Sr. Manager/Assoc. Director, Manufacturing Quality Assurance

Location
Menlo Park, California, United States
Posted
Apr 20, 2019
Ref
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Required Education
Bachelors Degree
Position Type
Full time
Adicet is developing the next generation immunotherapies by generating a pipeline of allogeneic gamma delta T cell products engineering with CAR or TCR. In addition, Adicet's immune cell platform is complemented by its ability to identify and validate novel disease specific peptide-MHC targets and generates T cell receptor-like antibodies directed against these disease-specific peptide MHC complexes.

Adicet Bio was founded in late 2015 with significant investment from OrbiMed, Novartis Venture Funds and Pontifax. In August 2016, Regeneron and Adicet Bio announced a strategic collaboration to discover and develop next-generation engineered immune-cell therapeutics and in September 2016, Adicet Bio was recognized and named by FierceBiotech as a "Fierce 15" Biotech Company of 2016.

SR MANAGER/ASSOCIATE DIRECTOR, MANUFACTURING QUALITY ASSURANCE

Adicet Bio is seeking an experienced and motivated Senior Manager/Associate Director of Manufacturing Quality Assurance. This position will be responsible for supporting contracted cGMP operations for Adicet's products and supporting internal late-stage preclinical product development. The successful candidate must thrive in a fast-paced team environment, have excellent communication, planning and organizational skills, and be able to independently manage review times to meet Adicet's priorities and communicated timelines.

The candidate must be proficient in the use and maintenance of quality management and document control systems and will be expected to effectively review and follow SOPs and policies, and cGMP compliance regulations. This is a full-time position reporting to the Head of Quality Assurance and is located at our corporate headquarters in Menlo Park, California.

KEY RESPONSIBILITIES
  • Assist in the design, implementation and maintenance of the Adicet Quality System, including document drafting, review, finalization and training
  • Conduct Quality Systems reviews of production documentation, including production batch records, analytical records and any supporting documentation from manufacturing operations at CMOs to ensure compliance with cGMPs and Adicet policies and procedures
  • Prepare material and product disposition documentation
  • Perform routine reviews of all cGMP documentation including batch production records, laboratory notebooks, equipment logs and facility monitoring reports from CMOs
  • Create and/or utilize various databases to track and trend compliance issues and their resolution
  • Assist with investigation and resolution of cGMP or procedural compliance failures including CAPAs, as well as work with staff from other departments to resolve compliance issues found during the Quality Systems review
  • Perform quality oversight of contract cGMP-compliant facilities
  • Assist with training of personnel to ensure compliance and conformance to Company requirements
  • Assist with Quality audits of internal departments, as well as potential and/or current vendors and contract organizations
  • Support Contract Manufacturing Operations as QA Person-In-Plant
  • Support QA Management with various projects as needed
  • Travel
  • Up to 50% travel may be required during certain manufacturing campaigns

QUALIFICATIONS
  • Bachelor's degree or higher in a relevant scientific area is strongly preferred; microbiologist is a plus
  • Minimum 7+ years of Quality Assurance related experience in a cGMP regulated manufacturing environment is required
  • Cell therapy and/or gene therapy experience is preferred
  • Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities
  • Knowledge and ability to sufficiently train others on regulatory compliance issues
  • Strong interpersonal skills and ability to work with others in a positive and collaborative manner
  • Strong verbal and written communication skills are essential
  • Strong communication, prioritization and organizational skills
  • Knowledge of cGMP concepts and guidelines, as well as good documentation practices
  • Ability to utilize multiple word-processing and database applications
  • Experience with an electronic document system is preferred
  • Experience with contract manufacturing operations, especially aseptically-processed biological products