Analyst I, QC Microbiology (Contract)

About Allogene:

Allogene Therapeutics is a clinical-stage biotechnology company with a single-minded focus on pioneering the development of investigational allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer. Led by world-class management with significant experience in cell therapy, our fully integrated, in-house team of researchers is dedicated to discovery and translational research, development, and cell manufacturing.

At Allogene, we are developing a pipeline of off-the-shelf CAR T cell candidates, with the goal of delivering readily available cell therapy faster, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.

About the role:

Allogene is seeking a highly motivated individual to join us as an Analyst I, QC Microbiology. This position provides Quality Control microbiological testing for clinical and commercial manufactured product, responsible for product testing, utility testing and environmental monitoring. This is a 6+ month contract opportunity in Newark, CA.

Responsibilities include, but are not limited to:

• Perform environmental monitoring of utilities and facilities and manage test data in LIMS
• Perform Endotoxin 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 Endotoxin 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 and toaddress deviations related to microbiological procedures.
• Follow GMP processes 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 1 year of experience in QC Microbiology laboratory setting
• Experience in the application of microbiological techniques such as air monitoring gases, water testing, surface monitoring.
• Experience in sterile gowning procedures, aseptic techniques and clean room operations is a plus
• Knowledge of GMP, SOPs and quality control processes
• Experience with LIMS (i.e. MODA) and Sievers M9s for TOC testing is a plus
• Proficient in MS Word, Excel, Power Point and other applications.
• Excellent interpersonal, verbal and written communication skills are 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.

We offer a chance to work with talented people in a collaborative environment. The expected salary range for this role is $28.00 to $32.00 per hour. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.

As an equal opportunity employer, Allogene 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. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.