IGM Biosciences Appoints Eric Humke, M.D., Ph.D., as Vice President, Clinical Development, Apoptosis

Expert in the research and development of apoptotic pathways and antibody drug conjugates.

MOUNTAIN VIEW, Calif., January 7, 2020IGM Biosciences, Inc. (Nasdaq: IGMS), a global leader in the research and development of engineered therapeutic IgM antibodies, today announced the appointment of Eric Humke, M.D., Ph.D., to the newly created position of Vice President, Clinical Development, Apoptosis. Dr. Humke will join Daniel S. Chen, Chief Medical Officer, and Wayne Godfrey, Vice President, Clinical Development, to lead the global clinical development of IGM’s emerging pipeline of proprietary IgM antibodies.

“Eric’s experience in developing numerous first-in-human therapeutics in multiple cancer indications, including several different antibody drug conjugates, will provide strong support for the expansion of the clinical development of our industry-leading IgM technology platform,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences.

Dr. Humke commented, “Apoptotic, also known as programmed cell death, pathways are highly conserved throughout evolution, and evasion of cell death is absolutely fundamental to the formation of cancer. Targeting of these pathways may have immense therapeutic potential for treating cancer and needs to be realized.  I believe IGM’s innovative and proprietary approach to engineering and producing IgM-based agonists is an excellent match for this biology, and I am extremely excited to have the opportunity to build and lead the clinical research and development efforts in apoptosis at IGM Biosciences.”

Dr. Humke joins IGM with more than 15 years of experience in apoptosis research and early clinical development of first-in-human therapeutics in solid tumors, most recently serving as Senior Medical Director at Genentech. While at Genentech, he led multiple clinical investigation programs in Research & Early Clinical Development, including the study of six different antibody drug conjugates in lung, ovarian, and endometrial cancer, as well as multiple myeloma. Prior to joining Genentech, he was an Instructor of Medicine in the Division of Oncology at the Stanford University School of Medicine where he conducted research and clinical studies.

“Eric studied apoptosis biology with Vishva Dixit at the University of Michigan and at Genentech, during a time when they discovered and characterized many of these critical pathways, including death receptor 5 (DR5). Those early studies performed by Dr. Humke and others in the Dixit lab represents the foundation of our understanding of these critical cellular death and survival factors for cancer. However, therapeutic technologies needed to optimally target trimerizing Tumor Necrosis Super Family Receptors (TNSFRs) such as DR5 have been lacking,” said Daniel S. Chen, Chief Medical Officer of IGM Biosciences. Dr. Chen continued, “With our multimerizing IgM anti-DR5 agonists, we look forward to Eric leveraging his depth of apoptotic scientific expertise and early clinical development experience in solid tumor indications to lead these programs and further extend IGM’s clinical development capabilities.”

Dr. Humke has co-authored multiple clinical and scientific publications and book chapters. He earned a B.S. at Brown University and an M.D., Ph.D. from the University of Michigan. He completed his internal medicine residency at Washington University in St. Louis (Barnes-Jewish Hospital) and a medical oncology fellowship at Stanford University.

About IGM Biosciences, Inc.

Headquartered in Mountain View, California, IGM Biosciences is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies for the treatment of cancer patients. Since 2010, IGM Biosciences has worked to overcome the manufacturing and protein engineering hurdles that have limited the therapeutic use of IgM antibodies. Through its efforts, IGM Biosciences has created a proprietary IgM technology platform for the development of IgM antibodies for those clinical indications where their inherent properties may provide advantages as compared to IgG antibodies.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or IGM Biosciences’ future plans, strategy and performance. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially, including those more fully described in IGM Biosciences’ filings with the Securities and Exchange Commission (“SEC”), including IGM Biosciences’ Quarterly Report on Form 10-Q filed with the  SEC on November 7, 2019 and in IGM Biosciences’ future reports to be filed with the SEC.  Any forward-looking statements contained in this press release speak only as of the date hereof, and IGM Biosciences specifically disclaims any obligation to update any forward-looking statement, except as required by law.

Contact:

Argot Partners
David Pitts
212-600-1902
igmbio@argotpartners.com

Sr. AP Specialist

We are seeking for a senior accounts payable specialist to join our growing accounting team. In this position, you will have the opportunity to own the accounts payable process from beginning to end. This position will directly report to the Corporate Controller.

