Details
Posted: 14-Mar-23
Location: Seattle, Washington
Type: Full-time
Salary: Open
Overview
Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.
With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world's leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world's deadliest diseases and make life beyond cancer a reality.
At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. These values are grounded in and expressed through the principles of diversity, equity and inclusion. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.
The Quality Control laboratory performs in-process and release testing in support of Human Gene Therapy Phase I/II clinical research studies.
We are looking for a dynamic, skilled, and detail-oriented candidate to join our team. The position will perform routine cell-based potency assays, as well as microbial safety assays utilizing ELISA, microscopy, and qPCR techniques. In addition, the position will be required to follow and maintain laboratory quality systems in our GMP environment. Eventually, the position may also be required to train on flow cytometry-based methods.
Responsibilities
Analytic Developer/Quality Control Associate I
Responsibilities:
The position will primarily focus on performing routine microbiological, flow cytometry and cell culture based potency assays in support of manufacturing and process development activities. The position will also perform method development including assay qualification and generation of approved test methods. Further responsibilities include sample receipt/distribution, communication with internal/external laboratories, environmental monitoring activities and maintenance of the lab equipment in state of regulatory
compliance.
Analytic Developer/Quality Control Associate II
Responsibilities:
- Perform in-process, lot release, and stability cGMP testing of raw materials and human gene therapy products
- Review assays performed by peers
- Write SOPs and test methods
- Perform deviation and out of specification (OOS) investigations
- Maintain laboratory cell lines
- Participate in environmental monitoring activities
- Maintain equipment
- Perform general activities in accordance to SOPs and laboratory quality systems
Qualifications
Analytic Developer/Quality Control Associate I
Qualifications (Minimum)
- At least a minimum of one year of experience in analytical methods used in QC release testing and characterization of immune cells and/or stem cells
- Hands on experience with analytical methods such as: quantitative PCR, genetic and proteomic profiling, ELISA, western blot, electrophoresis, and cell culture based functional assays (e.g. target cell killing, cytokine release)
- Experience in following and completing GMP test methods and documentation intended for product release testing and characterization as required under FDA and ICH guidelines
- Good communication skills and writing ability
- Familiarity with data analysis software packages and general statistical concepts and methods
- Bachelor's degree (or higher)
Analytic Developer/Quality Control Associate II
Qualifications (Minimum)
- Bachelor's degree in a life sciences field with 2+ years, preferably with a background in biologics and/or cellular therapeutics
- Hands-on experience with microtiter cell-based assays
- Hands on experience with analytical methods such as: quantitative PCR, genetic and proteomic profiling, ELISA, western blot, electrophoresis, and cell culture based functional assays (e.g. target cell killing, cytokine release)
- Experience with aseptic and cell culture techniques
- Experience with typical GMP Quality Systems (ex. Document Control, Deviations, CAPA, Change Control, etc.)
- Good written and oral communication skills
- Strong communication and writing skills with demonstrated ability to work in a dynamic team environment
Preferred Qualifications:
- Experience with cytotoxicity, bacterial endotoxin, and qPCR testing
- Experience in executing protocols for the qualification/validation of methods and equipment
- Experience with Environmental Monitoring (EM) programs
- MA/MS preferred
Fred Hutchinson Cancer Center has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations. As a condition of employment, newly hired employees must, prior to their first day of employment: Provide proof of being fully vaccinated against COVID-19 ; ORInitiate the accommodations process to request a religious or medical accommodation (medical accommodations require a healthcare provider's certification).
A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.
The annual base salary range for the I level position is from $64,233 to $96,349 and pay offered will be based on experience and qualifications.
The annual base salary range for the II level position is from $70,817 to $106,225 and pay offered will be based on experience and qualifications.
This position may be eligible for relocation assistance.
This position may be eligible for a sign-on bonus.
Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months).
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.
