Analytical Research Associate

We are seeking an experienced, hands-on team member to join IGM as an Analytical Research Associate.  In this important role, you will support IgM characterization and Process Development for the IND and clinical stage IGM biotherapeutics.

Responsibilities:

  • Following written SOPs for routine analysis of antibody products with UV-Vis, HPLC, SDS-PAGE, cIEF, DLS, qPCR, and ELISA.
  • Routinely determine endotoxin in antibody solutions.
  • Maintaining HPLC, UV-Vis, DLS, CE, and qPCR instruments.
  • Maintaining an organized analytical lab environment in compliance with safety regulations.
  • Practicing GLP for all lab related activities including but not limited to buffer preparation, sample handling, and analytical method execution.
  • Expected to provide analytical support for process development, analytical method development, and drug formulation development.
  • Expected to keep excellent documentation and to prepare SOPs, protocols, and technical documents.
  • Encouraged to explore and identify new analytical technologies.
  • Expected to analyze scientific/technical data and present data in project team meetings.

Qualifications:

  • BS in Analytical Chemistry or related fields with 5+ years of hands-on laboratory experience, preferably in the biotech/biopharmaceutical setting.
  • Experience with standard biological analytical methods SDS-PAGE, HPLC (SEC-, IEX-, RP-, EC-, HIC-), capillary electrophoresis (CE-SDS, cIEF), particle analysis by DLS, UV-Vis spectroscopy, and ELISA is required.
  • Experience with tissue culture technique and biologics sample handling.
  • Able to work independently on multiple projects simultaneously.
  • Strong interpersonal skills and excellent communication skills are a must.
  • Physical ability to lift up to 40lbs and work at the lab bench for extended periods of time.
  • Being a team player and respectful of others is a must.
  • Able to thrive in a fast-paced, start-up environment.
  • Able to commute to Mountain View.

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.

 

Director of Manufacturing

Our Manufacturing and Process Sciences group is seeking a Director of Manufacturing.   In this critical role, you will be responsible providing functional leadership for supply chain strategy, logistics, warehousing/distribution, manufacturing, site safety, quality, and employee engagement.

Requirements:

  • B.S. degree in Engineering, Science or related field, and 15+ years in manufacturing biologics.
  • Minimum of 5 years of management and leadership experience.
  • Knowledge of cGMP manufacturing requirements related to clinical production and commercial manufacturing of injectable products.
  • Lean Manufacturing implementation experience.
  • Strong leader and mentor.
  • Excellent verbal and written communication.
  • Extremely well organized with great attention to detail.
  • Able to work in a fast-paced, start-up environment.
  • “Roll up the sleeves” mentality.

Responsibilities:

  • Development of manufacturing plan and establishment of procedures to ensure high standards of quality, safety, efficiency and schedule compliance.
  • Oversee the internal construction of manufacturing capability, while managing ongoing external manufacturing to meet clinical requirements.
  • Hire, train, develop and evaluate team. Hold direct reports accountable for performance.
  • Partner with Quality and Safety to ensure compliance with quality and safety best practices.
  • Drive process improvement and metric progress in key areas of responsibility: safety/culture, quality/delivery, cost-effectiveness, efficiency.
  • Head the RFP and diligence process for all external manufacturing contracts.
  • Preparation of CMC documentation for regulatory submissions.

Must be able to travel ~10% of the time.

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.

 
 
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Scientist, Upstream Process Sciences

We are hiring a Scientist in our Upstream Process Sciences group to join our rapidly growing team. In this important position, you will support the development of novel antibody products by helping to create upstream processes producing these therapeutic antibodies. You will perform cell culture process development, scale-up, and technology transfer to help advance novel cancer therapies into human clinical studies.

Responsibilities:

  • Independently design, execute, and interpret cell culture experiments to answer specific scientific questions.
  • Experience with operating benchtop bioreactors, pilot scale bioreactors and mini bioreactors such as AMBR250.
  • Develop innovative technologies and enhance cell culture process understanding.
  • Scale up cell culture processes in a 200 L disposable bioreactor.
  • Collaborate closely with purification development group and other groups to meet project timelines.
  • Lead the tech transfer of cell culture processes for GMP manufacturing.
  • Participate in platform optimization efforts. Expertise with media/feed optimization and perfusion cultures is a plus.
  • Write technical development reports, GMP campaign summary reports and relevant sections in regulatory filings.
  • Publish or present scientific findings in peer-reviewed journals or conferences.

Qualifications:

  • Scientific degree in chemical engineering, bioengineering, or a related field, with at least 0 to 2 years of direct experience for PhD, or > 6 years for MS, or > 8 years for BS.
  • Proficiency using Microsoft Office.
  • Aseptic technique.
  • Able to multitask.
  • Able to thrive in a fast-paced, start-up environment.

This job involves working under BSL-2 conditions.

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.

 
 
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Senior Research Associate, Upstream Process Sciences

IGM Biosciences is hiring a Senior Research Associate in our Upstream Process Sciences group to join our rapidly growing team.  In this position you will support the development of novel antibody products by helping to create upstream processes producing these therapeutic antibodies. You will maintain and expand cells, support the upstream PD lab, and set up and execute antibody production runs at scale up to 25 liters, or larger if needed.

Responsibilities:

  • Maintain and passage CHO expression cell lines.
  • Transfect plasmids into expression cells for transient production.
  • Select and expand expression cell lines for both stable and transient production.
  • Maintain upstream development lab.
  • Determine expression titer by ELISA and other techniques.
  • Document results in laboratory notebooks.
  • Research literature to identify alternative methodologies and solve scientific problems, establish and qualify assays.
  • Prepare technical reports, summaries, and detailed protocols.
  • Share data with management and team members.

Qualifications:

  • BS/BA or higher degree in a biology-related discipline.
  • 3-5 years of experience working with mammalian cell culture and bioreactor/wave systems.
  • Proficiency using Microsoft Office.
  • Aseptic technique.
  • Able to multitask.
  • Able to thrive in a fast-paced, start-up environment.

This job involves working under BSL-2 conditions.

 
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.

 
 
Apply to this position