Biologics QC Specialist III

Location
Houston, Texas
Salary
Competitive
Posted
March 10 2021
Ref
137094
Organization Type
Healthcare/Hospital
The mission of The University of Texas MD 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 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.

The Biologics QC Specialist III is responsible for assisting in planning, developing and maintaining the validated biological assay program and for performing complex Quality Control assays to support manufacture and release of cell therapy and viral vector products.
The role holder will provide validation support to the analytical QC Department so that authorized techniques, methods and procedures are validated as required. In addition, the role holder will provide technical support within the QC Laboratory, and will function as a project manager, maintaining department timetables.

KEY FUNCTIONS

• Perform analytical testing on cell and viral therapy products, to verify product quality, sterility, and safety following standard operating procedures (SOPs).
• Accurately perform, analyze and demonstrate proficiency of the following tests;
- Automated and manual cell counts and viability
- Flow cytometry analysis
- ELISA
- Molecular PCR assays.
• High level of aptitude for analytical equipment and software such as Kaluza, SDS, and Softmax, as well as 21CFR Part 11 requirements.
• Familiar ALCOA data integrity priciples specifically related to Electronic records management.
• Assist with equipment qualification AIQ, including writing the URS, validation programs and/or performance qualification programs.
• Write and revise SOPs for test methods, equipment maintenance, and general laboratory practices.
• Follow laboratory's quality control procedures and policies to document all quality control activities, instrument maintenance and calibration activities.
• Execute daily responsibilities and tasks to meet assigned schedule and deadlines.
• Flexible work hours to maintain critical testing during manufacturing runs.
• Follow and conduct laboratory established policies and procedures.
• Perform laboratory investigation procedures and interpret OOS and OOT test results.
• Trouble shoot analytical equipment and methods.
• Execution of validation plans as required, following ICH guidelines, cGMP and cGTP and other organizational standards.
• Promptly write reports on completion of execution of the validation/verification studies.
• Trend analysis of data from qualified methods.
• Actively makes recommendations following successful or unsuccessful validation or technical studies.
• Reference material/standards characterization and trending.
• Assist with technology transfer activities.
• Quality and technical review of analytical data and records.
• Assist the area management to ensure that the lab is always in a state of readiness for a given area of relevant standards and regulations.
• Work with other departments providing applicable assistance and/or serving as a subject matter expert.
• Capable of working in a fast-paced environment and communicate effectively with a diverse work group.
• Maintain and update on a regular basis, the departmental schedules to meet target goals.

Education

Required: Bachelor's degree in a related field.

Experience: Three years of relevant experience. With Master's degree, one year of experience required. May substitute required education degree with additional years of equivalent experience on a one to one basis.

Preferred: Two years of analytical testing or QC experience, preferably in flow cytometry panel and flow cytometry data analysis, technical qualification, cell therapy product characterization methods, and analytical technology transfer. Experience with method development and optimization are also a plus.

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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