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AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Associate Director, Cell Therapy CMC

South San Francisco, California Req ID 2205659 Category Research and Development Division AbbVie

Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products — Imbruvica, Venclexta, and Empliciti — and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these three sites. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. This position is based at AbbVie’s new South San Francisco, CA location.

 

Job description:

Key member of the Cell Therapy CMC team who will be working closely with internal and external teams to deliver clinical material for cell therapy trials. Building scope and design of experiments as well as troubleshooting to generate robust GMP bioprocesses and analytics for cell therapy products. Assembling relevant CMC data and authoring regulatory filing documents (CMC sections) and responses to questions from regulatory agencies. Routinely supporting release of GMP batches of cell therapy products. Responsible for drug product management and generating and reviewing technical reports and technology transfer documents. Partnering and aligning with Discovery, Regulatory, Operations, Quality, and Clinical functions, and managing CMC-focused deliverables and timelines to move programs from lab to the clinic and beyond. Routinely presenting updates on CMC progress and apprise CMC Management of plans and risks.

Responsibilities:

  • Understand and develop processes for cell therapy projects.
  • Identify and solve product and production related issues.
  • Support the release of GMP batches of cell therapy products.
  • Facilitate management of timelines, identification of risks and their mitigation.
  • Support the generation and review of technical, regulatory, and other project associated documents.
  • Communicate and actively engage with internal and external teams and collaborators.
  • Participate and present at meetings.

  • Qualifications:

  • Required:
    • A minimum of 8 years of industrial experience in CMC of biologics with at least 4 years in CMC of cell therapies.
    • Excellent writing skills.
    • Degree in biochemical engineering, bioengineering, biotechnology, or other fields relevant to process development and manufacturing of cell therapy products.
    • Good understanding of and hands-on experience with autologous and allogeneic CAR-T manufacturing processes and analytics.
  • Additional desired experience and qualifications:
    • Hands-on experience in process development for generating CAR-T cells and flow analysis.
    • Review of GMP batch records and troubleshooting out of spec and out of trend batch performance.
    • Experience authoring SOPs, regulatory and quality documents.
    • Experience working in GMP facilities of biological products.
Significant Work Activities: N/A
Travel: Yes, 5 % of the Time
Job Type: Experienced
Schedule: Full-time
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