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Cell Therapy Associate Scientist Jobs

Director Of Regulatory Affairs (Cell Therapy)
By GQR Global Markets At San Francisco Bay Area, United States
Assist in organization and management of staff within the RA group, including coaching, career development and oversight of work, as required.
Depth Knowledge of GLP and GCP regulatory requirements in domestic and globally.
Manage all aspects of nonclinical and clinical regulatory strategy development for products (early- to late-stage/registration/post-market).
Prior experience with cell or gene therapies (preferred)
Prior experience in oncology drug development
10+ years working within the biotech/pharmaceutical industry. 8+ years of pharma and/or biotech regulatory CMC-experience.
Scientist/Sr. Scientist - Stem Cell/Epigenetics
By Epitor At New York, NY, United States
PhD in Biochemistry, Bioengineering, Molecular Biology or related biomedical science field (neuroscience experience preferred)
Hands-on experience with NGS-based workflows
Experience with AAV or Lentiviral production
Detail-oriented with exceptional organizational and communication skills
Interest and experience mentoring junior scientists
Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company
Recipe Author, Cell Therapy Network
By Bristol Myers Squibb At Tampa, FL, United States
Support a knowledge management strategy including generating training content and mentoring
Support global recipe management strategy to maximize reuse of recipes and/or recipe segments across sites
Gather and manage requirements around batch reports that relate to the Review by Exception and Release by Exception strategies
Strong knowledge of regulatory landscape and demonstrated experience with software validation.
Partnering with Supply Chain, MS&T, Quality, and Manufacturing Operations to understand business requirements
Support strategy for collecting end user feedback and improving the usability and user experience of the overall EMES solution
Research Scientist I/ Research Scientist Ii, Oncology Cell Therapy Innovation
By BioSpace At Boston, MA, United States
Demonstrate broad technical program knowledge
Demonstrate effective project engagement skills
Identify, plan and execute novel scientific projects and may manage the work of others a direct or matrixed structure
Independently manage workload and expectations
Receive high level instructions on all work, determine methods on new assignments, work closely with manager, may manage junior staff
A minimum of 0- 2+ years of relevant pharmaceutical industry/academic experience is required after graduation.
Scientist Or Research Associate - Single-Cell Genomics And Multi-Omics
By Zafrens At San Diego, CA, United States
Experimental design, primer design and qPCR, with experience in data analysis
Basic microscopy and fluorescent microscopy knowledge
Strong background of molecular biology and cell biology techniques
Strong background with NGS library prep applications and single-cell RNA-seq workflows
Exposure to higher-complexity genomics workflows like ATAC-seq, Perturb-seq and Gro-seq
Assist with troubleshooting of methods
Manufacturing Associate, Cell Therapy
By Bristol Myers Squibb At , Summit, 07901, Nj
Motivated, team consciousness individuals are needed to fulfill job requirements.
Or Operations experience or High School diploma/GED and 4 years of Manufacturing or Operations experience.
or Operations experience or High School diploma/GED and 4 years of Manufacturing or Operations experience.
Production of blood component lots through selection, activation, transduction, cell culture, harvest, and cryopreservation.
Aseptic technique is required for most activities: tube welding, connections, and transfers, at minimum.
Weighs and measures in-process materials to ensure proper quantities are added/removed.
Scientist, Research (Prevention & Beta Cell Survival)
By JDRF International At New York, NY, United States
Serving as liaison for other JDRF teams including Marketing and Communications, Industry Partnerships, and Clinical Trial Management.
Strong collaborative skills including the ability to manage cross-functional teams and external alliances.
Maintaining up-to-date scientific knowledge in T1D-relevant areas of human genetics, antibody-based diagnostic technologies, and beta cell stress for scouting new opportunities.
Minimum of 4 years post-graduate experience with significant experience in autoimmune and/or regenerative medicine disease research areas.
Hands-on experience in supporting programs in disease prevention, autoimmunity and/or beta cell regeneration.
Being a critical and strategic thinker to maintain an active and successful research portfolio.
Scientist, T-Cell Immunotherapy Jobs
By BioSpace At Arcadia, CA, United States
Prior experience/ knowledge in scaling up lentiviral and CAR-T production process is a plus.
Manage the work of multiple late preclinical stage clients effectively to drive projects to completion
Ability to stay organized, prioritize tasks, manage time efficiently, and provide creative solutions to meet program needs
Excellent interpersonal, verbal, and written communication skills
Experience in engineering T or other immune and tumor cell types using retro/lentiviral/nonviral platforms and downstream functional assays
Experience with transfection, electroporation, and transduction methods
Manager, Csv, Cell Therapy
By Bristol Myers Squibb At , Summit, 07901, Nj
Develops protocols, and associated reports while adhering to a change management process.
Experience executing equipment qualification documents
Supports the execution of equipment qualifications and validation protocols
Supervises vendors for qualification functions.
Supports calibration, equipment qualification and validation activities.
Develops validation/qualification deliverables such as Validation Plans,
Associate Director (Cell Therapy Manufacturing Logistics)
By AstraZeneca At , Gaithersburg, 20878, Md
Experience leading supply planning for a biotech manufacturing facility
Experience building and leading a team of direct reports
Experience working in a cGMP environment
Excellent collaboration and communication skills
Experience establishing and leading supply planning for cell therapy manufacturing (autologous and allogeneic)
Experience supporting supply of clinical cell therapy products to multiple regions of the world
Cell & Gene Therapy Clinical Project Manager Ii (Sponsor Dedicated/Remote)
By Syneos Health Clinical At , Remote $85,500 - $175,000 a year
Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience.
Clinical research organization (CRO) and relevant therapeutic experience preferred. Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
Lead project team to ensure quality, timelines and budget management.
Responsible for study management components of inspection readiness for all aspects of the study conduct.
Prepare project management reports for clients and management.
May be required to line manage other project management team members and clinical monitoring staff.
Research Scientist Ii: Cell Engager Therapies: Invitro/Exvivo Cell And Functional Biology
By Takeda Pharmaceutical At , Boston, Ma $130,200 - $186,000 a year
Self-motivated, collaborative with excellent time management and organizational skills
Use of scientific databases and application for data management and data analysis
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Uses defined practices and theoretical knowledge to perform analysis, interpret results and determine appropriate action
Demonstrates theoretical knowledge of cell engager platforms
Demonstrates in-depth technical knowledge within various assay development platforms
Head Of Quality - Cell Therapy
By Takeda Pharmaceutical At , Thousand Oaks, Ca $165,000 - $236,000 a year
Prior leadership and project management experience in a manufacturing environment.
Experience in General Management to drive Plant performance and investments
Drive the local cell therapy Quality organization following OpU goals, provide processes, life cycle management, and optimize yields and capacity.
Continuous improvement knowledge; e.g., Black Belt/Lean/Six Sigma certification would be ideal
Manage Quality budgets, resource allocation and timelines to ensure delivery of high-quality cell therapy products.
Solid professional experience in cell therapy clinical or commercial manufacturing industry, including experience in batch disposition and analytical techniques.
Clinical Scientist, Cellular Therapy
By Bristol Myers Squibb At Summit, NJ, United States
Basic planning/project management skills (develop short range plans that are realistic and effective)
Provide regular and timely updates to manager/management as requested
Develop Data Review Plan in collaboration with Data Management
Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
Basic knowledge skills to support program-specific data review and trend identification
May co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members
Cell Therapy - Recipe Analyst
By Bristol Myers Squibb At Tampa, FL, United States
Support a knowledge management strategy including generating training content and mentoring
Support global recipe management strategy to maximize reuse of recipes and/or recipe segments across sites
Knowledge of regulatory landscape and demonstrated experience with software validation.
Configure recipes using following process Partnering with Supply Chain, MS&T, Quality, and Manufacturing Operations to understand business requirements
Support strategy for collecting end user feedback and improving the usability and user experience of the overall EMES solution
Promote compliance with data integrity and computer system validation requirements and regulations
Head Of Quality, Cell Therapy Manufacturing, Raritan
By Johnson & Johnson At , Raritan, Nj $160,000 - $276,000 a year
Proven people management and Quality leadership experience is required
Leads the site management review of Quality compliance and operational KPIs at the manufacturing facility; ensures timely mitigation of unfavorable trends.
Provides leadership and builds an exceptional team to manage the Quality functions, including hiring, mentoring, and developing.
Manages team of senior leaders and professionals within Quality. Hires and develops employees within Quality team.
Performs tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
A minimum of 12 years of experience in Quality Assurance/ Quality Systems related to manufacturing is required
Senior Project Manager, Cell Therapy
By Bristol Myers Squibb At , Devens, 01434, Ma
Excellent organizational and time management skills.
Good facilitation, change management and interpersonal skills required.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Use change management methods to mitigate barriers to improvement efforts.
Use of lean tools such as Process mapping, visual management, value stream mapping.
Must be competent in Project Management tools and methodologies such as MS Project.
Associate Cell Materials Engineer, Cell Manufacturing
By Tesla At , Fremont, Ca

