Director of Analytical Development and Formulation

Our Manufacturing and Process Sciences group is seeking a Director of Analytical and Formulation.   In this critical role, you will be responsible for providing technical, managerial and strategic guidance on the delivery of stable clinical formulations and analytical methods for drug substance and drug product release and characterization.  This position reports to the VP of Process Sciences and Manufacturing.

Qualifications:

  • Degree (PhD) in Analytical Chemistry, Biochemistry, Molecular Biology or related scientific discipline. Minimum of 10 years of relevant industry experience
  • Minimum of 5 years of management and leadership experience in Analytical Development and Formulation including a commitment to mentorship and development of personnel
  • Requires a strong background in Formulation and Analytical Development, as well as a knowledge of cGMPs, ICH, and relevant FDA guidelines and experience in writing relevant regulatory submissions
  • Experience in IND-enabling stability study design and management is preferred
  • Proficiency in hands on analytical work while managing internal and external activities
  • Demonstrated ability to work independently across functional areas to design assays that can be implemented in a quality control lab
  • Excellent communication skills are required
  • 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

Responsibilities:

  • Design and develop clinical stage formulations for IgM and IgA antibodies
  • Lead assay development activities, including method qualifications and transfers, required for clinical stage molecules
  • Provide input and data for regulatory filings
  • 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
  • Manage a team of direct reports including lead scientists
  • Support troubleshooting issues that occur during development, scale-up and in GMP manufacturing
  • 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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Patent Agent/Attorney

We are seeking an experienced patent agent/attorney to help manage our growing patent portfolio. In this important position you will use your scientific and legal skills to develop and implement patent strategies in coordination with the legal team, and to identify and communicate risks. This position will directly report to our VP, Intellectual Property.

Qualifications:

  • Patent Agent or Attorney with USPTO Registration Number.
  • 4+ years of experience in preparing and prosecuting patent applications in a molecular biology-related field, either in-house or in a law firm.
  •  Ph.D. or equivalent in a molecular biology-related field, or B.S. or M.S. plus 6+ years of relevant laboratory experience.
  • Experience working in the biotechnology industry.
  • High level of professionalism and motivation, ability to work independently but also as part of a team.
  • Able to take initiative to identify and complete tasks.
  • Able to manage multiple projects with rapidly changing priorities.
  • Excellent writing and communication skills.
  • Exemplary time management skills, organization, and attention to detail.
  • Must be able to commute to Mountain View.

Responsibilities:

  • Actively coordinate with our research and development teams to identify new inventions as well as to devise and implement strategies for patent protection over the life cycle of product candidates.
  • Prepare and prosecute US patent applications.
  • Assist in the development of coordinated global patent strategies.
  • Perform freedom to operate and patentability searches.
  • Evaluate and monitor patent portfolios of third parties.
  • Communicate IP guidance to IGM management.

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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IGM Biosciences Announces Third Quarter 2019 Financial Results

MOUNTAIN VIEW, Calif.,  — IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies for the treatment of cancer patients, today announced its financial results for the third quarter ended September 30, 2019 and provided an update on recent developments.

“During the third quarter of 2019, we continued to make progress towards our research, clinical development and financing goals, including initiating our first-in-human clinical trial of our lead IgM antibody, IGM-2323, in patients with relapsed/refractory B cell Non-Hodgkin’s lymphoma and closing both our Series C financing and our initial public offering,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. “During 2020, we hope to continue our progress and report initial data from our IGM-2323 Phase 1 trial and file an IND for our second product candidate, an IgM antibody targeting DR5.”

Recent Highlights

Initiated Phase 1 clinical trial of IGM-2323. In October 2019, IGM announced dosing of the first patient in its Phase 1 clinical trial evaluating IGM-2323 in patients with relapsed/refractory B cell Non-Hodgkin’s lymphoma (NHL). This Phase 1 clinical trial represents the first-in-human application of IGM Biosciences’ engineered IgM antibody technology. The Company expects to report initial data from this Phase 1 trial in the second half of 2020.

Completed initial public offering (IPO) and Series C financing. In September 2019, IGM closed its IPO of 12,578,125 shares of its common stock at a price to the public of $16.00 per share, which included the exercise in full by the underwriters of their option to purchase up to 1,640,625 additional shares. IGM received gross proceeds of $201.3 million from the offering. Prior to the IPO, in July 2019, IGM completed a $102 million Series C financing which included conversion of $20 million in unsecured promissory notes. In aggregate, IGM raised $264.5 million in cash proceeds pursuant to these financings, net of note conversion, underwriting discounts and commissions and estimated offering expenses.

