Analytical Scientist, Process Sciences
IGM Biosciences is a privately held, biotechnology company focused on the discovery and development of innovative therapeutic antibodies for the treatment of cancer, autoimmune disorders and infectious diseases. Since 2011, we have pioneered a new field of antibody development by creating novel IgM and IgA antibodies. Our proprietary platform of high avidity, natural and engineered human antibodies utilizes novel mechanisms of action that specifically target cell types involved in disease pathways. We are building a strong pipeline of biologics for oncology, infectious disease and immunology disease drug candidates.
We are seeking a collaborative and driven Analytical Scientist to work alongside our Process Sciences Group. This position will report to the VP, Manufacturing and Process Sciences. The position is responsible for analytical method development activities associated with the development of manufacturing processes for sterile injectable drug products including monitoring of upstream and downstream process steps, testing and characterization of drug substance and drug product. The position also participates in formulation development and supports research and development in clinical candidate selection.
Essential Duties and Responsibilities:
- Responsible for analytical test methods development to support in-process, drug substance and drug product testing
- Provides analytical characterization for research and development for selection of new pre-clinical candidates
- Performs development stability studies and studies in response to FDA information requests
- Correctly executes development activities as defined by senior scientific staff or management. Initiates and designs studies, as appropriate
- Applies basic scientific principles, technology and regulatory knowledge with minimal guidance
- Demonstrates the ability to interpret outcome of experiments and to propose appropriate follow-up experiments
- Trains personnel on analytical methods to enable them to perform independently
- Communicates own work effectively orally and in writing
- Contributes and/or prepares protocols, testing procedures, and technical reports.
- Performs literature searches and extracts relevant information from published information
- Reports and treats data with a high level of integrity and ethics
- Thoroughly and accurately documents experimental activities in laboratory notebooks.
Desired Education, Skills and Experience:
- PhD in a scientific discipline
- 3-10 years of relevant experience
- Experience in hands on analytical methods development in a pharmaceutical environment working on protein therapeutics preferably monoclonal antibodies
- Able to demonstrate proficiency in HPLC and Electrophoresis instrumentation and software is required
- Experience working with samples from recombinant manufacturing processes preferred
- Knowledge of basic computer programs routinely used in a lab such as MS Word, Powerpoint, Excel, GraphPad, etc.
- Ability to quickly learn and master new instrument software and programs.
- Excellent organization, interpersonal, and communication skills.
- Being a team player and respectful of others is a must.
- Experience in maintaining thorough lab records, and adhering to health and safety regulations
- Ability to thrive in a fast-paced, small start-up environment
Special Working Conditions:
- Travel approximately 10% of the time
The job description outlined above reflects general details as necessary to describe the primary functions of this job, the level of knowledge and skill typically required, but should not be construed as an all-inclusive listing of work requirements. Individuals may be asked to perform duties other than those mentioned above in order to cover absences or relief in the appropriate department to equalize peak work periods or otherwise balance the workload.
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.