Senior Director or Director of Manufacturing Operations
Facilities | Santa Monica, CA | Full Time
Kite Pharma, Inc. is focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to eradicate cancer cells. We believe our immunotherapy is a market-redefining approach to the treatment of cancer. We are an innovative and growing company located in beautiful Santa Monica and have a highly energized and accomplished team. We had one of the most successful biotechnology IPOs in 2014 and have a current market capitalization of well over $2.5 billion (NASDAQ: KITE).
We are seeking a highly motivated individual to join us as a Senior Director or Director of Manufacturing Operations to support the design, construction, qualification and start-up of our new cellular immunotherapy facility. Initially, the Director will manage the detailed design, selection process for architect, engineering, construction and building trades through full facility and process qualification. Once the facility is operational, the Director will manage the site, including but not limited to hiring and managing staff, maintaining the facility and assume responsibility for the successful commercial manufacturing site.
Responsibilities (include but are not limited to):
- Safety – The top priority is to develop and maintain a safe work environment during construction, qualification and operation. Assure compliance with all local/state and federal safety rules including full OSHA compliance.
- Program Management - Manage all aspects of the project including detailed design, contractor selection and overall program management. Once complete, provide high-level support to all manufacturing programs for the company.
- Contractor Selection and Oversight – Solicit, review and vet bids from contractors and subcontractors. Establish a comprehensive and systematic approach to contractor and vendor management.
- Budget management – Develop and maintain accurate and up to date budgets. Work closely with Kite’s finance department in all budgetary functions. Assure the project is completed at or below budget projections by ensuring the effective use of materials, equipment and personnel. Once the site is operational the Director will need to manage the budget for the facility, staff and materials.
- Permit management – Work closely with our property management firm and assigned legal team to efficiently manage all permits and site inspections. Assure all construction activities are performed in compliance with current city/county and state codes related to environmental, structural, and electrical and work safety requirements.
- Qualification and Validation – Research, select and oversee all qualification and validation contractors at site. Assure work meets all ISPE and GAMP requirements. Perform and manage work in an organized and systematic approach to assure adherence to timelines. Work with internal Quality team once the site is operational to ensure that all quality standards and requirements are implemented and maintained.
- People Management – Carry out management responsibilities including recruit, coach and provide effective feedback to all staff and contractors (in accordance with Kite’s policies, practices and applicable laws).
- Other duties as assigned
- B.S. in Engineering or related field
- A minimum of 15 years relevant experience in pharmaceutical operations including plant construction, qualification and operation of site
- Experience in managing a pharmaceutical manufacturing facility
- Experience in conceptual and detailed design of pharmaceutical commercial production facilities
- Experience in construction management, program management and managing contractors (>$30,000,000 project)
- Familiar with managing local codes and permitting processes at the local and state level
- Experience in commercial plant operations and OSHA regulations
- Proficient in MS Word, Excel, Power Point, Visio, Project, statistical software and other applications as needed
- Ability to work independently with outside companies and contractors, and internal teams to complete complex tasks
- Ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
Kite Pharma, an equal opportunity employer, is located in beautiful Santa Monica, CA just steps from Santa Monica Blvd and right off the 10. We are able to offer the opportunity to be part of the first 100 employees in this successful, fast growing company. A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation. Did we forget to mention the stock options? To learn more about us, please visit our website at www.kitepharma.com.
If you are interested in applying for this opportunity, please submit your resume or CV, cover letter and salary requirements. All submissions will be evaluated and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for one year.
No phone calls please and no agencies or recruiters.