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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IGM Biosciences to Present at Three Upcoming Investor Conferences

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 that Fred Schwarzer, Chief Executive Officer, will present at three upcoming investor conferences:

  • Stifel 2019 Healthcare Conference on Tuesday, November 19 at 4:45 p.m. ET in New York.
  • Jefferies 2019 London Healthcare Conference on Thursday, November 21 at 11:20 a.m. GMT in London.
  • Piper Jaffray 31st Annual Healthcare Conference on Wednesday, December 4 at 3:00 p.m. ET in New York.

A live webcast of the events will be available on the “Events and Presentations” page in the “Investors” section of the Company’s website at https://investor.igmbio.com/news-and-events/events-and-presentations. A replay of the webcasts will be archived on the Company’s website for 90 days following the presentation.

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.

Contact:

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

Scientist/Senior Scientist, In Vivo Pharmacology

Our Preclinical Sciences group is looking for a 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 IND-enabling studies.  You should have a proven track record of conducting animal studies with cynomolgus monkeys and mouse tumor models, as well as working productively as part of a team.  In this position, you will report to the Director, Antibody Pharmacology.

Qualifications:

  • PhD in Immunology/Cancer Biology/Pharmacology or a related scientific discipline with a minimum of 2-5 years of industry experience
  • Proven track record with in vivo animal models for IND-enabling studies, including both monkey and mouse models
  • Hands-on experience conducting efficacy studies with xenograft tumor models in humanized NSG mice (human CD34+ or PBMC engrafted), and syngeneic hematological cancer (i.e. NHL) and solid tumor models
  • Experience interpreting and reporting complex datasets
  • Experience with multi-parametric flow cytometry and general molecular biological techniques including Western blotting, ELISAs, q-PCR etc.
  • Excellent interpersonal and collaborative skills, and the ability to work independently and effectively in a highly dynamic, face-paced environment
  • Experience in hiring, training and supervising direct reports
  • 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

Responsibilities: 

  • Design, execute and interpret preclinical in vivo animal studies in support of multiple programs
  • Maintains familiarity with current disease-relevant in vivo mouse models for testing efficacy and pharmacodynamics of novel biologics to support preclinical development and IND filings
  • Work with collaborators and contract research organizations to execute in vivo animal studies, both cynomolgus monkey and mouse studies
  • Work closely with project teams to conduct in vivo animal studies and write reports and other documents in support of regulatory filings
  • Accountable for in vivo animal model strategy, delivery, communication and follow-up
  • 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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Director of Quality

Our Manufacturing and Process Sciences group is seeking a Director of Quality.  In this role, you will establish a Quality Assurance group to develop, implement, and maintain the company’s CMC quality assurance program to ensure regulatory compliance of all internal GMP functions and external GMP vendors (CMOs, CROs). The successful candidate will also build a Quality Control group to provide leadership, plan, direct, and coordinate in-process testing, finished product release testing and stability programs. This position reports to the VP of Process Sciences and Manufacturing.

Qualifications:

  • Bachelor of Science degree in the Life Sciences/Engineering, or equivalent
  • Minimum 15 years of experience in the Pharmaceutical/Biotech industry or an equivalent combination of education and experience
  • Minimum of 5 years management experience of exempt and non-exempt employees in the Quality Management setting
  • Working knowledge of FDA/EMA cGMP regulations including 21 CFR 210, 211, 820 and ICH guidelines
  • Experience with regulatory inspections, including FDA, EMA and Ministries of Health
  • Experience providing scientific input, data analysis and written reports for failure investigations
  • Practical knowledge and sound understanding of methods development, validation and regulatory submission
  • Effective oral, written, and interpersonal communication skills
  • Must be able to commute to Mountain View

Responsibilities:

  • Build a Quality organization supporting both Quality Assurance and Quality Control with requisite budget and resources to support company’s eventual product commercialization
  • Develop and implement company Quality Systems to ensure compliance with cGMPs and US & EMA regulations, including design control, document control, change control, nonconforming product, manufacturing and production, and CAPA
  • Provide Quality oversight to all cGMP activities, including Drug Substance and Drug product manufacturing, secondary packaging and assembly, and clinical packaging operations
  • Manage and support all quality activities related to the manufacturing and release of clinical product including resolution of investigations and quality issues
  • Responsible for ensuring that all drug substances and drug products are manufactured in accordance with IGM’s specifications, in compliance with cGMP and consistent with applicable regulatory filings
  • Provide quality oversight, review and approve analytical, manufacturing, stability and validation documents including batch records, protocols, procedures, methods, data and final reports
  • Approve and issue specifications, and methods for drug substances and products
  • Conduct risk and gap analyses of existing systems and processes
  • Oversee qualification, performance tracking, and reviews of contract manufacturers, suppliers and laboratories and manage internal and external audits
  • Manages quality investigations at contract manufacturers to ensure that all critical and major quality issues are thoroughly investigated with appropriate corrective actions
  • Review and approve IQ/OQ/PQ and validation protocols, tech transfers and reports, as applicable, for all manufacturing, testing, and packaging activities at all CMO’s
  • Maintain Quality Agreements, and all quality associated documentation files, databases, and logs
  • Responsible for developing and maintaining QC policies and ensure quality and compliance in the QC laboratory
  • Provide effective leadership including setting individual and department objectives, employee evaluations, leading departmental meetings, providing performance feedback, recognizing employee contributions, coaching and developing staff
  • Provide guidance and risk assessment for the resolution of discrepancies, OOS, unexpected results, lab investigations and Corrective and Preventative Actions
  • Oversee all aspects relating to the QC instrumentation program including; purchase, installation, qualification, PM scheduling and trouble shooting
  • Routinely interacts with internal and external colleagues, regulatory agencies, and internal auditors/inspectors

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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Director of Purification

Our Manufacturing and Process Sciences group is seeking a Director of Purification.   In this critical role, you will be responsible for providing technical, managerial and strategic guidance on the delivery of downstream processes in support of novel cancer therapies for clinical studies.  This position reports to the VP of Process Sciences and Manufacturing.

Qualifications:

  • Degree (Ph.D. or M.S.) in Chemistry, Biochemistry, Chemical Engineering or related scientific discipline. Minimum of 10 years of relevant industry experience
  • Minimum of 5 years of management and leadership experience in downstream process development
  • Knowledge of cGMP manufacturing requirements related to clinical production and commercial manufacturing
  • SME in technical operation of chromatography, UF/DF systems and clinical stage formulations.
  • Knowledge of cGMP manufacturing requirements related to clinical production and commercial manufacturing
  • 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
  • Must be able to commute to Mountain View

Responsibilities:

  • Develop and scale-up phase appropriate purification processes for early and late stage process development and validation activities
  • Responsible for tech transfer of purification processes and clinical formulation to external CMO as well as internal manufacturing groups
  • Implement new purification technologies to optimize and streamline processes
  • Transfer and oversee purification process at CMO for GMP manufacturing
  • Review executed batch records from CMO manufacturing
  • Support troubleshooting issues that occur during development, scale-up and in GMP manufacturing
  • Experienced in protein purification techniques including column and membrane chromatography, filtration and tangential flow filtration
  • Working knowledge of AKTA systems and UNICORN programming
  • Strong interpersonal skills and excellent oral and written communication skills
  • Drive process improvement and metric progress in key areas of responsibility: safety/culture, quality/delivery, cost-effectiveness, and efficiency
  • 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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IGM Biosciences Announces Third Quarter 2019 Financial Results

MOUNTAIN VIEW, Calif., Nov. 7, 2019 — 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