Director of Quality Control

Location
California, United States
Posted
Wednesday, 21 October 2020
End of advertisement period
Monday, 21 December 2020
Ref
87063
Contract Type
Permanent
Hours
Full Time

Grade: M
FTE: 100%

The Laboratory for Cell & Gene Medicine (LCGM) at Stanford University is seeking an Director of Quality Control (RTM2) to ensure compliance of the LCGM with all Federal and State regulations governing the manufacturing of cell and gene therapy products for Phase I/II clinical trials conducted under Investigational New Drug (IND) applications. The Director will oversee the quality control activities related to process development, manufacturing and release testing of products and novel analytical development and assay testing; will ensure facilities and manufacturing operations are conducted according to current Good Manufacturing Practices (cGMP); will provide training and certification for manufacturing and quality control staff; will control distribution, tracking and archiving of clinical materials and provide validation support for all equipment and processes essential to the production of biotechnical products. The Director will be part of the LCGM management team and will act as a liaison between LCGM and clinical and research investigators, other collaborators and vendors.

The Laboratory for Cell and Gene Medicine (LCGM) is a multi-product biologics manufacturing facility that provides regulatory, quality systems, process development and manufacturing support to the School of Medicine, Lucile Packard Children’s Hospital (LPCH) and Stanford Health Care (SHC) in developing innovative cell and gene-based therapies for the treatment of disease and the promotion of health in pediatric and adult patients in Phase I/II clinical trials.

Learn more about our team here: https://med.stanford.edu/lcgm.html.

Duties include:

  • Provide strategy and vision; make decisions that establish objectives for the overall direction or operation of a significant project(s) or area(s).
  • Manage staff of a large science, engineering, and/or technical research area, which includes recruiting, hiring, developing, evaluating and setting priorities; manage business, technical, and educational activities for direct reports including managers and technical experts.
  • Identify, clarify, and resolve issues with strategic impact and substantial significance, which spam multiple areas, using advanced technical and professional knowledge requiring broad discretion and judgment.
  • Collaborate with others on the direction of activities relevant to long-term objectives. Develop strategies to ensure effective achievement of objectives.
  • Develop policies and procedures as they relate to academic or program activities.
  • Implement, evaluate and maintain quality control standards to ensure program success.
  • Establish, oversee and manage financials and schedule for large programs and/or multiple projects.
  • Recommend the adoption of emerging technologies and the development of new methods and approaches.
  • Negotiate with internal departments and external agencies with authority to commit resources and effort.
  • Serve as a liaison to senior management, cross-functional areas, schools and external organizations such as sponsors and government agencies.

* - Other duties may also be assigned

DESIRED QUALIFICATIONS:

  • PhD and 8+ years of industry (or equivalent) experience in a biologics cGMP compliant work environment.
  • Record of publication of scientific findings in peer reviewed journals
  • Experience in Immunology, Oncology, Cell and Gene Therapy desirable; experience in Analytical Development

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor's degree and eight years of relevant experience or combination of education and relevant experience. Advanced degree may be required.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

  • Experience leading, managing, motivating and developing technical staff.
  • Experience leading complex scientific, engineering or technical research projects or programs.
  • Detailed understanding of relevant business and technical knowledge and problem resolution.
  • Ability to synthesize and articulate technical and scientific methodologies, specifications, and information.
  • Knowledge of emerging technologies, trends, methodologies, and resource management principles.
  • Demonstrated ability to work and communicate effectively with others.
  • Exceptional customer relationship and consensus building skills.
  • Ability to influence and establish effective working relationships in a diverse environment.
  • Ability to resolve complex issues quickly and make decisions that meet university objectives in a collaborative culture.

PHYSICAL REQUIREMENTS*:

  • Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push pull objects that weigh to ten pounds.
  • Occasionally sit, use a telephone or write by hand.
  • Rarely kneel, crawl, climb, twist, bend, stoop, squat, reach or work above shoulders, sort, file paperwork or parts, operate foot and hand controls.

* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

Additional PHYSICAL REQUIREMENTS: (remove if none)
WORKING CONDITIONS:

May require extended hours, evenings and weekends.

Additional Information

  • Schedule: Full-time
  • Job Code: 4987
  • Employee Status: Regular
  • Grade: M
  • Department URL: http://pediatrics.stanford.edu/
  • Requisition ID: 87063

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