Biologics Quality Control Senior Manager

Education

Required: Bachelor's degree in a related field.  

Preferred:Bachelor's Degree in Analytical Chemistry, Life Science, Microbiology, Biochemistry, or related discipline. 

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:

• 10+ years in a pharmaceutical quality control role with a minimum of 5 years in a management role.

• Strong knowledge of pharmaceutical microbiology and contamination control, aseptic processing and supporting technologies.

• Demonstrated experience in cleanroom facility and microbial test methods validation. 

• Direct experience with analytical method development, validation and transfer as well as product characterization and analytical comparability.

• Experience with qPCR, ELISA, and cell-based assays and running multicolor flow cytometry with working knowledge of BD flow cytometers.

• Excellent judgment and creative problem-solving skills, including the ability to devise and implement practical solutions to resolve complex issue. 

• Excellent interpersonal, organizational, written and oral communication skills.

• Previous experience working with non-conformances, and corrective action and preventive action processes.

• Demonstrated ability to manage a number of projects simultaneously. 

• Ability to effectively plan and organize work activities and prioritize task completion to adhere to schedules and deadlines.

• Extensive knowledge of cGMP, ICH and FDA and USP compliance.

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