Responsibilities:

  • Perform full cycle accounts payable processes in a high volume, fast-paced environment.
  • Process vendor invoices for three-way matching of tangible goods invoices; obtain proper payment approval.
  • Record invoices to the proper accounting periods in accordance with company policy and generally accepted accounting principles.
  • Ensure proper GL coding of invoices and expenses with proper documentation and approval.
  • Work closely with Purchasing team to resolve invoice/PO discrepancies.
  • Monitor the Accounts Payable inbox to ensure that all invoices and other vendor communication are properly addressed.
  • Prepare and perform weekly ad-hoc check runs and electronic payments.
  • Perform the accounts payable monthly close process including preparing accrual journal entries and account reconciliations.
  • Manage annual 1099 reporting.
  • Maintain effective accounts payable policies, procedures and internal controls.
  • Assist with financial and tax audits as needed.
  • Administration of the T&E system.
  • Proactively identify and assist with process improvements.
  • Assist with other ad-hoc requests and duties as assigned.

Qualifications:

  • Bachelor’s degree in Accounting, Finance or related field with at least 5 years of relevant work experience in an accounts payable function (experience in the biotech a plus).
  • Intermediate Excel skills while proficient in other Microsoft tools (Outlook, Word, PowerPoint, etc.) required.
  • Public company experience required.
  • Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
  • Ability to work independently and as part of a team.
  • Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
  • Able to work with a high volume of transactions in a fast-paced environment.
  • Must be 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.

 
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Executive Assistant

In this integral new position at IGM as an Executive Assistant, you will provide senior level administrative support to our CSO, CMO, CEO, and CFO. In this highly visible role, you will handle details of a confidential nature, and must always be able to maintain professional and ethical standards.

Responsibilities:

  • Proactively manage calendars and schedules.
  • Coordinate meeting logistics both internally and externally.
  • Be responsive to requests for assistance from and communicate professionally with members of the board.
  • Coordinate logistics with respect to board meetings.
  • Email management.
  • Coordinate all aspects of travel arrangements.
  • Assist with documentation preparation, such as presentations and reports.
  • Conduct routine administrative duties as necessary.

Qualifications:

  • 5+ years supporting senior management as an Executive Assistant.
  • Extremely well organized.
  • Able to multi-task.
  • Proficient in the Microsoft Office Suite.
  • Familiarity with Concur is helpful.
  • Excellent oral and written skills.
  • Strong decision-making skills.
  • Must be able to navigate ambiguity with limited guidance.
  • Must be able to work with employees at all levels at IGM.
  • Able to manage competing priorities.
  • Must enjoy working in a fast paced, entrepreneurial environment.
  • Prior experience in life sciences/biotech is helpful.

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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Research Associate / Senior Research Associate, Biomarkers

Our Preclinical Sciences group is looking for a Research Associate with a background in Immunology, Cell Biology or a related scientific discipline to join our growing and friendly team during this exciting time in our expansion. You will play an integral role in the preclinical development of novel antibody-based therapeutics in a variety of disease areas and at various stages of development.

Responsibilities:

  • Human and mouse cell culture and primary cell maintenance and isolation.
  • Design, develop and execute in vitro cell-based immunoassays.
  • Perform analysis with ELISAs other methods of cytokine/analyte analysis.
  • Utilize multicolor flow cytometry in analysis.
  • Execute basic biochemical assays (eg. Western blot).
  • Communicate own work effectively orally and in writing; present data in group meetings.
  • Thoroughly and accurately document experimental activities in laboratory notebooks.

Qualifications:

  • BS or higher degree in Immunology, Cell Biology or related scientific discipline.
  • 3-5 + years of relevant industry or academic experience.
  • Must have hands-on experience in multi-color flow cytometry, and in vitro cell-based immunoassays.
  • Experience evaluating T cell engagers and other antibody therapeutics is a plus.
  • Proficient with basic computer programs routinely used in a lab such as MS Word, Excel, and PowerPoint, GraphPad Prism, and FlowJo.
  • Highly organized with reliable time-keeping skills and able to maintain a detailed and well-organized notebook.
  • Must be a team player, respectful of others, and have strong interpersonal and communication skills.
  • 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.

 
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Upstream Manufacturing Manager

We are hiring a Manager for the Upstream Manufacturing group to join our rapidly growing team. In this important position, you will build and manage a team to execute CHO based cell culture processes following GMP guidance, generating clarified Harvested Cell Culture Fluid (HCCF) to be used for further manufacturing by the Downstream manufacturing team. This role will also include a close working relationship with the Process Development team to perform technology transfer of multiple molecules to support GMP level manufacturing. These efforts are all focused to help advance novel cancer therapies into human clinical studies.

