Associate Scientist / Scientist I/II, Downstream
IGM Biosciences (Nasdaq: IGMS) is a clinical stage biotechnology company focused on creating and developing engineered IgM antibodies. IgM antibodies have inherent properties that we believe may enable them to improve upon the efficacy and safety of IgG antibodies in multiple therapeutic applications.
We have created a proprietary IgM antibody technology platform that we believe is particularly well suited for developing T cell engagers, receptor cross-linking agonists and targeted cytokines. Our lead product candidate, IGM-2323, is a bispecific T cell engaging IgM antibody targeting CD20 and CD3, for the treatment of relapsed/refractory B cell Non-Hodgkin’s lymphoma (NHL) patients. Our second product candidate, IGM-8444, is an IgM antibody targeting Death Receptor 5 (DR5). We have initiated Phase 1 clinical trials for both molecules.
We are seeking an Associate Scientist / Scientist I/II with experience in process development to join our rapidly growing Process Development and Manufacturing team. You should have a solid background in protein purification, the principles for process design and the bioanalytical techniques used to characterize biologics. In this role you’ll support or lead development programs that define, scale-up and transfer purification processes to GMP manufacturing, to advance our expanding pipeline of novel cancer therapies into human clinical studies. You will have the opportunity to collaborate across departments to advance multiple fast moving drug development projects.
- Lead the design and development of scalable purification processes to support the production and manufacturing of IgM/IgA molecules.
- Design and execute studies for key unit operations in the purification process using Design of Experiments (DOE) principles and high throughput formats, to meet the project timelines.
- Collaborate with Protein Sciences, Cell Culture Development, Analytical, and Manufacturing to design robust processes that balance the requirements of product quality, yield and manufacturability.
- Contribute to the tech transfer of purification processes (non-GMP and GMP) to internal Manufacturing and external (CDMO / CMO) organizations.
- Research literature to identify novel methodologies and solve scientific problems and apply to the overall program.
- Provide technical support, e.g. product impact assessments, process improvements, for ongoing clinical phase GMP manufacturing.
- Generate data for and author technical development reports, process validation protocols and reports and relevant sections in regulatory filings.
- Publish research in peer-reviewed journals and present work at scientific conferences when possible.
- Keep accurate and current records of research and/or project related activities and share data with management and team members.
- Ph.D. degree in chemical /biochemical engineering, biochemistry or related field with 2 + years of experience or Bachelor/Master’s with more than 6 years of post-degree experience in the biopharma industry.
- Expert in core purification unit operations including chromatography, viral filtration and tangential flow filtration, with hands-on experience using and maintaining AKTA (AVANT, Pure, Ready) systems with Unicorn software.
- Demonstrated capability for applying DOE and high throughput methodologies for process development and optimization (Tecan platform).
- Prior experience with tech transfer of manufacturing processes (internal /external) and interacting with CMO /CDMOs.
- Experience authoring development and validation reports, and translating content to CMC sections for IND submissions.
- Demonstrated capability with analytical characterization of biomolecules (HPLC, ELISA based methods, SDS-PAGE, Western Blot).
- Self-starter with ability to work independently or with limited direct supervision and effectively function in team environment.
- Excellent organization, interpersonal, and communication skills (both written and verbal). Able to clearly and effectively present data at group and company meetings.
- Creative, innovative, problem solver who thrives in a fast-paced, start-up environment.
- Must be able to commute to Mountain View.
We offer a fast-paced, collaborative, team-based and family-like work environment. It is one of our biggest goals to maintain our company culture.
One of our top priorities is to maintain the health and wellbeing of our employees and their families. To achieve this goal, we are offering robust and comprehensive benefits with a variety of options:
- Medical, dental and vision insurance. The full premium amount for our employees and their dependents is covered by IGM
- STD, LTD, Basic Life and AD&D Insurance, Supplemental Life and AD&D Insurance
- 401(k) Plan
- 120 hours of Paid Time Off, 5 sick days per year, 10 holidays
- Cell phone & internet subsidy
- Employee Referral Bonus Program
- Annual training budget for professional development
- Commuter Benefit
- Annual bonus program
- New hire stock options
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.