Analyst, QC Microbiology
Quality | Newark, CA | Full Time
About Allogene Therapeutics, Inc:
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
Allogene is seeking a highly motivated individual to join us as an Analyst, QC Microbiology. This position provides Quality Control microbiological testing for clinical and commercial manufactured product, responsible for product testing, utility testing and environmental monitoring.
Responsibilities include, but are not limited to:
- Perform environmental monitoring of utilities and facilities
- Perform LAL and Sterility testing of final drug product per compendial methods
- Perform media growth promotion, gram staining, and microbial ID test methods of isolates per compendial methods
- Perform TOC testing of water samples
- Perform bioburden and LAL testing of incoming raw materials
- Work with internal and external resources to maintain lab in an optimal state
- Monitor and trend data
- Assemble reports on findings from environmental monitoring of Allogene’s cGMP facility, frequently update management on environmental trends and implement corrective action plans when necessary
- Revise and review SOPs
- Assist in investigations regarding out of specifications (OOS) results, address and manage deviations related to micro procedures.
- Monitor the GMP systems currently in place to ensure compliance with documented policies
- Gather metric information for use in continuous improvement of areas of responsibility
- Perform other duties as required
Position Requirements & Experience:
- Bachelor’s degree in Microbiology preferred with 2-4 years of microbiology laboratory experience
- Experience in the application of microbiological techniques such as air monitoring gases, water testing, surface monitoring, genus and species identification of isolates.
- Experience in aseptic techniques and clean room operations
- Experience in sterile gowning procedures
- Strong knowledge of GMP, SOPs and quality control processes
- Experience with EM System- MODA and Sievers M9s for TOC is a plus
- Proficient in MS Word, Excel, Power Point and other applications.
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Ability to work independently and as part of a team.
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
- Candidates must be authorized to work in the U.S.
As an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact the careers email at www.allogene.com for assistance.
For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.