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) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on demand, more reliably, and at greater scale to more patients.
About the Role:
Allogene’s Supply Chain organization is building a world class team that is focused on delivering potentially lifesaving therapies to patients. We are seeking a highly motivated leader to join us as a Associate, Materials Management. This role will be a hands-on role reporting to our Manager, Materials Management and is based out of Newark, CA. This is a contract position.
The primary objective for this person is to support GMP warehouse functional areas, including receiving, inventory control, materials management, and distribution. This individual must have significant experience in warehouse operations, technical skills (equipment operation, counting, space utilization, handling efficiency), knowledge of inventory management systems and software (SAP, WMS, MES, etc.), and strong interpersonal and communication skills.
Responsibilities include, but are not limited to:
· Support the warehouse operations team, ensuring safe, compliant execution of the on-the-floor warehouse operations in the cGMP commercial facility including receiving, put away, material transfers, component preparation in support of production related activities, and product shipping
· Maintain warehouse performance targets by participating in daily huddles (safety, quality, cost, performance, etc.)
· Investigate and resolve operational problems and/or compliance issues utilizing problem solving techniques (CFA/RCA, 5Why, Fishbone, KT, etc.,) to determine root cause.
· Implements corrective and preventative actions based on cross-functional problem solving and investigation findings.
· Adept at developing visual management tools to provide status updates on organizational performance.
· Achieves functional area goals as assigned and participates in functional and cross functional job rotations.
· Supports input assumptions associated with capacity and workforce planning; preemptively identifies constraints and risks.
· Support cycle count process to ensure accuracy and control of inventory volumes.
· Maintains inventory control throughout the Newark warehouse for all materials; per applicable procedures partners with cross-functional teams to ensure that ABC coding is periodically reviewed and accurate.
· Ensures that policies and procedures are in compliance with OSHA Standards.
· Ability to effectively lead continuous improvement projects with cross-functional team support.
· Accountable for process discrepancies in the warehouse and provide technical expertise to improve procedures.
· Initiation of deviations for non-conforming materials and operational anomalies.
· Comfortable authoring SOPs and associated cGMP documents.
· Accountable for reviewing and in some cases owning documentation associated with transfer protocols, validation protocols, standard operating procedures, and batch records.
· Supports internal and external audits, as well as SOX compliance audit reviews associated with internal controls.
· Other duties as assigned.
Position Requirements & Experience:
· High school diploma or equivalent + 3 years of GMP experience in biotechnology industry
· Experience with setting up a lean warehouse
· Proficient in SAP/WMS/MES
· Proficient in training/mentoring other Material Handlers
· Proficient at quality record documentation
· Experience with developing procedures and technical writing
· Inventory control experience (cycle counting, physical inventories) preferred.
· Ability to lift material up to 50 lbs.
· Experience and/or certification in operating material-handling equipment preferred.
· Extensive walking and repetitive physical motion (squatting, bending, lifting, climbing ladders) is required.
· Demonstrates ability to diagnose possible root cause failure modes of warehouse transactions
· 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 US.
We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected salary range for this role is $40.00 to $42.00 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, designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.
#LI - KD1 #LI - Onsite Read LessAbout Allogene:
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) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on demand, more reliably, and at greater scale to more patients.
About the Role:
We are seeking a highly motivated Senior Associate, Cell Therapy Manufacturing to join our team. You will work within the Manufacturing team in supporting our efforts in an exciting area of cancer immunotherapy. The successful candidate will have experience in a regulated biotech or pharmaceutical setting and will have proven competency and expertise in the GMP manufacture of cell-based therapies. The position will report to the Associate Director, Manufacturing and will support the successful tech transfer and operational readiness process, using knowledge of cGMP regulations to ensure manufacturing readiness. This position is based out of Newark, California location.
Responsibilities include, but are not limited to:
Perform process unit and support operations described in standard operating procedures (SOPs) and batch records including: PBMC, media and solution preparation; CAR-T cell drug substance preparation; and CAR-T drug product fill operationsAccurate and timely completion of documentation required by protocols, SOPs, and batch recordsMaintain aseptic technique during processing of products to ensure the integrity, viability and sterility of cell therapy products from PBMC thaw to final formulated drug product cryopreservationPerform tasks in a manner consistent with safety policies, quality systems, and cGMP requirementsTimely completion of training assignments to ensure the necessary technical skills and knowledge are applied compliantly during GMP operationsAssist in setting up manufacturing areas and equipment, including complex automated cell processing, cell expansion and filling equipmentUpdate and revise manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements·Routinely monitor, clean, prepare and operate processing and analytical equipment in Grade B/C areasFollow all cleaning and gowning procedures for the facilityPerform error free calculations of media component and cell concentration, dilution, viability during productionMust maintain and apply knowledge regarding donor information, screening and testing, labeling and product acceptability and release criteriaBe flexible and adaptable to schedule and procedural changes to ensure timely preparation of products with highest qualityMaintain current inventory of supplies kept in specified kitting and staging areas and CAR-T suitesOther duties as assignedPosition Requirements & Experience:
Bachelor’s or associate degree in relevant science or engineering discipline with at least 4years of experience in cGMP biologics or cell therapy manufacturingExperience with aseptic processing in Grade A biosafety cabinets and Grade B clean rooms and universal precautions for handling human derived materials in BSL-2 containment areasKnowledge of cGMP regulations and FDA guidance applicable to biologics and/or cell therapyCell culture processing experience in handling and propagation of human primary cells strongly preferredFrequent use of a computer monitor, keyboard and mouse and personal protective equipment Physical requirements of the role include lifting, carrying, pushing or pulling up to 30 pounds, frequent periods of sitting, walking, and standing, occasional climbing stairs or ladders, bending or stooping, crouching or squatting, occasional fine finger dexterity/ including grasping or pinching and color, vision, and depth perception required for inspection or test related jobsOccasional work in cold rooms and freezers and use of hazardous materials and chemicals requiredExcellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelinesAbility to work independently and as part of a teamStrong interpersonal skills including verbal and written communication are essential in this collaborative work environmentCandidates must be authorized to work in the U.S.We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected salary range for this role is $45.00 to $50.00 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, designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.
