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Senior Manager, Cell Therapy Manufacturing Facility Operations
Education
Required: Bachelor's degree in a related field.
Experience
Required: Eight years of relevant experience to include four years of managerial experience. With Master's degree, five years of required experience to include four years of lead or supervisory experience. May substitute required education degree with additional years of equivalent experience on a one to one basis
Preferred:
- Minimum of 10 years of facilities, design, construction, qualification and/or validation of cleanroom and manufacturing facilities. Minimum of five 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