Biologics Quality Control Senior Manager

Location
Houston, Texas
Salary
Competitive
Posted
September 14 2020
Ref
135726
Discipline
Health Sciences
Organization Type
Healthcare/Hospital
The mission of The University of Texas M. D. Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public

Therapeutics Discovery and Development

MD Anderson Cancer Center (MDACC), the largest research-based Cancer Center in the nation, is taking a unique approach in the battle against cancer. It is well-known that MDACC is home to an esteemed academic faculty that cover all aspects of cancer research, publish prolifically in leading journals and present extensively at all major conferences. In addition MD Anderson boasts a vast oncology clinic that runs more clinical trials than any other institution and has created unparalleled capabilities is cell therapy trials. In between the basic science and the translation, MDACC has created a powerful engine driving the future of new targeted, immune- and cell-based therapies: The Therapeutics Discovery and Development (TDD) Division. TDD eliminates the bottlenecks that hamper traditional drug discovery, with a multidisciplinary team of dedicated researchers, doctors, drug developers and scientific experts working together to develop small-molecule drugs, biologics and cellular therapies. Our unique structure and collaborative approach allows the team to work with agility, bringing novel medicines from concept to clinic quickly and efficiently - all under the same roof.

Biologics Product Development

Biologics, be it monoclonal antibodies (mAbs) or cell therapies are complex therapeutics that are revolutionizing the treatment of cancer and yet are difficult to robustly develop and manufacture. To unlock the potential of these modalities MDACC is investing in Biologics Development capabilities within TDD accelerate the results we have already achieved, with multiple programs currently in clinical development. The goal will be to develop industrial biologics with a commercial horizon within the innovative environment of an academic cancer center. The group will be a composite of industry veterans who are interested in applying their experience to develop innovative therapeutics and see them impact patients, as well as academics looking to turn science into products. We work in a fast-paced, milestone-driven environment with a focus on team science and interdisciplinary research. Our unique approach has created a biotech-like engine within the walls of the nation's leading cancer center to bring life-saving medicines to our patients more quickly and effectively.

BIOLOGICS QUALITY CONTROL SENIOR MANAGER

The Quality Control Senior Manager is responsible for developing and maintaining a Quality Control organization with a rigorous quality mindset ensuring strict adherence to Biologics' compliance practices. This position will oversee QC activities for cell therapy and viral vector GMP manufacturing including raw material testing, final product testing, stability testing, method qualification/validation and the sterility assurance and contamination control program.

This individual will work closely with Analytical Development and Manufacturing groups and provide operational leadership to the Quality Control team ensuring the execution of responsibilities within the Quality System.

RESPONSIBILITIES

•Develop, manage and oversee Quality Control functions including areas of raw materials testing, in-process and final product testing, microbiology and stability.

•Plans and reviews operations for assigned staff, including responsibility for training, managing and evaluating as well as coordinating, scheduling and assigning work and maintaining standards.

•Ensures production support to manufacturing and supply chain for timely release of products.

•Oversee GMP stability planning, execution, data analysis and data trending in support of product expiry/shelf life determination.

•Oversee QC elements of raw materials qualification program.

•Establish and manage processes for method qualification and validation and, tech transfer activities to ensure product quality to meet regulatory requirements.

•Responsible for the sterility assurance and contamination control program including development of the QC microbiology laboratory, GMP facility qualification, aseptic process simulation, disinfection procedures / practices, disinfectants qualification, cleaning validation, environmental monitoring program and microbiological testing of final product.

•Responsible for the retain sample management program.

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

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