We are hiring a Manager for the Downstream Manufacturing group to join our rapidly growing team. In this important position, you will build and manage a team to execute monoclonal antibody based downstream processes following GMP guidance, generating bulk drug substance to be used for further manufacturing by contracted fill and finish organizations. 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 ÄKTA purification systems and UNICORN 7 (or equivalent) required.
- Expertise and understanding of large protein molecule/monoclonal antibody separation and impurity clearance from harvested cell culture fluid, based on size, physico-chemical properties and binding affinity.
- Experience with packing and unpacking multiple types of resins/media to perform capture, elution and polishing required.
- Experience with operating TFF/UFDF skids and viral inactivation and filtration required.
- Collaborate closely with Upstream and Downstream development, Upstream manufacturing and Quality groups to meet project timelines.
- Lead the technology transfer of purification processes from the development group into GMP manufacturing.
- Enhance antibody purification process understanding and participate in platform optimization efforts.
- 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 downstream 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 downstream 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.