Third Quarter 2019 Financial Results

Cash and Investments: Cash and investments as of September 30, 2019 were $251.3 million.
Research and Development (R&D) Expenses: For the third quarter of 2019, R&D expenses were $8.3 million.
General and Administrative (G&A) Expenses: For the third quarter of 2019, G&A expenses were $2.4 million.
Net Loss: For the third quarter of 2019, net loss was $10.2 million, or a loss of $2.41 per share.
Shares outstanding: Shares outstanding as of September 30, 2019 were 30.5 million including both voting common stock and non-voting common stock.

Financial Guidance

Management estimates operating expenses for 2019 of approximately $42.0 – $45.0 million, including estimated stock-based compensation expense of approximately $1.0 million. Management also expects a balance of over $230 million in cash and investments and approximately 30.6 million shares outstanding, including both voting common stock and non-voting common stock, at December 31, 2019.

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 financial or operating performance. Such forward-looking statements include, but are not limited to, statements regarding the Company’s Phase 1 clinical trial of IGM-2323, the potential of, and expectations regarding, the Company’s IgM technology platform, the timing of reporting initial data from the IGM-2323 Phase 1 clinical trial, the timing of filing an IND for the Company’s second product candidate, estimated 2019 operating expenses and stock-based compensation expense, estimated balance of cash and investments and number of shares outstanding as of December 31, 2019, and statements by the Company’s Chief Executive Officer. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially, including but not limited to: IGM Biosciences’ ability to accurately forecast financial results; IGM Biosciences’ early stages of clinical drug development; uncertainties related to the use of engineered IgM antibodies, which is a novel and unproven therapeutic approach; IGM Biosciences’ ability to advance product candidates into, and successfully complete, clinical trials on the timelines it projects; IGM Biosciences’ ability to adequately demonstrate sufficient safety and efficacy of its product candidates; IGM Biosciences’ ability to enroll patients in its ongoing and future clinical trials; IGM Biosciences’ ability to successfully manufacture and supply its product candidates for clinical trials; IGM Biosciences’ ability to obtain additional capital to finance its operations; uncertainties related to the projections of the size of patient populations suffering from the diseases IGM Biosciences is targeting; IGM Biosciences’ ability to obtain, maintain, and protect its intellectual property rights; developments relating to IGM Biosciences’ competitors and its industry, including competing product candidates and therapies; general economic and market conditions; and other risks and uncertainties, 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

IGM Biosciences Initiates First-in-Human Phase 1 Clinical Trial of IGM-2323 for the Treatment of Relapsed/Refractory B Cell Non-Hodgkin’s Lymphoma

MOUNTAIN VIEW, Calif., Oct. 02, 2019 — IGM Biosciences, Inc. (Nasdaq: IGMS), a biotechnology company focused on creating and developing engineered IgM antibodies for the treatment of cancer patients, today announced that the first patient has been dosed in its Phase 1 clinical trial evaluating IGM-2323, the Company’s CD20 x CD3 bispecific IgM antibody, in patients with relapsed/refractory B cell Non-Hodgkin’s lymphoma (NHL).

This Phase 1 clinical trial represents the first in-human application of IGM Biosciences’ engineered IgM antibody technology. The Phase 1 multi-center, open label trial is intended to assess the safety, pharmacokinetics and preliminary efficacy of intravenous IGM-2323 in patients with relapsed/refractory B cell NHL. IGM-2323 will initially be administered at a planned fixed-dose, as part of a dose escalation protocol.

About IGM Biosciences, Inc.

