Office Manager

We are looking for a full-time Office Manager to help in the day-to-day operations of our offices in Mountain View.  This key position will report to the VP of HR, and will work closely with all of the departments within our organization.

Responsibilities:

  • Coordinate company events and meetings, as necessary
  • Maintain conference rooms, lunch-rooms, and work areas
  • Assist in new hire onboarding; setting up desks and ordering supplies
  • Support general administrative functions for the office
  • Provide administrative back-up for the Purchasing group
  • Monitor and maintain kitchen and office supplies
  • Assist in the coordination of office operations, procedures, and resources to facilitate effectiveness and efficiency
  • Oversee reception desk and answer phones, as necessary
  • Act as the “face” of IGM to recruits and visitors
  • Assist with projects, as necessary

Qualifications: 

  • 5+ years of experience working in a busy office setting
  • Extremely organized and detail oriented
  • Strong oral and written communication skills
  • Start-up experience is helpful
  • Must enjoy working as part of a team
  • Proficient in the Microsoft Office suite
  • Able to shift gears quickly
  • Able to successfully prioritize with limited direction
  • Able to anticipate and resolve challenges
  • Must be able to commute to Mountain View and work normal business hours

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 Manufacturing

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

Requirements:

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

 Responsibilities:

  • Development of manufacturing plan and establishment of standard operating procedures to ensure high standards of quality, safety, efficiency and schedule compliance.
  • Oversee the internal construction of manufacturing capability, while managing ongoing external manufacturing to meet clinical requirements.
  • Hire, train, develop and evaluate team. Hold direct reports accountable for performance.
  • Partner with Quality and Safety to ensure compliance with quality and safety best practices.
  • Partner with the Clinical Program team to ensure constant supply of released Drug Product.
  • Drive process improvement and metric progress in key areas of responsibility: safety/culture, quality/delivery, cost-effectiveness, efficiency.
  • Head the RFP and diligence process for all external manufacturing contracts.
  • Preparation of CMC documentation for regulatory submissions.
  • Provide design input and key stake holder during construction phase and work in tandem with quality to complete commissioning and validation of the GMP manufacturing facility.
  • Direct responsibility for GMP facility operations.

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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Clinical Development Project Manager

We are looking for a Project Manager to be part of the IGM Biosciences Clinical Research & Development team.  In this key role, you’ll manage projects across a broad range of areas, initially, primarily early clinical development studies in oncology. You will be responsible for delivering the project on time, within budget and meeting the strategic business, strategic and technical requirements, and you’ll consult with management on an ongoing basis to maintain a strategic link to our business needs.

Responsibilities:

  • Responsible for projects and/or program deliverables on behalf of the whole team
  • Drives efficient team meetings with stakeholders including creating agendas, documenting and distributing minutes (including risks and mitigation log, issues and actions log and decisions log)
  • Proactively identify potential program level risks and develop mitigation strategies to address risks
  • Represent the organization as the prime project contact and interact with internal stakeholders and external partners on significant technical matters often requiring coordination between individuals and groups
  • Ensure complex project decisions are made with stakeholder input and discussion and utilizing good single-decision maker model
  • Design and implement new processes by operating as the subject matter expert
  • Communicate appropriate information (complexities, strategies, issues, solutions) within the organization
  • Create partnerships and take responsibility for building effective and high performing teams
  • Guide and influence teams, committees or other forum decision-making bodies and foster a collaborative team environment that excels at leveraging diversity of thinking, innovation and expertise
  • Responsible for the stewardship of multiple projects, programs and respective teams.  Key influencer in decisions, solutions and issues resolution within projects and programs
  • Determine methods and procedures on new assignments and coordinate the activities of others as a team lead. Help define and operate functional solutions to achieve value delivery and business objectives
  • Accountable for managing competing priorities, resources and activities within and across multiple projects and programs
  • Lead, develop, and proactively manage and maintain execution of high quality cross-functional project development plans with detailed timelines and budgets and monitor progress of team in meeting objectives and deliverables.

Qualifications:

  • BA or BS degree and a minimum of 5 to 7 years of leading projects in the pharmaceutical/biotechnology, or healthcare industry
  • Proven track record and complete/full understanding and demonstrated abilities in project management skills and other related disciplines
  • Post-grad coursework is desirable
  • Certified ScrumMaster and PMP Certification is preferable
  • Have successfully led large-scale early clinical development projects (with multiple tracks of work and teams in multiple locations) from concept to delivery
  • Minimum of 3 years of vendor management including strong understanding of business process and operations needed for success and negotiation experience
  • Strong skills in leading teams, problem solving, influencing, teamwork, initiative and communication
  • Demonstrated skills in innovation and creative approaches in building new business process solutions
  • Ability to work flexible hours as needed
  • Experience with T cell engagers, synthetic immunity, cancer immunotherapy and antibody-based therapeutics is preferred

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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IT – Sr. Technical Support Engineer & Administrator

We are seeking an experienced technical support engineer and administrator who can succeed in multiple roles in our expanding early stage biotechnology company of 60 plus. In this dynamic role, you will be the IT point person providing maintenance and support for all facets of the existing computing environment including hardware, software, network, and servers. You will also assist with the evaluation and deployment of business applications and other projects.

The ideal candidate will be a versatile individual who has both a “roll up the sleeves” mentality and excellent customer service skills and can forge ahead independently with minimal direct supervision. A big plus would be someone who also possesses strategic and technical experience in a corporate setting. For the right candidate, this can be a growth position with an opportunity to lead the creation and management of the company’s processes and technology roadmaps. In this role, you will report to the CEO.

Responsibilities:

  • Timely response to and effective technical support for all areas within the corporate computing infrastructure including laptops, lab desktops, applications, mobile devices, and network connectivity.
  • Manage inventory, distribution and setup of computers, software and other IT assets.
  • Manage business systems and applications including telephone/communications systems, internet service, security systems, audio/visual and display equipment, room reservation system, printers, domain accounts, Office 365, and VPN.
  • Assess, provision, install/configure, operate, and deploy third-party applications for integration and implementation into the existing infrastructure, i.e., ERP system.
  • Collaborate with our consulting systems engineer in maintaining Windows server, systems hardware and software, network and related infrastructure.
    Identify network and security vulnerabilities and develop solutions to mitigate the risks and be able to apprise executive management and the board of directors of findings.
  • Maintain and keep current the knowledge base, process and inventory documentation.

Qualifications:

  • Bachelor’s degree or equivalent experience.
  • 5+ years of relevant IT experience, preferably some in biotech.
  • Positive, can-do attitude with strong interpersonal and communication skills to work with all levels in the company from entry level personnel to board of directors.
  • Approachable and responsive user support attitude.
  • Strong technical skills and adept at problem solving, diagnosis and troubleshooting.
  • Self-starter with capability to complete tasks & projects with minimal direct supervision.
  • Ability to work under pressure and multi-task in a fast-paced environment.
  • Experience in selection, implementation and ongoing administration of an ERP system, preferably in a manufacturing-intensive biotech company, is helpful.
  • Working knowledge of collaboration and communications platforms, i.e., Box, Office 365.
  • Advanced knowledge of a range of computer systems, software, applications, hardware, and PC and Mac operating systems.
  • Knowledge of Windows network computing and networking fundamentals.
  • Knowledge of applicable regulatory requirements, data privacy practices and laws as they relate to the management of IT Infrastructure in GMP environments is helpful.
  • Public company experience is helpful.
  • Must be able to commute daily to Mountain View and work on-site. Must be available for emergency assistance off-site on nights and weekends.

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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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/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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