Associate Director, Cell Therapy Manufacturing Facility Operations

The mission of The University of Texas MD Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research, prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public.

The Associate Director of Cell Therapy Facility (CTMF) Operations, will be responsible for oversight and operations of the CTMF site including all cGMP cleanrooms, laboratories, support areas, general use office spaces. The Associate Director will lead efforts toward engineering, commissioning, qualification, validation and maintenance of CTMF facility assets in support of the CTMF master plan and Biologics Development strategies. The role will require supervision and selection of contractors, architects, subcontractors and other trades required to effectively carry out responsibilities. This role serves as the CTMF primary liaison with MD Anderson Facilities Management to ensure efficient use of MDA capabilities, application of best practices, and ensure compliance with cGMPs and MDACC institution policies. This role reports to the Head, Cell Therapy Manufacturing and is a contributing member of the CTMF Site Leadership Team.

KEY FUNCTIONS

•Partner with stakeholders to define material and personnel flows, cleaning procedures, gowning requirements and other procedures necessary to ensure cGMP compliant operations of cleanrooms and supporting areas

•Collaborate with CTMF cross-functional leaders to identify and prioritize Biologics Development requirements for manufacturing, laboratories and office spaces

•Develop a comprehensive GMP Facility Master Plan that is aligned with the vision and goals of the Biologics Development Department

•Collaborate with MD Anderson Facilities Management to develop and maintain all Engineering Standards for CTMF. Oversee all certification, calibration, functional verification and maintenance of cGMP facility assets.

•Manage CTMF site engineering drawings, facility modifications, and relevant change controls.

•Draft necessary cGMP documentation when events require, such as deviations, change controls, and SOPs. Take ownership of implementing effective CAPAs and support deviation investigations.

•Develop and implement cGMP and industry compliant standards for preventative maintenance and expected life of selected CTMF assets. Oversee execution of preventive maintenance schedules and procedures for the CTMF site.

•Provide Energy Management Protocols for efficient management of consumable resources in the facilities for electricity, chilled water, hot water, natural gas and domestic water

•Oversee Access Control Systems for the site

•Work with vendors, contractors and professional service providers to ensure proper contracted work and services necessary to proper and optimum facility operations

•Support CTMF audits and regulatory agencies inspections from regulatory agencies relative to utilities, worker safety, waste removal, validation and commissioning of operations

•Ensure appropriate Business Continuity Planning, Emergency Coordination and Risk Management procedures are implemented within the site

•Hire and manage CTMF cGMP cleaning staff. Ensure SOPs meet standards for cGMP and are effective in maintaining such standards for particulate and microbial contaminants for cGMP cleanrooms and supporting spaces.

•Schedule, oversee and communicate facility related repairs in emergency events

•Visible champion for safety and awareness on and off the site. Liase with MD Anderson EHS to establish initiatives and practices for CTMF to ensure compliance with federal, state and local environmental, fire, health and safety regulations.

•Establish productive and respectful relationships with production teams, development SMEs, and MDA supporting departments

Education

Required: Bachelor's degree in a related field.

Experience

Required: Eleven years of relevant experience to include six years of managerial experience. With Master's degree, nine years of relevant experience to include six years of managerial experience. May substitute required education degree with additional years of equivalent experience on a one to one basis.

Preferred:

- Minimum of 11 years of facilities, design, construction, qualification and/or validation of cleanroom and manufacturing facilities. Minimum of six years leading people.

- Eight years or equivalent in HVAC, electrical, plumbing systems, deep general knowledge of facilities, construction, general contracting and permitting requirements

- Experience Building Automation System and Access Control Systems

- Experience managing construction of cleanroom facilities and other specialized facilities and equipment required for GMP compliant manufacturing of regulated medical products, etc.

- Demonstrated knowledge of clinical and/or commercial biopharmaceutical manufacturing

- Working knowledge of the current Code of the Federal Regulations (CFR's) and current Good Manufacturing Practices (cGMP's)

- Experience in interfacing with inspectors from regulatory authorities (FDA, EMA, MHRA, etc.)

- Experience in facility and or process area start-up activities

- Self-motivated and willing to accept temporary responsibilities outside of initial job description

- Influential leader with excellent interpersonal, verbal and written communication skills

- Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities

- Willingness to think outside of the box, ability to adapt in a constantly evolving environment

- Able to work off shift hours and weekends, as well as provide the on-call support as required

It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html

Additional Information
  • Requisition ID: 135943
  • Employment Status: Full-Time
  • Employee Status: Regular
  • FLSA: exempt and not eligible for overtime pay
  • Work Week: Days
  • Fund Type: Soft
  • Pivotal Position: Yes
  • Minimum Salary: US Dollar (USD) 148,500
  • Midpoint Salary: US Dollar (USD) 185,750
  • Maximum Salary : US Dollar (USD) 223,000
  • Science Jobs: Yes