Responsibilities:

  • Experience with operating benchtop bioreactors, pilot scale bioreactors and mini bioreactors such as AMBR250 preferred but not required.
  • Scale up cell culture processes to a 1000 L disposable stirred tank bioreactor.
  • Collaborate closely with Upstream and Downstream development, Downstream manufacturing and Quality groups to meet project timelines.
  • Lead the technology transfer of cell culture processes from the development group into GMP manufacturing.
  • Enhance cell culture process understanding and participate in platform optimization efforts.
  • Expertise with media/feed optimization and perfusion cultures is a plus.
  • Write clear and concise Standard Operating Procedures (SOP’s), Production Documents and forms/addenda to facilitate GMP manufacturing.
  • Perform timely production reviews on operator completed GMP documentation and batch records.
  • Contribute to GMP campaign summary reports, relevant CMC sections in regulatory filings and technical development reports.
  • Hire train and develop an efficient well-developed upstream operations team.
  • Manage and evaluate the team holding direct reports accountable for performance.
  • Partner with Quality and Safety to ensure best efforts compliance.
  • Drive process improvement and metric progress in key areas of responsibility: safety/culture, quality/delivery, cost-effectiveness, efficiency.
  • Support the Request For Proposal (RFP) and diligence process for all external manufacturing contracts.

Qualifications:

  • B.S. degree in Engineering, Life Science or related field, and 5+ years in manufacturing biologics under GMP to support FDA/EMA approved clinical trials.
  • Minimum of 2 years of management and leadership experience.
  • Knowledge of GMP manufacturing requirements related to clinical production and commercial manufacturing of injectable products.
  • Lean Manufacturing implementation experience preferred.
  • Experience operating single use upstream manufacturing processes considered a plus.
  • Strong leader and mentor.
  • Excellent verbal and written communication.
  • Proficiency using Microsoft Office, relational databases, cloud-based document control systems (i.e. TrackWise, Veeva, Master Control etc.) and graphing programs.
  • Aseptic technique.
  • Able to multitask.
  • Extremely well organized with great attention to detail.
  • Able to thrive in a fast-paced, start-up environment.
  • “Roll up the sleeves” mentality.
  • Must be able to commute to Mountain View, CA.

Working environment:

  • This job involves working under BSL-1 conditions.
  • Capable of lifting upwards of 50 pounds infrequently.

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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Research Associate/Senior Research Associate, Cell-line Development

We are seeking a SA/SRA with a background in cell-line development or with the skills to readily contribute to engineering and selecting world class IgM producing cell lines.

Responsibilities:

  • Actively contribute to development of stable cell lines for clinical trials.
  • Optimization of robust high throughput cell screening platform technology for efficient selection of high producing cell lines.
  • Stable/transient plasmid transfection of suspension/adherent mammalian cell cultures.
  • Design and conduct upstream production experiments.
  • Develop and conduct molecular assays for producer cell line analysis.
  • Ensure high-quality, timely documentation in electronic laboratory notebooks and technical reports and contribute to regulatory filings.
  • Work as part of a cross-functional team.

Qualifications:

  • BS or MS in Cell Biology, Molecular Biology, Biochemistry, Chemical/Biochemical Engineering, or related field with 3-5 years of industry experience.
  • Experience with mammalian cell culture, and transient and stable expression techniques.
    SDS-PAGE, ELISA, qPCR, western blot, Octet.
  • Ability and desire to work in a fast-paced, multi-project environment.
  • Strong collaboration, team-working skills and communication skills.
  • Independently motivated and detail-oriented with good problem-solving ability.
  • Hands on experience in design and execution of key activities associated with cell line. generation and workflow optimization; including transfection, drug selection, verifiable single cell cloning, high throughput clone/pool screening, cell banking and clone analysis.
  • Flow cytometry assay experience.
  • Able to thrive in a fast-paced, start-up environment.
  • Must be 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.

 
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RA/SRA Downstream

We are seeking a Research Associate or Senior Research Associate with experience in process development, particularly in the context of antibody and antibody-like biologics. The ideal candidate will have a solid background in protein purification and bioanalytical techniques used to characterize biologics. This is a key position in the Process Sciences and Manufacturing group and will have the opportunity to collaborate across groups to contribute to multiple fast-moving drug discovery projects.

