Experienced Director if a Biotechnology Environment? Take a closer look!
This Jobot Job is hosted by: Jenner Wiggins
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Salary: $200,000 – $250,000 per year
A bit about us:
We are a Privately owned immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious diseases. .
Why join us?
- Competitive Base Salary!
- Extremely Competitive Equity Package!
- Flexible Work Schedules!
- Accelerated Career Growth!
- Company Matched 401(k)!
Job Details
SUMMARY:
As the Senior Director, Process Technical Services you will provide technical and organizational leadership to develop solutions in support of clinical and commercial manufacturing for internal manufacturing operations of our cell therapy and protein therapy programs. The primary responsibility is to provide technical and scientific support to GMP manufacturing processes.
MUST HAVES:
- Upstream Cell Culture
- People Management
- Tech Transfer & Scale Up
- Bioprocess Experience
DUTIES & RESPONSIBILITIES:
- Provide ongoing technical support for manufacturing processes that are currently being manufactured internally. Includes support of discrepancies, investigations, and change control; process data review; implementation of process improvements
- Direct the Manufacturing Process Scale-Up, discrepancy and investigation evaluations, change control, and regulatory submissions. Support process validation activities. Lab work may be required in order to resolve investigations and/or demonstrate proof-of-concept for proposed process changes.
- Provide Subject Matter Process Expertise to support technology transfers to and from external manufacturing organizations, as well as between IB Drug Substance manufacturing sites and from Process Development.
- Responsible for authoring technical reports, manufacturing instructions, process validation documents, and portions of regulatory submissions to support licensing processes at new manufacturing sites, for new pipeline products or process changes.
- Work collaboratively across the Manufacturing network to identify and communicate standards and best practices for manufacturing to ensure consistency across the biologics cell culture manufacturing facilities.
- Own the Process Life-Cycle and yield improvement plans for cell therapy and protein therapy Manufacturing products
EDUCATION & EXPERINECE:
- Masters in Biochemical Engineering
- 10+ years of cell culture and/or E. coli bioprocess development or in supporting manufacturing operations
- Proven track record in cGMP at scale manufacturing operations support, including problem solving and successful delivery of cross-functional technical projects.
- Experience in either design, qualification, start-up or initial licensure of Biologics Mfg. facilities preferred
Interested in hearing more? Easy Apply now by clicking the “Apply Now” button.