Director of Operations - GMP

  • Location

    South San Francisco, California

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Hanaa Sammra

  • Contact email:

    Hanaa.Samrra@voltinternational.co.uk

  • Job ref:

    BBBH1297_1627045646

  • Published:

    3 months ago

  • Expiry date:

    2021-08-24

Director of Operations, GMP Facilities
San Francisco

We are recruiting for a highly motivated and driven Director of Operations to work within Cell Therapy Biotech who have a unique manufacturing platform who are passionate about providing affordable and life changing cell therapies to patients. You will be overseeing GMP clean rooms suites, laboratories, offices and GMP systems. You will be responsible for managing and maintaining the entire facility. Demonstrate leadership skills to manage day to day facility operations while collaborating with other functional heads who are committed to developing the best solutions possible.
Responsibilities

*Production operations are all controlled and executed according to the GMP regulatory guidelines and monitoring GMP equipment
*Acts as a liaison with regulatory agencies (e. g., FDA, EMA, EPA, OSHA) and community officials relative to GMP utilities, permitting, licensing, validation and commissioning of operations
*Ensuring leadership is provided to departments such as QA, QC, process development manufacturing and MSAT operations
*Overseeing the manufacturing of biopharmaceutical for pre-clinical, clinical, commercial use under GMP/GDP FDA Regulations
*Maintaining the daily operations of the manufacturing staff
*Developing and Implementing GMP processes and SOPs for GMP staff to follow
*Manage third party providers and external consultants
Requirements
*Bachelor's degree or a Masters in a Life Sciences field
*Previous experience with setting up with setting up new equipment and processes for a GMP facility
*At least 7+ years working directly within GMP regulated facility in the pharmaceutical or medical area with an understanding of GMP quality systems
*At least 3 years' experience in cell therapy