.S. in chemical engineering, biochemistry, or closely related field.
- 6 - 10 years of relevant experience within a process development and/or technical transfer environment.
- Must have practical experience with chromatography and membrane biological process development & scale up.
- Experience with outsourced contract partners is desired but not required.
- Must think creatively and critically and be able to work independently, determine appropriate resources for resolution of issues, and have strong organizational and planning skills.