We are hiring a Manager for the Upstream Manufacturing group to join our rapidly growing team. In this important position, you will build and manage a team to execute CHO based cell culture processes following GMP guidance, generating clarified Harvested Cell Culture Fluid (HCCF) to be used for further manufacturing by the Downstream manufacturing team. This role will also include a close working relationship with the Process Development team to perform technology transfer of multiple molecules to support GMP level manufacturing. These efforts are all focused to help advance novel cancer therapies into human clinical studies.
- Experience with operating benchtop bioreactors, pilot scale bioreactors and mini bioreactors such as AMBR250 preferred but not required.
- Scale up cell culture processes to a 1000 L disposable stirred tank bioreactor.
- Collaborate closely with Upstream and Downstream development, Downstream manufacturing and Quality groups to meet project timelines.
- Lead the technology transfer of cell culture processes from the development group into GMP manufacturing.
- Enhance cell culture process understanding and participate in platform optimization efforts.
- Expertise with media/feed optimization and perfusion cultures is a plus.
- Write clear and concise Standard Operating Procedures (SOP’s), Production Documents and forms/addenda to facilitate GMP manufacturing.
- Perform timely production reviews on operator completed GMP documentation and batch records.
- Contribute to GMP campaign summary reports, relevant CMC sections in regulatory filings and technical development reports.
- Hire train and develop an efficient well-developed upstream operations team.
- Manage and evaluate the team holding direct reports accountable for performance.
- Partner with Quality and Safety to ensure best efforts compliance.
- Drive process improvement and metric progress in key areas of responsibility: safety/culture, quality/delivery, cost-effectiveness, efficiency.
- Support the Request For Proposal (RFP) and diligence process for all external manufacturing contracts.
- B.S. degree in Engineering, Life Science or related field, and 5+ years in manufacturing biologics under GMP to support FDA/EMA approved clinical trials.
- Minimum of 2 years of management and leadership experience.
- Knowledge of GMP manufacturing requirements related to clinical production and commercial manufacturing of injectable products.
- Lean Manufacturing implementation experience preferred.
- Experience operating single use upstream manufacturing processes considered a plus.
- Strong leader and mentor.
- Excellent verbal and written communication.
- Proficiency using Microsoft Office, relational databases, cloud-based document control systems (i.e. TrackWise, Veeva, Master Control etc.) and graphing programs.
- Aseptic technique.
- Able to multitask.
- Extremely well organized with great attention to detail.
- Able to thrive in a fast-paced, start-up environment.
- “Roll up the sleeves” mentality.
- Must be able to commute to Mountain View, CA.
- This job involves working under BSL-1 conditions.
- Capable of lifting upwards of 50 pounds infrequently.
IGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. All qualified applicants will receive consideration for employment.