#LI-KD1 #LI-Onsite
Read LessAbout Allogene:
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) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.
About the role:
Allogene is seeking a highly motivated Senior Associate Scientist to support the development and characterization of clinical-scale manufacturing processes for Allogene’s CART therapies. This individual will contribute to the development, implementation and characterization of state-of-the-art processing technologies to deliver scalable and robust manufacturing processes, and support successful tech transfer for GMP manufacturing and release. This position will also contribute to the development of novel technologies and approaches to meet future CART manufacturing needs.
Responsibilities:
Actively contribute to development, implementation, characterization and successful execution of robust, state-of-the-art CART manufacturing processes.Execute and analyze Design of Experiments (DoE) studies to support process understanding, optimization, and characterization activities.Support clinical‑scale non‑GMP manufacturing operations for execution of BLA‑enabling process characterization activities.Support and contribute to process characterization efforts and continuous improvement initiatives aimed at enhancing CAR‑T manufacturing processes and capabilities (e.g., evaluation of process parameters, materials, closed or disposable systems, and operational workflows).Contribute to Project Technical Teams and communicate and collaborate effectively to ensure effective interactions with all stakeholder groups.Ensure high-quality, timely documentation in electronic laboratory notebooks and Technical Reports and contribute to Regulatory Filings and responses to Regulatory questions as appropriate.Present data/strategy to scientists (and management) in internal venues (technical meetings, Project Team meetings) as appropriate.Remain current with relevant cell therapy, immunology, and bioprocessing literature.Other duties as assignedRequirements:
BS in Chemical Engineering, Biochemistry, Molecular & Cell Biology, or Immunology or related degreeMS plus at least 2 years experience or BS with at least 5 years experienceA demonstrated foundational understanding of mammalian or primary cell culture, biochemistry, molecular & cell biology and immunology (required for enhanced product & process understanding).Experience with prior Gene & Cell Therapy manufacturing preferred, but not required.Experience with continuous manufacturing processes including operation in upstream genetic modification and bioreactor/WAVE expansion, and cryopreservation preferred.Experience in genetic modification of cells using gene edit and gene delivery technologies preferred, but not required.Experience in flow cytometry for T cells characterization preferred, but not required.Experience in FMEA, process characterization and DOE methodologies in biologics or cell therapy space preferred.Ability to work in a fast-paced, startup environment.Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.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.This is a 1-year contract opportunity with the possibility of extension or contract-to-hire.We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected hourly range for this role is $45 to $50 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.
#LI-Onsite #LI-TF1
Read LessAbout Allogene:
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) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.
About the role:
Allogene is seeking a highly determined, results-oriented, self-starter who demonstrates personal accountability for outcomes and is motivated by increasing levels of responsibility, to join a dynamic team responsible for successful development and characterization of clinical-scale manufacturing of Allogeneic Chimeric Antigen Receptor T-cell therapies (Allo CAR T™). The successful candidate will help to support appropriate flow cytometry-based and/or cell-based analytical methods for the characterization, release and stability testing of CAR T products. This position will also contribute to the development of novel technologies and approaches to meet future CAR T analytical needs and work in close collaboration with key stakeholders, including the CAR T Research and Process Development groups.
