Senior Director, GMP Biopharma Facilities Operations

Compensation

: $88,810.00 - $169,280.00 /year *

Employment Type

: Full-Time

Industry

: Scientific Research



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SUMMARY

  • Seeking seasoned GMP facilities operations management leader with biotech industry or pharmaceutical industry facilities operations expertise and technical foundation in engineering.
  • This is a chance to break into the cell therapy sector of facilities operations: Cell therapy experience, though a plus, is not a mandatory requirement. Our essential need is for expertise in GMP lab-and-office space expansion and operational-management skills.
  • This is for a rapidly growing cell-therapy focused biotech startup with a staff of exceptionally skilled, motivative, and collaborative teams; people who are willing to wear many hats, work hard, but do so in a collegial and support work environment.
  • The facilities management role will provide, engineering know-how, operational and technical Coordination and guidance, and advanced decision-making skills; will do so to optimize facilities expansion increase much needed lab capacity, office capacity, and manufacturing capabilities.
  • Will be a key contributing leader and team member of a cutting-edge startup that develops cell therapies to meet unmet clinical needs by tackling challenging diseases--always with the patients in mind.
  • The company values its people; and has demonstrated this by successfully creating an open and highly supportive work environment, one that would be particularly attractive to a facilities leader who thrives in a collaborative work culture. In addition to the company's pioneering technology and supportive work culture, the company offers competitive compensation, good benefits, and stock participation.

ROLE OVERVIEW & REQUIREMENTS

  • BS or MS with several years experience in GMP facilities expansion and operational management of office space, GMP lab facilities, utility systems (water, air, HVAC, etc.), IT systems, and equipment management. Experience with a biotech/pharma startup would be desirable (with cell therapy a plus but not essential.).
  • A strong engineering foundation is essential as is experience in validation of new facility GMP production-suites; experience in documentation requirements tied to commissioning and validation of Facilities/HVAC/utilities systems.
  • GMP facilities oversight experience and expertise that includes a foundational technical understanding of GMP-compliant facility needs and requirements, and decision-making skills, and strong coordination, collaboration, and communication skills to work effectively with contractors and support internal customers.
  • Expertise in FDA cGMP regulations and requirements for manufacturing-facility utilities that includes understanding of cGMP compliance within controlled space.
  • Expertise overseeing metrology and calibration of GMP facilities equipment and instrumentation.
  • Strong mechanical aptitude and troubleshooting skills; ability to read and interpret engineering documents; working knowledge of computerized maintenance management systems.
  • Proven organization, coordination, communication and multi-tasking strengths to handle a fast-pace and collaborate effectively with vendors, contractors, and diverse scientific and engineering discipline to maintain a high level of customer service.
  • Requires current residency in San Francisco Bay Area and established US work authorization.

HOW TO APPLY

  • Use the BioSpace 'apply' link or email your resume directly to ...@biotecher.com using the following code on your subject line: SrDrFac-GMP

Associated topics: bacteria, biopharmaceutical, dietary, drug discovery, health, industrial hygienist, kinesiology, medical, medicine, therapeutic * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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