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

Lab Assistant, Laboratory Operations

We are seeking a Lab Assistant with a background in operations.  In this important position, you will support the Lab Operations group primarily in performing a variety of tasks in support of our researchers.

Responsibilities:

  • Adhere to the laboratory’s operation policies
  • Participate in laboratory support work as required by the team needs and at the direction of laboratory management
  • Lead the general upkeep, orderliness and cleanliness of the laboratory
  • Carry out daily/weekly/monthly maintenance schedules to ensure that laboratory equipment is operating properly
  • Organize and monitor lab supplies, consumables, reagents and materials
  • Monitor and consolidate laboratory wastes as needed
  • Assist Receiving with daily deliveries and reconciliations
  • Track and report all lab incidents
  • Keep chemical and SDS inventory up to date
  • Be an active participant in compliance and safety walkthroughs and audits
  • Other duties as may be determined by Management

Qualifications: 

  • Bachelor’s degree (BS) with experience, preferably in a startup biotech environment
  • Must have exceptional attention to detail
  • Ability to read, interpret, and comply with documents such as internal SOPs, operating and maintenance instructions, and company policies
  • Must be comfortable with hazardous waste handling
  • 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
  • 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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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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Scientist/Senior Scientist, Immunoassays

Our Preclinical Sciences group is looking for a Scientist/Senior Scientist with a strong background in Immunology, Molecular Biology, Biochemistry, 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 in developing assays to quantitate therapeutic antibody levels, anti-drug antibodies and pharmacodynamic measures of activity utilizing immunoassays and/or other methodologies.  Candidates should have a proven track record of solving complex bioanalytical problems and working productively as part of a team.  In this position, you will report to the Director, Antibody PK/PD.

Qualifications: 

  • PhD in Immunology/Molecular Biology/Biochemistry or a related scientific discipline with a minimum of 2-5 years of industry experience
  • Proven track record of solving complex bioanalytical problems
  • Hands-on experience developing assays to quantitate drug levels, anti-drug antibodies, and pharmacodynamic measures of activity using immunoassays and/or other methodologies
  • Experience with multiple immunoassay platforms and technologies, including ELISA, MSD, and Luminex
  • Experience interpreting and reporting complex immunogenicity data
  • Experience with 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 environment
  • Experience 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 have strong interpersonal and communication skills
  • Being a team player and respectful of others is a must
  • Able to thrive in a fast-paced environment
  • Able to commute to Mountain View

Responsibilities: 

  • Develop, characterize, qualify and implement methods to quantify the levels of biotherapeutics in various species and biological matrices
  • Develop and implement anti-drug antibody assays and strategies; provide guidance in interpretation and reporting of immunogenicity datasets
  • Work with collaborators and contract research organizations to transfer and validate such assays
  • Work closely with project teams to conduct biological characterization and write reports and other documents in support of regulatory filings
  • Accountable for project 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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Scientist/Senior Scientist, Biomarkers

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 in developing assays to identify candidate pharmacodynamic and predictive biomarkers in both solid and hematological cancers across multiple projects.  You  should have a proven track record of biomarker assay development and working productively as part of a team.  You will be responsible for biomarker identification and characterization in preclinical studies, implementation of state-of-the-art biomarker methods, and analysis and interpretation of biomarker data to guide early clinical development. 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 of biomarker assay development, qualification and implementation
  • Hands-on experience developing assays to evaluate candidate biomarkers in nonclinical models and selecting optimal assays for clinical evaluation
  • Experience interpreting and reporting complex datasets
  • Experience with multiparametric flow cytometry and immunohistochemistry analyses, and general expertise in immunosequencing, and gene expression and proteomic technologies
  • Excellent interpersonal and collaborative skills, and the ability to work independently and effectively in a highly dynamic, fast-paced environment
  • Experience 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: 

  • Develop, qualify and implement methods to identify candidate pharmacodynamic and predictive biomarkers in nonclinical models
  • Integrate and interpret preclinical biomarker data for successful cross-functional transfer to clinical biomarker colleagues
  • Maintains a high level of professional expertise through familiarity with new technologies for biomarker discovery within immuno-oncology
  • Work with collaborators and contract research organizations to transfer and qualify biomarker assays
  • Work closely with project teams to conduct biomarker assays and write reports and other documents in support of regulatory filings
  • Accountable for biomarker 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.

 

Apply to this position