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Senior Manager, Cell Therapy Manufacturing Operations

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Managerial/Professional
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Biologics Development 710928
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135094 Requisition #
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The Senior Manager will be responsible for start-up and leading in-house manufacturing operations for viral vector and cell therapy products for the Biologics Development organization within MD Anderson Cancer Center. This is a leadership position responsible for establishing robust cGMP manufacturing capabilities, onboarding and training manufacturing associates and collaborating with diverse development, technical and quality experts to manufacture innovative therapies in support of Biologics Development strategies and the MDACC mission.



KEY FUNCTIONS


 

· Provide technical, organizational, and manufacturing leadership in all areas within the Cell Therapy Manufacturing facility.  Expertise will include, but not limited to: equipment selection, SOP creation, batch record construction, visual management, status reports, risk assessments, and material selections.

· Provide daily guidance to dynamic manufacturing teams and ensure the members are well trained and knowledgeable of their processes and procedures.

· Ensure transparent communication with staff, teams, support functions, and site leadership team. 

· Develop and implement effective visual management tools within manufacturing areas.  Share best practices in efficient progress tracking systems, dashboards, and management reports, and any other product specific information as needed.

· Establish a culture of continuous improvement, collaborative spirit, and dedication to safe workplace practices.

· Be a visible champion of establishing productive relationships with manufacturing teams and supporting function SMEs.

· Work with a variety of cross-functional teams including process development, quality (QA and QC), facilities, engineering, and supply chain to ensure new processes are scalable and meet cGMP requirements.

· Proactively identify and mitigate short term issues and long term risks.  Implement continuous improvements in manufacturing through technological innovation and alignment with regulatory requirements for clinical and commercial viral vector manufacturing.

· Establish, drive and report key performance indicators in alignment with Cell Therapy Manufacturing and Biologics Development goals.

· Other duties as assigned.


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

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