Headquartered in Mountain View, California, IGM Biosciences is a 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 IGMBiosciences’ future financial or operating performance. Such forward-looking statements include, but are not limited to, statements regarding the Company’s Phase 1 clinical trial of IGM-2323. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially, including but not limited to:  IGM Biosciences’ early stages of clinical drug development;  uncertainties related to the use of engineered IgM antibodies, which is a novel and unproven therapeutic approach; IGM Biosciences’ ability to advance product candidates into, and successfully complete, clinical trials on the timelines it projects; IGM Biosciences’ ability to adequately demonstrate sufficient safety and efficacy of its product candidates; IGM Biosciences’ ability to enroll patients in its ongoing and future clinical trials; IGM Biosciences’ ability to successfully manufacture and supply its product candidates for clinical trials; IGM Biosciences’ ability to obtain additional capital to finance its operations; uncertainties related to the projections of the size of patient populations suffering from the diseases IGM Biosciences is targeting; IGM Biosciences’ ability to obtain, maintain, and protect its intellectual property rights; developments relating to IGM Biosciences’ competitors and its industry, including competing product candidates and therapies; general economic and market conditions; and other risks and uncertainties, including those more fully described in IGM Biosciences’ filings with the Securities and Exchange Commission (“SEC”), including IGM Biosciences’ prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, dated September 17, 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

IGM Biosciences Announces Closing of Initial Public Offering, Including Full Exercise of Underwriters’ Option to Purchase Additional Shares

MOUNTAIN VIEW, Calif., Sept. 20, 2019 — IGM Biosciences, Inc. (Nasdaq: IGMS) today announced the closing of its initial public offering of 12,578,125 shares of its common stock at a price to the public of $16.00 per share, which includes the exercise in full by the underwriters of their option to purchase up to 1,640,625 additional shares. The shares began trading on The Nasdaq Global Select Market on September 18, 2019 under the symbol “IGMS.” IGM received gross proceeds, before deducting underwriting discounts and commissions and estimated offering expenses, of approximately $201.3 million.

Jefferies, Piper Jaffray, Stifel and Guggenheim Securities acted as joint book-running managers for the offering.

A registration statement relating to the offering was declared effective by the United States Securities and Exchange Commission on September 17, 2019. The offering was made only by means of a prospectus. A copy of the final prospectus relating to this offering may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at Prospectus_Department@Jefferies.com; Piper Jaffray & Co, Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924 or by email at prospectus@pjc.com; Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at syndprospectus@stifel.com; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison, 8th Floor, New York, NY 10017, by telephone at (212) 518-9658 or by email at GSEquityProspectusDelivery@guggenheimpartners.com.

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful before registration or qualification under the securities laws of that state or jurisdiction.

About IGM Biosciences, Inc.

Headquartered in Mountain View, California, IGM Biosciences is a 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.

Contact

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

Senior Research Associate, Discovery Biology

We are seeking a Senior Research Associate in the Discovery Group with a background in immunological, biochemical, and protein chemistry techniques. In this important position, you should have a good understanding of human and mouse immune systems, extensive experience in various immunological assays such as recall antigen assay, mixed lymphocyte reaction assay etc. You should also have experience with small scale protein production, purification and characterization. Experience with high throughput cell-based assays and assay automation with liquid handling robots is also highly desired.

Qualifications:

  • Master’s degree in biological sciences or related field with 2 years’ experience, or Bachelor’s degree (BS) with 4 years’ experience in biotech industry.
  • Familiar with human and mouse immune systems. Hands on experience with various immunological assays such as T cell activation assays, cytokine release assays, recall antigen assay, and mixed lymphocyte reaction assay, etc. Extensive experience in multi-color flow cytometry is required.
  • Experience with mammalian cell culture and transfection, protein purification and characterization (SDS-PAGE, ELISA, western blots, Endotoxin assays, etc.).
  • Experience with high throughput cell-based assays with imaging and flow cytometry readouts, and assay automation using liquid handling robots is highly desired.
  • 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.
  • Must be able to commute to Mountain View.

Responsibilities:

  • Perform small scale protein production, purification and characterization (SDS-PAGE, ELISA, western blots, Endotoxin assays, etc.) of candidate antibodies to support multiple therapeutic IgM projects.
  • Isolate PBMCs and immune cell subsets from buffy coat or whole blood samples. Perform in vitro functional assays such as cytotoxicity assays, T cell activation assays, cytokine release assays, recall antigen assay, and mixed lymphocyte reaction assay to evaluate candidate antibodies.
  • Perform ELISA and flow cytometry assays to analyze ex vivo samples from PK/PD animal studies, including PK ELISAs, cytokine analysis, immunophenotyping, etc.
  • Perform data analysis and generate technical reports. Ensure high-quality and timely documentation in electronic lab notebooks.

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.