Head of Manufacturing

Precision BioSciences, Inc Located in: Durham,  North Carolina
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Precision BioSciences, Inc Biotechnology Jobs Pharmaceutical Careers
 

JOB DESCRIPTION

Precision BioSciences is a next-generation gene editing company working to create new genetic medicines and agricultural products that address world food supply challenges. We are currently looking for the Head of Manufacturing.

The Head of Manufacturing will be a key member of our Central Resources team, driving operational excellence in the manufacturing of investigational drug substance and drug products for worldwide distribution. The Head of Manufacturing will work closely with other functions of the company, including Facilities and IT, Regulatory Affairs, Quality Assurance, Clinical, Technical Operations, Process Development, and Analytical Development. This leader will spearhead the management, recruitment and build-out of the Manufacturing team as the CAR-T and TCR cell therapy and gene therapy product pipeline advances and grows at Precision Biosciences.

Essential Duties and Responsibilities

  • Develop the operational strategy and core processes and documentation for flawless manufacturing execution in a 2,300 sq. ft cGMP cleanroom with Grade B, C, and D spaces.
  • Manage all cGMP-related qualification, manufacturing, and testing activities at Precision Biosciences.
  • Establish strong relationships with critical manufacturing support systems vendors and testing partners. 
  • Apply technical and management expertise to meet project goals and timelines, including participating in technology transfers between Precision Biosciences and its development partners.
  • Ensure the execution of sound manufacturing processes for CAR-T and TCR cell therapy drug substance and drug product, AAV drug substance, and mRNA drug substance that meets global regulatory expectations. 
  • Prepare short- and long-term budgets, working with key departments and the leadership team.
  • Assist in the conceptualization and execution of the Precision Biosciences’ long-term manufacturing platform strategy including COGs reduction and process intensification
  • Manages the schedules of all FAT/SAT, IQ/OQ/PQ, manufacturing and QC testing activities and related data processing activities for all Precision Biosciences’ cell and gene therapy products
  • Trains manufacturing personnel and ensures compliance with all cGMP guidelines
  •  Performs other related duties as assigned

               

CRITICAL REQUIREMENTS

  • Qualifications  Education/Experience:
    • BS, MS or Ph.D. in Immunology, Cell, or Molecular Biology; Chemistry; Mechanical, Chemical or Bioengineering with 8+ years of biopharma manufacturing, process development, analytical, or CMC/IMPD experience, or equivalent
    • Proven experience in the incorporation of novel technologies as applied to biomanufacturing
    • Preference given to candidates with Lean Manufacturing experience (Poka Yoke, 5S, Kanban, etc.)
    • Preference given to candidates with cell therapy, RNA, or viral vector manufacturing experience, or relevant protein biologics experience.
    • Excellent understanding of Quality Assurance and Quality Management Systems to ensure adherence to cGMP and GLP requirement and SOP’s. 
    • Good conceptual, strategic, analytical, problem solving, and organizational skills. 
    • Ability to explore creative approaches to accelerate the CMC/IMPD execution while complying with the regulatory approval of the drug products. 
    • Excellent communication skills, both verbal and written, and the ability to interface effectively with engineering, regulatory, sales, marketing, and administration.  Additionally, strong communication skills with outside vendor organizations is required. 
    • Outstanding leadership and management capabilities to build, motivate and manage a strong organization. Personal alignment with Precision’s values, mission and vision. 
    • Should have a sound knowledge of Microsoft Office software suite, Regulatory Asset Management and Document Management software, EMS software and systems, enterprise software such as SAP, and project management software.
     

COMPANY INFORMATION

At Precision, leaders in genome editing utilize the ARCUSĀ® editing platform to eliminate cancers, cure genetic diseases, and create safer, more productive food sources.

JOB INFORMATION

Seniority Level:
C-level / Executive Officer
Function:
  Clinical Research / Affairs,  Manufacturing,  Laboratory
Preferred Industry Background:
  Biotechnology,  Laboratory / Diagnostic Services,  Research
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation:
Education Required:
Any
Therapeutic Experience:
Immunology