Upstream Manufacturing Manager

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

Responsibilities:

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

Qualifications:

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

Working environment:

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

IGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. All qualified applicants will receive consideration for employment.

 
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Research Associate/Senior Research Associate, Cell-line Development

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

Responsibilities:

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

Qualifications:

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

IGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. All qualified applicants will receive consideration for employment.

 
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RA/SRA Downstream

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

Responsibilities:

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

Qualifications:

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

IGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. All qualified applicants will receive consideration for employment.

 
 
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Downstream Scientist/Sr. Scientist

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

Responsibilities

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

Qualifications

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

IGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. All qualified applicants will receive consideration for employment.

 
 
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Downstream Manufacturing Manager

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

Responsibilities:

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

Qualifications:

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

Working environment:

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

IGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. All qualified applicants will receive consideration for employment.

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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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SRA, Upstream Process Sciences (Cell Culture)

We are hiring a Senior Research Associate in our Upstream Process Sciences group to join our rapidly growing team. In this important position, you will support the development of novel antibody products by helping to create upstream processes producing these therapeutic antibodies. You will maintain and expand cells, support the upstream PD lab, and set up and execute antibody production runs at scale up to 200 liters, or larger if needed.

Responsibilities:

  • Maintain and passage CHO expression cell lines.
  • Transfect plasmids into expression cells for transient production.
  • Select and expand expression cell lines for both stable and transient production.
  • Maintain upstream development lab.
  • Determine expression titer by ELISA and other techniques.
  • Document results in laboratory notebooks.
  • Research literature to identify alternative methodologies and solve scientific problems, establish and qualify assays.
  • Prepare technical reports, summaries, and detailed protocols.
  • Share data with management and team members.

Qualifications:

  • BS/BA or higher degree in a biology-related discipline.
  • 3-5 years of experience working with mammalian cell culture and bioreactor/wave systems.
  • Proficiency using Microsoft Office.
  • Aseptic technique.
  • Able to multitask.
  • Able to thrive in a fast-paced, start-up environment.
  • Able to commute to Mountain View.

This job involves working under BSL-2 conditions.

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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