QA/QC Lab Manager I
Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.
At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.
The Fred Hutch Quality Control (QC) department performs in-process and release testing assays for a wide range of Phase I/II clinical products manufactured in both the Cellular Processing Facility (CPF) and the Biologics Production Facility (BPF). Products range from autologous T-Cell therapies (CAR-T, T-Cell Receptors, and Tumor-Infiltrating Lymphocytes) to complex biological products including lentiviral vectors, fusion proteins and monoclonal antibodies. The team also qualifies test methods and equipment to support these activities and actively supports regulatory submissions.
Responsibilities
The Quality Control Manager reporting to the Head of Quality for the Therapeutics Product Program (TPP) will support the Phase I/II Cell Processing Facility (CPF) and Biologics Production Facility (BPF) operations. The QC Manager will interact with manufacturing personnel in the BPF and CPF, research scientists, physician investigators, Process Development, Quality Assurance and other scientific staff and external collaborators.
- Champion proactive identification and resolution of compliance gaps
- Create quality control programs as required
- Provide quality control support to multiple areas within both manufacturing facilities
- Support facility improvement projects
- Ensure management and control of critical equipment within the QC laboratories
- Aid in the enhancement of the Environmental Monitoring programs
- Oversee the implementation and continual improvement of the QC systems
- Define and report on performance metrics measuring lab quality. Advises staff on areas for improvement, QC focus areas and efficiency in the quality control process
- Oversees the effective training of staff within the QC department. Prepare written procedures and training material
- Act as subject matter expert for Out of Specification investigations. Serves as lead for discussions regarding QC testing or investigations as they relate to clinical studies
- Responsible for personnel management of quality control associates inclusive of personnel scheduling, time management, performance management and ensuring career development opportunities in order to encourage employee retention
Qualifications
Minimum Qualifications:
- BS or MS in Biology or related discipline.
- Experience working in a regulated GMP environment.
- Minimum of 5 years working in a quality role within a cellular therapy or biopharmaceutical organization.
- Strong communication and writing skills with demonstrated ability to work as an individual contributor and in a dynamic team environment.
- Ability to manage conflict.
- Ability to work as a team member and to work collaboratively with strong listening skills.
- Ability to translate strategic initiatives into tactical solutions.
- Must be knowledgeable of FDA cGMP regulations and guidelines.
Preferred Qualifications:
- Ability to utilize elements of Quality Risk Management to manage and control risk.
- Ability to effectively present complex data and strategy to large groups.
- Proven track record in developing or leading teams.
- Experience with flow cytometry, cell culture based functional assays (e.g. target cell killing, RT-PCR, ELISA, etc.).
- Expertise in qualification and validation of analytical methods and equipment under FDA/ICH guidelines.
- Experience generating documents intended for use in a GxP environment or regulatory filings inclusive of DMF, IND and/or CMC.
- Familiarity with data analysis/statistical software packages (e.g. FlowJo, Gen5, JMP, etc) desirable, but not required.
A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and anti-racism in your career or that will be made through work at Fred Hutch is requested of all finalists.
Our Commitment to Diversity
We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at hrops@fredhutch.org or by calling 206-667-4700.