Associate Director, Validation

Employer
Kite Pharma
Location
Frederick, MD, United States
Posted
Jul 02, 2019
Ref
R0008304
Required Education
Bachelors Degree
Position Type
Full time
Kite, a Gilead Company, is a biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient's own immune system to selectively target and kill cancer cells. Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies. We are on a rapid growth trajectory and we have a highly energized and accomplished team.

Everyone at Kite is grounded by one common goal - curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Would you like to join us in this mission?

We are seeking an Associate Director, Validation, to support our new commercial biotechnology facility in Frederick, Maryland which includes all units required for clinical and commercial bio-processing. In this role, you will be responsible for running and leading all validation efforts, including the development and maintenance of the site Validation Master Plan. You will have direct reports and you will provide quality and technical direction to multi-functional teams while actively participating in driving and developing strategies for continuous improvement of the engineering/facilities/validation quality systems.

Responsibilities include all respects of the validation process, including developing and performing qualification studies to document evidence to ensure that equipment and processes will satisfactorily meet the client and facility specifications for quality. You will perform the qualification and validation of equipment, facilities, utilities and systems. You will assist in equipment selection, specification, and the application of a risk-based approach when figuring out qualification strategies. You will work on complex problems in which analysis of situation or data requires an evaluation of intangible variables. You will exercise independent discernment in developing methods, techniques and evaluation criteria for obtaining results.

Key Job Responsibilities (what you will be doing):
  • You will ensure a robust quality system is in place for the facility, to include: equipment & lab instruments; utilities, engineering, maintenance, computerized systems and validation activities.
  • You will ensure validation protocols and processes comply with global regulatory requirements.
  • Correctly employ industry methodologies that will successfully withstand regulatory inspections by regulatory authorities.
  • Provide Validation oversight of change control for manufacturing systems, including facility and equipment projects.
  • Provide Validation oversight of equipment, facility and utility qualification, computer system validation, cleaning validation, and shipping validation.
  • Compose process validation, cleaning validation and process optimization protocols.
  • Clearly and accurately document activities.
  • Identify specific parameters, sampling and tests used in the validation protocols of new and existing products.
  • Serves as information resource for validation technicians, contractors and vendors.
  • Provide recommendations to batch records.
  • Monitor manufacturing processes during production to assess any technical process issues.
  • Lead investigations and complete CAPA assignments.
  • Performs other duties as assigned.


Essential Job Requirements:
  • Minimum requirements include a Bachelor's degree in a technical, preferably an engineering or biological science discipline and 10+ years pharmaceutical and/or biopharmaceutical industry experience or MS degree in a technical, preferably an engineering or biological science discipline with 8 years' experience in a pharmaceutical and/or biopharmaceutical industry experience.
  • Do you have an advanced degree or additional industry certification? If so, please include it.
  • Experience validating equipment & lab instruments; utilities, engineering, maintenance, computerized systems and validation activities in a GMP environment.
  • Experience leading a team


Does this sound like you? If so, we encourage you to apply.

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IND123

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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