QC Analyst / Sr. QC Analyst
IGM Biosciences, Inc. (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, that is currently in a Phase 1 clinical trial for the treatment of relapsed/refractory B cell Non-Hodgkin’s lymphoma (NHL). Our second product candidate is IGM-8444, an IgM antibody targeting Death Receptor 5 (DR5) for the treatment of patients with solid and hematologic malignancies. Also in our product pipeline is IGM-7354, a bispecific IgM antibody delivering interleukin-15 (IL-15) cytokines to PD-L1 expressing cells for the treatment of patients with solid and hematologic malignancies.
In this new role at IGM, you will conduct the quality control (analytical) testing of clinical and commercial supplies for on-site manufacturing. In addition, you will qualify/validate testing methods. The Quality Control Analyst will report to the Manager of Quality.
- Conduct routine and non-routine analytical, biochemical, and/or biological analysis such as in-process materials, raw materials, finished goods, or stability samples.
- Perform timely and accurate peer review of analytical test results report/notebooks.
- Prepare Certificate of Analyses for testing performed.
- Identify discrepancies, initiate and investigate OOS/OOT results for phase 1 and phase 2. Write OOS/OOT report.
- Initiate and investigate deviations related to quality control.
- Compile and review data to ensure accuracy and regulatory compliance.
- Support development for specifications and justification of specifications.
- Participate in validation and technical transfer of analytical methods commensurate with experience.
- Write and revise testing methods.
- Maintain required training and training records and provide training to qualify other Associates.
- Participate in internal assessments and audits as required.
- Support Equipment validation, calibration, maintenance, and troubleshooting.
- Write method validation protocols/reports and other documentation such as test reports.
- Write stability protocols and stability reports.
- Write and revise standard quality control operations procedures.
- Supply quality control data necessary for regulatory submissions.
- Support quality systems such as change control, deviations, CAPA, audits, quality metrics, annual product review, and person in plant.
- BA or BS degree in a scientific discipline preferred, or comparable experience.
- Experience with protein/large molecule assays such as HPLC, gel electrophoresis, ELISA, or cell-based assays.
- 2 years of experience in cGMP or cGXP at an operational level supporting manufacturing in a pharmaceutical or biotech environment, is preferred.
- Experience with Phase 1, 2, or 3 and / or commercial drug substance/drug product manufacturing is preferred.
- Prior experience related to method development/validation is preferred.
- Prior experience with HPLC, GC, and/or biological assays.
- Knowledge of pharmaceutical cGMPs (US and EU) is preferred.
- Must have excellent verbal, written, interpersonal, and organizational, and communication skills.
- Must be able to commute to Mountain View.
- 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.