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    Manager, Quality Control, Raw Materials - San Diego, United States - Artiva Biotherapeutics

    Artiva Biotherapeutics
    Artiva Biotherapeutics San Diego, United States

    6 days ago

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    Description

    Job Description

    Job DescriptionSalary: Base Salary: $113,000 - $147,000. Exact compensation may vary based on skills and experience.

    About Artiva:

    Artiva Biotherapeutics is an immunotherapy company with the ability to produce off-the-shelf, allogeneic NK cell therapies at a massive scale. Our mission is to develop effective, safe and accessible cell therapies for patients with devastating autoimmune diseases and cancers. Our lead program, AlloNK, is an allogeneic, non-genetically modified NK cell therapy candidate designed to enhance the activity of monoclonal antibodies or NK cell engagers. AlloNK is currently in clinical trials in combination with rituximab for treatment of systemic lupus erythematosus (SLE) in patients with active lupus nephritis and for treatment of Non-Hodgkin Lymphoma, as well as in combination with Affimed's innate cell engager AFM13 for the treatment of patients with relapsed/refractory CD30-positive lymphomas.

    Job Summary:

    Artiva Biotherapeutics is seeking a skilled and motived Quality Control Manager for Raw Materials (RM) who will be reporting to the Director of Quality Control. This person will be responsible for developing, leading, and managing the QC Raw Materials testing program at Artiva. This role will develop and maintain all documentation with regards to testing requirements and strategies, serve as a subject matter expert (SME) for raw materials issues, providing technical expertise aligned with current GMPs and current industry practices. This person will have knowledge and experience with USP methods, and the ability to apply as required, and as well as maintaining compliance to USP, ICH and FDA guidance documents. Interface with Manufacturing, Materials Management, Facilities and Quality Assurance leadership and participate/lead in interdepartmental teams to address quality-related issues.

    Duties/Responsibilities:

    • Manage and oversee Artiva's cGMP Raw Materials program.
    • Develop and maintain all documentation with regards to testing requirements and strategies
    • Serve as a SME for raw materials issues, providing technical expertise aligned with current GMPs and current industry best practices.
    • Manage and work with contract laboratories for testing raw materials.
    • Assess compendial changes; lead change for revision of existing assays and identifies need for development of new assays with compendial and GxP requirements as needed.
    • Accountable for managing the raw materials testing program to ensure quality, product specifications and adherence to all current GMPs, USP, ICH and FDA guidance documents.
    • Evaluate QC systems and recommend and/or implement system improvements.
    • Author technical protocols and reports for Raw Materials testing qualification, validation, or verification.
    • Review and approve technical and validation/verification protocols and reports.
    • Write test methods and SOPs for the Raw Materials testing program.
    • Create, review, and approve out-of-specification (OOS) and out-of-trend (OOT) investigations, deviations, CAPAs, and Change Controls.
    • Provide necessary training and mentoring to direct reports and create opportunities for staff development.
    • Maintain records and databases in accordance with procedures.
    • Hire and manage staff as needed.
    • Oversee management of in-house raw material test equipment.

    Qualifications:

    • Bachelor's or advanced degree in biology, biochemistry or closely related scientific discipline.
    • At least 7-10 years of CGMP QC experience in a cell therapy/biotech/pharmaceutical setting is required.
    • Expert knowledge of pharmaceutical / biotech Raw Materials testing is required.
    • At least 3 years of management experience is required.
    • Basic knowledge of qualifications and validations; current industry practices; and strong experience with guidance interpretation and application.
    • Knowledge of cGMPs, ICH, USP, FDA requirements is required, including equipment and method validation/verification.
    • Experience with risk assessment tools is desired (FMEA, Fish Bone, 6Ms, etc.)
    • Excellent critical thinking and technical writing skills.
    • Excellent interpersonal and communication skills to lead, facilitate and follow.
    • Computer skills required to operate Microsoft Word, Project, Visio, and Excel programs.

    Why you should apply:

    We have a fantastic team and philosophy We are passionate – we deeply care about our team, our science, and improving the lives of cancer patients. We are tenacious – laser-focused on our mission and undeterred in our commitment to deliver life-saving medicines for cancer patients. We are innovative - pushing into new frontiers for patient benefit. We are transparent - believers in flat, accessible, and open communication paths. We are inclusive – committed to the diversity of our team and ensuring that all voices are heard.

    In addition to a great culture, we offer:

    · A beautiful new facility

    · An entrepreneurial, highly collaborative, and innovative environment

    · Comprehensive benefits, including:

    • Medical, Dental, and Vision
    • Group Life Insurance
    • Long Term Disability (LTD)
    • 401(k) Retirement Plan
    • Employee Assistance Program (EAP)
    • Flexible Spending Account (FSA)
    • Paid Time Off (PTO)
    • Company paid holidays, including the year-end holiday week
    • Our recognition program, , is where you can trade in points earned for things you want.

    If all this speaks to you, come join us on our journey

    Artiva Biotherapeutics is an equal employment opportunity employer.

    Base Salary: $113,000 - $147,000. Exact compensation may vary based on skills and experience.

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