Deep technical background and practical training in chemistry, chemical engineering, materials science / metallurgy, and data science / computer science

Proactive, Self-driven, Risk-taking, and able to learn from failure and mistakes to fast improve

Director, Qa Operations, Cell Therapy
By Bristol Myers Squibb At , Libertyville, Il
A minimum of 10 years experience in biopharmaceutical quality with a minimum of 6 years of increasing management responsibility.
Extensive and proven experience in FDA (or other major regulatory authority) Preapproval Inspection preparation and management is essential.
Ensures that all personnel have adequate training, education and experience to perform their GMP related job function effectively.
Experience in building and growing an organization into a high-performing team.
Knowledge of cell therapy, biologics manufacturing or analytical testing is highly desirable.
Extensive knowledge of EU and US cGMP regulations and guidance.
Clinical Cell Therapy Associate - Gmp Laboratory
By MD Anderson Cancer Center At , Houston, 77030, Tx
Perform error free calculations, including, but not limited to infusion cell doses, viabilities, dilutions and cell concentrations.
Performs basic technical cell manipulation and testing procedures on irreplaceable cellular products.
Communicate with physicians/investigators, nurses, donor coordinators, internal and external testing laboratories and/or transplant facilities to ensure timely quality patient care.
Minimum Salary: US Dollar (USD) 36,500
Midpoint Salary: US Dollar (USD) 54,500
Maximum Salary : US Dollar (USD) 73,000