Responsibilities:

  • Maintain downstream process lab.
  • Keep track of inventory records of supplies, materials, and prepare requisitions as necessary.
  • Determine expression titer by ELISA and other techniques.
  • Perform protein and antibody purification by chromatography and filtration technology.
  • Characterize protein and antibody targets using typical analytical methods in protein chemistry.
  • Document results in laboratory notebooks.
  • Share data with management and team members.
  • Research literature to identify alternative methodologies and solve scientific problems, establish, and qualify assays.
  • Prepare technical reports, summaries of testing, and detailed protocols.
  • Learn new techniques as the job requires.

Qualifications:

  • BS/BA degree in Biology, Biochemistry, or chemical engineering background or related fields with three (3) or more years of experience in biopharma industry, preferably in a fast-paced startup environment.
  • Experience in protein purification using a variety of chromatographic techniques with hands-on experience using and maintaining AKTA FPLC (AVANT, Pure, Ready) systems with Unicorn software.
  • Prior experience interacting with CROs/CMOs for manufacturing and characterizing biologics.
  • Experience with tangential flow filtration.
  • Demonstrated experience with analytics and characterization of proteins and antibodies (SDS-PAGE, Western Blot, residual Host Cell Proteins, residual DNA, HPLC).
  • Ability to evaluate purification processes for scalability, cost and quality and then transfer to CMO.
  • Experience with designing and performing DOEs is a plus.
  • Good understanding of biophysical techniques such as DSC, DLS, and IEF is preferred.
  • Excellent organization, interpersonal, and communication skills and ability to clearly and effectively present data at group and company meetings.
  • Being a consummate team player and respectful of others is a must.
  • Must be 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.

 
 
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Downstream Scientist/Sr. Scientist

We are seeking a Scientist or Senior Scientist with significant experience in process development particularly in the context of antibody and antibody-like biologics. The ideal candidate will have a solid background in protein purification and bioanalytical techniques used to characterize biologics. This is a key position in the Process Sciences and Manufacturing group and will have the opportunity to collaborate across groups to contribute to multiple fast-moving drug discovery projects.

Responsibilities

  • Operate and maintain instrumentation for the analysis and purification of antibodies.
  • Develop and perform protein and antibody purification by chromatography and filtration technology.
  • Tech transfer purification processes to internal and/or external manufacturing groups.
  • Characterize protein and antibody targets using typical analytical methods (SDS-PAGE, SEC, endotoxin, etc.).
  • Keep accurate and current records of research and/or project related activities in laboratory notebooks.
  • Prepare technical reports, summaries of testing, and detailed protocols.
  • Share data with management and team members.
  • Research literature to identify novel methodologies and solve scientific problems and apply to the overall program.
  • Publish research in peer-reviewed journals and present work at scientific conferences when possible.
  • May supervise one or more direct reports and proactively engage in their development.

Qualifications

  • Ph.D. degree biology, biochemistry, chemical engineering or related fields with at least two (2) years of experience or Bachelor/Master’s with more than five (5) years of post-degree experience in the biopharma industry, preferably in a fast-paced startup environment.
  • Extensive experience in protein purification using a variety of chromatographic techniques with hands-on experience using and maintaining AKTA FPLC (AVANT, Pure, Ready) systems with Unicorn software.
  • Prior experience interacting with CROs/CMOs for manufacturing and characterizing biologics.
  • Experience with viral and tangential flow filtration.
  • Demonstrated experience with analytics and characterization of proteins and antibodies (SDS-PAGE, Western Blot, residual Host Cell Proteins, residual DNA, HPLC).
  • Ability to evaluate purification processes for scalability, cost and quality and then transfer to CMO.
  • Experience with designing and performing DOE is a plus.
  • Good understanding of biophysical techniques such as DSF, DSC, DLS, IEF is preferred.
  • Ability to work independently or with limited direct supervision.
  • Excellent organization, interpersonal, and communication skills and ability to clearly and effectively present data at group and company meetings
  • Consummate team player and respectful of others is a must.
  • Must be 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.

 
 
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Downstream Manufacturing Manager

We are hiring a Manager for the Downstream Manufacturing group to join our rapidly growing team. In this important position, you will build and manage a team to execute monoclonal antibody based downstream processes following GMP guidance, generating bulk drug substance to be used for further manufacturing by contracted fill and finish organizations. This role will also include a close working relationship with the Process Development team to perform technology transfer of multiple molecules to support GMP level manufacturing. These efforts are all focused to help advance novel cancer therapies into human clinical studies.

