Biologics QC Associate Director

Location
Houston, Texas
Salary
Competitive
Posted
August 17 2021
Ref
142671
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 ASSOCIATE DIRECTOR

The QC Associate Director will lead the QC functions and collaborate cross functionally to drive and implement Biologics Developments' Quality methods, processes and operations for new or existing products and/or technologies to ensure high quality clinical drug product manufacturing testing. This position is responsible for all work completed within the QC group: QC systems, Analytical Chemistry, Microbiology (including Environmental Monitoring and Sterility Assurance), Method Validation and, Stability. The role will lead continuous improvement activities of all quality control systems and drive a continued state of inspection readiness. The Associate Director will report to the Head of Quality and Regulatory Submissions and be a contributing member of the site leadership team.

RESPONSIBILITIES

• Directs the development, validation, planning, implementation, and maintenance of QC test methods, processes and operations.
• Provide guidance for the design and execution of the environmental monitoring program and sterility assurance program for GMP manufacturing operations.
• Develops QC capabilities for raw material and product testing.
• Provide oversight for method qualification and validation from Analytical Development and/or clients.
• Oversee raw material, in-process and final release testing.
• Responsible for ensuring the appropriate stability programs are initiated and completed to support product development.
• Ensures quality control systems and equipment are compliant to Biologics procedures and applicable regulatory guidelines
• Oversee Quality Control requirements for compliance with cGMP/CFR/ICH/ regulations and guidelines and ISO/USP standards at external contract manufacturing and testing organizations
• Provide guidance and actively participate in non-conforming events -OOT, OOS, Deviation & CAPA - Assure effective root cause investigations and implementing corrective actions.
• Serves as primary QC contact for regulatory inspections and client audits.
• Drive continuous improvement projects in collaboration with internal and external stakeholders.
• Lead and support GMP readiness activities for new programs.
• Represent quality control at various project and technical meetings, as needed.
• Lead and participate in projects within the organizations objectives and project timelines and participate in cross-functional projects as the quality control subject matter expert.
• Collaborate with other leaders across the organization and assist in the continuous improvement.
• Prepare and present periodic management updates on Department activities to Leadership.
• Hires, manages and trains staff. Plans and assigns duties to meet departmental and organizational objectives. Provides guidance and direction to staff; including appropriate training and mentoring and development of staff.
• Build collaborative relationships with cross functional areas to facilitate manufacturing operations
• Other duties as assigned.

Education

Required: Bachelor's degree in a related field.

Experience

Required: Eleven years of relevant experience to include six years of managerial experience. With Master's degree, nine years of relevant experience to include six years of managerial experience

Preferred:

• Minimum of 11 years in a QC role in the biopharmaceutical industry. Minimum of six years leading QC team.
• Knowledge of GMP, FDA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products.
• Strong knowledge of current industry trends and the ability to use the latest technologies.
• Working knowledge of aseptic practices, clean room design/operations, sterility assurance, and auditing techniques.
• Strong leadership skills with the ability to thrive in a high throughput environment
• In-depth understanding and application of GMP principles, concepts, practices and standards in the US.
• Demonstrated success establishing and managing QC operations in a cGMP environment
• Demonstrated experience building and leading exceptional Sterility Assurance programs
• Strong knowledge of biological or cell culture-based manufacturing processes.
• Experience in interacting with health authorities including direct involvement with agency inspections.
• Direct experience in participating in client and regulatory agency audits.
• Direct experience in facility validations and process area start-up activities.
• 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

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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