About City of Hope
City of Hope's mission is to deliver the cures of tomorrow to the people who need them today. Founded in 1913, City of Hope has grown into one of the largest cancer research and treatment organizations in the U.S. and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines , as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center at its core, City of Hope brings a uniquely integrated model to patients spanning cancer care, research and development, academics and training, and innovation initiatives. City of Hope's growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, andtreatment facilities in Atlanta, Chicago and Phoenix. City of Hope's affiliated group of organizations includes Translational Genomics Research Institute and AccessHope TM . For more information about City of Hope, follow us on Facebook , Twitter , YouTube , Instagram and LinkedIn .City of Hope's commitment to Diversity, Equity and Inclusion
We believe diversity, equity and inclusion is key in serving our mission to provide compassionate patient care, drive innovative discovery, and advance vital education focused on eliminating cancer and diabetes in all of our communities. Our commitment to Diversity, Equity and Inclusion ensures we bring the full range of skills, perspectives, cultural backgrounds and experiences to our work -- and that our teams align with the people we serve in order to build trust and understanding. We are dedicated to fostering a community that embraces diversity - in ideas, backgrounds and perspectives; this is reflected in our work and represented in our people.Position Summary
We are looking for a Sr. Associate of Quality Control in Cell and Gene Therapy Operations (CGTO) at City of Hope (COH). This role reports to the Director of Quality Control.
COH has a mission to transform the future of cancer care. In support of this mission, COH has over 20+ years of experience in GMP production of Cell and Gene Therapies holding >120 active INDs and supported by a 100+ person GMP team. This position will oversee 0-2 Associates in a 15+ person Quality Control team, with a work culture consistent with City of Hope values (including a sense of urgency, intellectual curiosity, excellence, and collaboration).
The successful candidate will be passionate about advancing to the clinic a broad variety of Phase I/II therapeutics. Projects include both autologous and allogeneic modalities for immunotherapies (e.g. CAR-T, CAR-NK, TILs), stem cells (e.g. iPSCs, MSCs, NSCs), and viral vector productions (e.g. Lentivirus, etc). Assay types focus primarily on flow cytometry and PCR, as well as setup or execution of standard compendial testing (i.e. sterility, endotoxin, mycoplasma).Key Responsibilities include:
Basic education, experience and skills required for consideration:
- Perform, or supervise, release testing following established Standard Operating Procedures for the testing of biological products.
- Complete all documents in compliance to cGMP.
- Create, review, and revise Standard Operating Procedures.
- Maintain current knowledge of analytical techniques and industry practices.
- Identify and adapt new analytical methodologies to enhance current capabilities.
- Qualify assays in a stage- and project-appropriate manner for product testing and write / edit associated technical reports.
- Participate in general laboratory activities as necessary.
- Attend and complete all mandatory trainings required by City of Hope and the Office of Quality Systems.
- Complete and maintain all training required to perform assigned tasks.
- Provide supervision to direct report(s), if any. Utilize proper managerial skills to accomplish assigned tasks.
- Make scientific presentations and progress reports to management team on a regular basis.
- Communicate with external vendors to obtain technical information as needed.
- Communicate with collaborators to discuss assay needs and status.
- Cooperate with Quality Assurance group to ensure the quality of product and cGMP compliance, as well achieving compliance with all Federal and State accrediting agency requirements.
Preferred education, experience and skills:
- Bachelor of Science (BS) degree in scientific or engineering discipline.
- 9+ years of relevant work experience with BS or MS degree.
- MS or PhD in scientific or engineering discipline.
- Cell culture experience.
- Strong background in multi-color flow cytometry.
- Preferred background in PCR.
- Excellent written and verbal communication skills.
- Strong organizational skills and demonstrated ability to meet deadlines in a fast-paced environment.
- Analytical and critical thinking skills.
- The estimated pay scale represents the typical [salary/hourly] range City of Hope reasonably expects to pay for this position, with offers determined based on several factors which may include, but not be limited to, the candidate's experience, expertise, skills, education, job scope, training, internal equity, geography/market, etc. This pay scale is subject to change from time to time.
- As a condition of employment, City of Hope requires staff to comply with all state and federal vaccination mandates.
City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.