Senior Manager, Cell Therapy Manufacturing 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. 

Preferred:

· Experience in a variety of viral vector and cell therapy cGMP manufacturing processes. 

· Proficient in technical transfer of manufacturing processes and process scale-up.

· Excellent aseptic/sterile techniques.

· Demonstrated knowledge of clinical and 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.

· Ability to think critically, and demonstrated troubleshooting and problem solving skills as applicable to manufacturing process and equipment.

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

· Excellent interpersonal, verbal and written communication skills are essential in this collaborative environment.

· 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.

· Yellow or Green Belt training in lean manufacturing a plus.

· Ability to lift 40 lbs repeatedly and stand for hours at time.

· 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