Principal Scientist / Sr. Scientist, Analytical Development

IGM Biosciences (Nasdaq: IGMS) is a clinical-stage biotechnology company pioneering the development of engineered IgM antibodies for the treatment of cancer, infectious diseases, and autoimmune and inflammatory diseases. IgM antibodies have inherent properties that we believe may enable them to bind more strongly to targets on the surface of cells than comparable IgG antibodies. We believe our proprietary IgM antibody technology platform is particularly well suited for developing T cell engagers, receptor cross-linking agonists, targeted cytokines, and target neutralizers.

Our lead product candidate, Imvotamab, is a bispecific T cell engaging IgM antibody targeting CD20 and CD3 proteins, and it is currently in two Phase 2 clinical trials for the treatment of relapsed and/or refractory diffuse large B cell lymphoma and follicular lymphoma. Our second product candidate is IGM-8444, an IgM antibody targeting Death Receptor 5 (DR5) for the treatment of patients with relapsed and/or refractory solid and hematologic malignancies, and it is currently in a Phase 1 clinical trial. Also in our product pipeline is IGM-7354 and IGM-2644. IGM-7354 is an anti-PD-L1 IgM antibody that targets the delivery of interleukin-15 (IL-15) cytokines to the area of PD-L1 expressing cells for the treatment of patients with solid and hematologic malignancies. IGM-2644 is a bispecific T cell engaging IgM antibody targeting CD38 and CD3 proteins for the treatment of patients with multiple myeloma.

Position Summary

Our Analytical Development group is seeking a Principal Scientist / Senior Scientist to assume a leadership role in establishing the analytical methodologies to characterize IgM based therapeutics. In this critical role, you will provide technical mentorship and guidance to a team of scientists / research associates responsible for developing the optimal analytical approaches for understanding IgM molecules, and the delivery of analytical methods for drug substance and drug product release and characterization to support IND / BLA enabling activities.

Responsibilities:

* Guide team on method development with assay qualification/validation in mind, for an array of analytical methods needed for product release
* Expertise in UV-VIS, SDS-PAGE, SEC-HPLC, RP-HPLC, LC-MS, CE-SDS and cIEF/IEX
* Familiarity with cell-based potency assays (TCA, CDC) and impurity assays including HCP-ELISA and residual CHO DNA
* Enthusiastic to apply DOE methodology and QbD principles for assay and formulation development
* Capability to design and guide execution of formulation development studies and corresponding analytics including osmolality, UV-VIS, pH, DLS, SEC-HPLC, particle size analysis (e.g. FlowCam), etc.
* Author and Review SOPs, protocols, technical documents and Regulatory filing content
* Analyze scientific/technical data and present data in department and CMC team meetings.
* Maintain an organized analytical lab environment and comply with Federal and California safety regulations
* Champion the evaluation and implementation of new analytical technologies
* Other duties may be assigned

Qualifications:

* Level commensurate with experience.
* Ph.D. in Analytical Chemistry, Biochemistry, Molecular Biology, or related scientific discipline
* Principal: PhD with 12+ years, MS with 17+ years, or BS with 20+ years of experience in the biotech/biopharmaceutical setting
* Senior Scientist: PhD with 8+ years, MS with 15+ years, or BS with 17+ years of experience in the biotech/biopharmaceutical setting
* 3+ years of management and leadership experience in Analytical Development with a commitment to mentorship and development of personnel
* Ability to contribute independently and direct a team of scientists/ research associates supporting a portfolio of projects at different stages
* Lead assay development activities, including method qualifications and transfers, required for clinical and late-stage molecules
* Preparation of CMC documentation for regulatory submissions (IND / BLA)
* Actively participate in the design of specifications in alignment with control for drug substance and drug product
* Internal and external communication with colleagues and third-party vendors to ensure optimal execution and record of analytical activities
* Support troubleshooting issues that occur during development, scale-up, and in GMP manufacturing
* Demonstrated ability to work independently across functional areas to design assays that can be implemented in a Quality control lab
* Strong interpersonal and excellent communication skills are a must
* Extremely well organized with great attention to detail
* Flexibility to work on multiple projects in a fast-paced environment is essential
* "Roll up the sleeves" mentality
* Must be able to commute to Mountain View

We offer a fast-paced, collaborative, team-based, and family-like work environment.

One of our top priorities is to maintain the health and wellbeing of our employees and their families. To achieve this goal, we offer 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
* FSA (Flexible Spending Account)
* 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, 11 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.