Responsibilities include, but are not limited to:
Actively contributes to successful and efficient execution of robust, state-of-the-art multicolor flow cytometry methods, cell-based potency assays and molecular assays for the characterization of CAR T manufacturing processes and productsProvide analytical support for the development and execution of Process Characterization and BLA-enabling activities, including qualification of in-process and release methods and tech transfer internally and externally in support of GMP manufacturing and release of clinical material.Contribute to project technical teams to ensure effective communication at all levels. Collaborate effectively to ensure productive interactions with all stakeholder groups.Demonstrate strong accountability, organizational and interpersonal skills, and apply sound scientific and technical experience.Ensure high-quality, timely documentation in electronic laboratory notebooks and technical reports which support regulatory filings.Present data/ strategy to scientists and management internally.Position Requirements & Experience:
Bachelor’s degree or master’s degree in immunology, cell biology or related field is required (or relevant experience).Laboratory experience in a variety of analytical methods for the characterization and release of cell-based therapies, include, but not limited to: multi-parametric flow cytometry-based assays for characterization/ release/ stability testing, cell-based cytotoxicity assays, cell-based proliferation assays and cytokine measurements. Hands-on expertise in handling and processing of primary peripheral blood mononuclear cells or cell culture and analysis of T cell subsets and subpopulations (desired).Proficiency in data analysis and interpretation using FlowJo would be advantageous.Proficiency in Spotfire or R a plusFamiliarity with cGMPs and relevant Regulatory Guidance documents.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.This is a 1-year contract opportunity with the possibility of extension or contract-to-hire.We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected hourly salary range for this role is $45 to $50 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.
#LI-Onsite #LI-TF1
Read LessAbout Allogene:
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) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.
About the role:
Allogene’s Manufacturing organization is building a world class team that is focused on delivering potentially lifesaving therapies to patients. We are seeking a highly motivated individual to join us as a Senior Engineer, Manufacturing Sciences and Technology. This role will be a hands-on role and will support technical and strategic initiatives to advance internal and external manufacturing activities from late-stage development through launch/commercialization.
The position is based at Allogene’s manufacturing facility in Newark, CA.
Responsibilities include, but are not limited to:
Support trouble-shooting and continuous improvement of GMP manufacturing outcomes both internally and with external manufacturersSupport development and execution of key PPQ-enabling activities, including Process Control Strategy, PPQ protocol, E&L assessments, etc.Implement and evolve integrated control strategy for allogeneic CAR-T therapies and critical starting materialsAble to apply and develop advanced technologies, scientific principles, theories and concepts to meet the needs of the Process Development and Manufacturing teams, including supporting technology transfersProvide reliable process requirement inputs to support business case and capital project decision-makingEnsure technical strong and compliant technical justifications for manufacturing deviationsIn-depth knowledge of GMP and regulatory expectations and experience with regulatory inspectionsWork with Quality, Facilities & Engineering, Process Development and IT to ensure cross-functional alignmentClosely partner with the Quality Assurance group, manage and ensure the timely review and release of productEngage with broader manufacturing team to enable accomplishment of department goalsOther duties as assignedPosition Requirements & Experience:
Bachelor’s degree in Science or Engineering with a minimum of 8 years of directly related GMP pharmaceutical manufacturing experience. Late-stage clinical and commercial experience preferred.Knowledge of pharmaceutical manufacturing processes. Cell therapy experience and/or direct experience with viral vector, gene-editing, or cellular starting material manufacturing preferred.Excellent written and verbal communication skillsExcellent organizational skills and an ability to prioritize effectively to deliver results within established timelinesAbility to work independently and as part of a teamAbility to travel up to 10%Candidates must be authorized to work in the U.S.We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected salary range for this role is $135,000 to $160,000 per year. 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.
#LI-ONSITE
Read LessAbout Allogene:
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) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.
About the role:
Allogene’s Manufacturing organization is building a world class team that is focused on delivering potentially lifesaving therapies to patients. We are seeking a highly motivated individual to join us as a Principal Engineer, Manufacturing Sciences and Technology. This role will be a hands-on role and will provide technical and strategic leadership to advance activities from late-stage development through launch/commercialization.
The position will be accountable for technical oversight of CAR-T PPQ planning and execution. The position could be based either at Allogene headquarters in South San Francisco or Allogene’s manufacturing facility in Newark, CA
Responsibilities include, but are not limited to:
In partnership with Quality, Process Development and Regulatory, develop strategy for Process Performance Qualification in support of licensing applicationLead development and execution of key PPQ-enabling activities, including Process Control Strategy, PPQ protocol, E&L assessment, etcWork with Quality, Facilities & Engineering, Process Development and IT to ensure cross-functional alignmentClosely partner with the Quality Assurance group, manage and ensure the timely review and release of productEngage with broader manufacturing team to enable accomplishment of department goalsOther duties as assignedPosition Requirements & Experience:
Bachelor’s degree in Science or Engineering with a at least 8 years of directly related GMP pharmaceutical manufacturing experience (direct experience with CAR-T manufacturing strongly preferred).Knowledge of pharmaceutical manufacturing processes (cell therapy experience preferred).Late-stage clinical and commercial experience (experience with CMC regulatory submissions preferred).Highly developed leadership skills with the ability to effectively organize and lead teams without direct reporting relationships.Excellent organizational skills and an ability to prioritize effectively to deliver results within established timelinesAbility to work independently and as part of a team, strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environmentAbility to travel up to 10%Candidates must be authorized to work in the U.S.We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected salary range for this role is $150,000 to $170,000 per year. 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.
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