Responsibilities:

  • Experience with operating ÄKTA purification systems and UNICORN 7 (or equivalent) required.
  • Expertise and understanding of large protein molecule/monoclonal antibody separation and impurity clearance from harvested cell culture fluid, based on size, physico-chemical properties and binding affinity.
  • Experience with packing and unpacking multiple types of resins/media to perform capture, elution and polishing required.
  • Experience with operating TFF/UFDF skids and viral inactivation and filtration required.
  • Collaborate closely with Upstream and Downstream development, Upstream manufacturing and Quality groups to meet project timelines.
  • Lead the technology transfer of purification processes from the development group into GMP manufacturing.
  • Enhance antibody purification process understanding and participate in platform optimization efforts.
  • Write clear and concise Standard Operating Procedures (SOP’s), Production Documents and forms/addenda to facilitate GMP manufacturing.
  • Perform timely production reviews on operator completed GMP documentation and batch records.
  • Contribute to GMP campaign summary reports, relevant CMC sections in regulatory filings and technical development reports.
  • Hire, train and develop an efficient well-developed downstream operations team.
  • Manage and evaluate the team holding direct reports accountable for performance.
  • Partner with Quality and Safety to ensure best efforts compliance.
  • Drive process improvement and metric progress in key areas of responsibility: safety/culture, quality/delivery, cost-effectiveness, efficiency.
  • Support the Request For Proposal (RFP) and diligence process for all external manufacturing contracts.

Qualifications:

  • B.S. degree in Engineering, Life Science or related field, and 5+ years in manufacturing biologics under GMP to support FDA/EMA approved clinical trials.
  • Minimum of 2 years of management and leadership experience.
  • Knowledge of GMP manufacturing requirements related to clinical production and commercial manufacturing of injectable products.
  • Lean Manufacturing implementation experience preferred.
  • Experience operating single use downstream manufacturing processes considered a plus
  • Strong leader and mentor.
  • Excellent verbal and written communication.
  • Proficiency using Microsoft Office, relational databases, cloud-based document control systems (i.e. TrackWise, Veeva, Master Control etc.) and graphing programs.
  • Aseptic technique.
  • Able to multitask.
  • Extremely well organized with great attention to detail.
  • Able to thrive in a fast-paced, start-up environment.
  • “Roll up the sleeves” mentality.
  • Must be able to commute to Mountain View, CA.

Working environment:

  • This job involves working under BSL-1 conditions.
  • Capable of lifting upwards of 50 pounds infrequently.

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, Sr. Scientist In Vivo Models

Our Immuno-Oncology group is looking for an in vivo Scientist/Senior Scientist with a strong background in Immunology, Immuno-Oncology, Pharmacology or a related scientific discipline to join our growing and friendly team during this exciting time in our expansion. You will play an integral role in the preclinical development of novel antibody-based therapeutics in a variety of disease areas and at various stages of development.

We are looking for candidates that are highly skilled, motivated and creative scientists with hands-on experience with in vivo animal models for pre-clinical studies. You should have a proven track record of conducting animal studies with humanized mouse and syngeneic tumor models, as well as working productively as part of a team. In this position, you will report to the VP Immuno-Oncology.

Qualifications:

  • PhD or MSc in Immunology/Cancer Biology/Pharmacology or a related scientific discipline with a minimum of 5 years’ experience required, preferably in industry.
  • Proven track record in in vivo model development, particularly in context of cancer and immunology, required.
  • Hands-on experience conducting PD and efficacy studies with xenograft tumor models in humanized NSG mice (human CD34+ , T cell or PBMC engrafted), and syngeneic hematological cancer and solid tumor models required.
  • Experience with multi-parametric flow cytometry required.
  • Experience in hiring, training and supervising direct reports required.
  • Proven record of following IACUC regulations and close monitoring of animal health required.
  • Ability to write and manage IACUC protocols with local CROs and experience in managing CROs preferred.
  • Excellent interpersonal and collaborative skills, and the ability to work independently and effectively in a highly dynamic, face-paced environment.
  • Highly organized with reliable time-keeping skills and able to maintain a detailed and well-organized notebook.
  • Must be a team player, respectful of others, and have strong interpersonal and communication skills.

Responsibilities:

  • Design, execute and interpret preclinical in vivo animal studies in support of multiple programs.
  • Work with multiple internal teams, collaborators and contract research organizations to execute in vivo mouse studies.
  • Keep up-to-date with developments in current disease-relevant in vivo mouse models for testing efficacy and pharmacodynamics of novel biologics to support preclinical development.
  • Accountable for in vivo animal model strategy, delivery, communication and follow-up.
  • Management of a team of Associates to execute studies.
  • Presentation of results at internal and external meetings.

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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