Senior Specialist, QC Environmental Monitoring and 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 world-class 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.
We are seeking a highly motivated individual to join us as a Sr. Specialist in the QC Microbiology Laboratory, supporting the Newark Quality Control Organization. In this role you will support, perform and / or coordinate standard microbiology tests as well as environmental monitoring for clinical and commercial manufacturing of final drug product in a GMP work environment. The selected individual will be responsible for environmental monitoring programs, raw material testing, in-process and final product testing. Candidates must be well versed and be able to execute various microbiological techniques including rapid microbiology test methods, and qualifying environmental monitoring processes with reference to cell therapy products.
Responsibilities include, but are not limited to:
- Establish, validate, and sustain an environmental monitoring program
- Work with internal and external resources to maintain the laboratory in an optimal and compliant state.
- Assist with the validation of rapid release microbiological methods in QC.
- Monitor and trend data
- Assemble reports on findings from environmental monitoring of Allogene’s cGMP facility. Frequently update management on environmental trends. Implement corrective action plans, when necessary.
- Support generation of CoAs for product release
- Assist in the preparation of dossiers and data packages for interactions between Allogene and Regulatory agencies.
- Interact with Inspectors from Regulatory agencies and participate in internal and Pre-Approval Inspections.
- Develop, revise and review SOPs, qualification/validation protocols and reports.
- Assist in investigations regarding out of specifications (OOS) results. Address and manage deviations related to micro processes and / or procedures. Provide updates at daily and weekly meetings.
- Monitor the GMP systems currently in place to ensure compliance with documented policies.
- Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
- Coach and train other analysts to qualified level.
- Lead method validation and transfer activities for the QC Microbiology group and support instrument qualification activities. Serve as Subject Matter Expert (SME) for the group.
- Contribute to continuous improvement opportunities for methods optimization, coordinating validation, and drafting SOPs, where necessary. Troubleshoot methods and analytical instrumentation; improve existing methods to optimize efficiency wherever possible. Establishes/maintains and minimizes workload, streamlining existing systems and ensuring adherence to all appropriate internal and external guidance.
- Maintain close interaction and communication with various cross-functional groups within and outside of the Quality Control Microbiology organization to ensure on-time and dependable related decisions.
- In conjunction with the Validation team, evaluate new technologies relevant to the Microbiology area.
- Represent QC Microbiology at operational and cross-functional meetings; prepares and presents information; provides decision making support at meetings and disseminates information back QC Micro Lab.
- Participate in Technology Transfers, New products introductions, microbiology methods qualifications and method validations, as required.
- Gather metrics information for use in continuous improvement of areas of responsibility.
- Perform other duties within QC, as required.
Position Requirements & Experience:
- Bachelor Degree (BS) in Microbiology (preferred) with 10+ years, Masters in Science (MS) with 7+ years, or Ph.D. with 4+ years of QC Microbiology laboratory experience
- Must have experience with Quality Systems such as Laboratory Investigations, Deviations, Full Investigations, CAPA, Change Control and Risk Assessments Tools.
- Experience authoring SOPs, protocols, and technical reports to support operations within QC Microbiology Laboratories.
- Experience in techniques such as air monitoring, water testing, surface monitoring, Sterility tests, Bacterial Endotoxins, and genus and species identification of microorganisms.
- Oversight over external contract testing laboratory
- Working knowledge of regulatory requirements (21 CRF Part 11/210/211) and trends
- Strong knowledge of GMP, SOPs and quality control processes.
- Working knowledge of aseptic manufacturing.
- Equipment and utilities IQ/OQ/PQ/PV.
- Proficient in MS Word, Excel, Power Point, and other applications.
- Strong written and verbal communication skills.
- Ability to communicate and work independently with scientific/technical personnel.
- Experience in the biotechnology and/or pharmaceutical industry
- 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.
- Experience leading projects desirable
- 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.