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Head Of Cell Therapy Manufacturing Jobs

Production Engineer, Cell Materials & Manufacturing
By Tesla At Fremont, CA, United States
Experience with process monitoring, statistical process control, process dashboards and their use in improving the precision and rigor of chemical processing
Experience with some or all of the following industries and production environments:
Family-building, fertility, adoption and surrogacy benefits
401(k) with employer match, Employee Stock Purchase Plans, and other financial benefits
Voluntary benefits to include: critical illness, hospital indemnity, accident insurance, theft & legal services, and pet insurance
Provide technical support to production teams on processing activities in a novel chemical plant
Quality Control Analyst- Cell Therapy
By Novo Nordisk At , West Lebanon
Bachelors in a scientific discipline, Associates in a scientific discipline (with additional experience) or equivalent level of knowledge, skills and abilities
Bachelors with 1 year of related experience or Associates with 2 years of related experience, or equivalent
Knowledge of laboratory practices required (such as aseptic technique, use of pipettes, pH etc.)
Good organization and documentation skills
Leading pay and annual performance bonus for all positions
34 Paid days off including vacation, sick days & company holidays
Manager, Manufacturing, Cell Therapy (12 Hour Shifts)
By Bristol Myers Squibb At , Devens, 01434
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Maintain training assignments to ensure the necessary technical skills and knowledge.
Manage the creation, implementation and compliance for all documentation, procedures and policies
Manage implementation and maintenance of appropriate training curricula
Assist in the setup of manufacturing areas and equipment/fixtures and perform facility and equipment commissioning, qualification and validation activities.
Writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
Production Engineer, Cell Manufacturing
By Tesla At , Austin
Experience with process monitoring, statistical process control, process dashboards and their use in improving the precision and rigor of chemical processing
Experience with some or all of the following industries and production environments:
Provide technical support to production teams on processing activities in a novel chemical plant
Develop operating procedures, safety protocols, and maintenance plans for large scale chemical process equipment.
Planning and coordinating operations of various unit operations, ensuring consistent flow while minimizing quality variability
Create sustainable data acquisition systems and monitor to present relevant high quality data visualization for team to accelerate development
Training Supervisor, Cell Manufacturing
By Tesla At , Austin
Experienced using a Learning Management System (LMS) preferred.
Work with Production and Quality Management, Leads and Workstation Trainers on implementing training related initiatives.
Work with management to determine training needs and determines subsequent training and development priorities.
4 years of supervisory experience or demonstrated proficiency performing similar duties/responsibilities preferred.
Lead internal training audits to ensure that training requirements are followed.
Partners with the Training Instructors to implement and train cross-functional teams on the certification system.
Associate, Cell Therapy Manufacturing (Contract)
By Allogene Therapeutics At , Newark, 94560, Ca $34 - $37 an hour
Timely completion of training assignments to ensure the necessary technical skills and knowledge are applied compliantly during GMP operations
Perform tasks in a manner consistent with safety policies, quality systems, and cGMP requirements
Update and revise manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements·
Must maintain and apply knowledge regarding donor information, screening and testing, labeling and product acceptability and release criteria
Bachelors or Associates in relevant science or engineering discipline with 0-2 years of experience in cGMP biologics or cell therapy manufacturing
Cell culture processing experience in handling and propagation of human primary cells is strongly preferred
Head Of Cell Therapeutics Research
By Chantibody Therapeutics Inc. At Menlo Park, CA, United States
Budget and Resource Management: Manage departmental budgets, allocate resources effectively, and prioritize projects based on their potential impact and feasibility.
Familiarity with regulatory requirements and guidelines relevant to cell-based therapies and biologics.
Excellent communication and presentation skills, with the ability to effectively communicate complex scientific concepts to diverse audiences.
Ph.D. in a relevant scientific discipline (e.g., Cell Biology, Immunology, Molecular Biology, Biotechnology) with a strong focus on cell-based therapies.
Ability to work collaboratively with internal and external stakeholders to drive research advancements and partnerships.
Head Of Manufacturing Jobs
By The Mullings Group At San Francisco Bay Area, United States
• Computer skills are needed, with experience using Microsoft Access, Word, Excel, PowerPoint, and Project
• Must have a thorough understanding of US FDA Quality System Requirements, ISO/EN 13485, and MDD/MDR requirements
• Must have a working knowledge of MRP systems
• Bachelor’s degree in engineering or related field or equivalent work experience required
• Review/approve product and process change control documentation and specifications.
• Review/approve manufacturing and inspection tool design, automation systems, and related system documentation.
Associate Director, Atc Cell Therapy Operations
By Iovance Biotherapeutics, Inc. At New York, United States
Meeting management skills and operational capabilities
Lead the TIL site qualification process that will use risk-based tools for qualification, training, monitoring and disqualification.
Contribute to training content development, review and creation of education materials.
Oversee Logistics, manages changes for the regional accounts.
Respond to every detour from established lifileucel standard of care pathway and commit to respond with utmost experience and collegiality
Participate in advisory board meetings to gain insight into future educational needs
Global Head Of Cell And Gene Manufacturing
By Sanofi At Waltham, MA, United States
Strong Communication and stake-holder management skills
Prior experience as biologics manufacturing site leader, facility design, supply chain management, operational excellence
Extensive prior experience (>10 years) managing manufacturing teams delivering clinical supplies complying with US/EU and other global requirements under cGMP conditions
Prior experience with Cell and Gene Therapy, vaccine, or biologics manufacturing
Prior experience in cell and gene therapy manufacturing operations
Responsible for managing manufacturing operations relating to the global internal and external clinical manufacturing
Head Of Manufacturing Jobs
By Aescape At New York, NY, United States
BS or MS in Engineering (or equivalent experience)
Experienced with product DFX processes (X=mfg, test, service, repair, installation)
Experience tracking labor efficiency and effectiveness throughout the product lifecycle, from NPI to EOL, and remake.
Don’t meet all the requirements?
Leading product DFX processes (X = manufacturing, test, service, repair & installation)
Establish and adapt common processes from lab to factories and field to streamline and optimize process and product performance
Head Of Manufacturing Jobs
By CrimsonXT At Tennessee, United States
Proven experience (10+ years) in manufacturing operations, preferably in the battery materials, energy storage, chemicals or related industries.
Strong knowledge of manufacturing processes and quality control practices.
Hands-on experience in implementing process improvements and lean manufacturing methodologies.
Excellent problem-solving and analytical skills with a data-driven approach.
Effective communication and collaboration skills to work with cross-functional teams.
Collaborate with cross-functional teams to develop manufacturing processes and procedures for battery material production.
Associate Director Global Regulatory Cmc - Cell Therapy
By Shepherd Regulatory Search At Greater Philadelphia, United States
Leads interactions with FDA and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments).
Provides CMC Regulatory leadership, serving as an expert for global regulatory CMC requirements and emerging trends for cell therapy products.
Plans, execute, and manages regulatory CMC submissions, including BLA/MAA, INDs, CTAs/IMPDs, briefing documents, and responses to queries.
Minimum of 10 years of pharmaceutical/biotech experience, including five years of Global Regulatory Affairs (CMC) experience.
Experience as a RA CMC product lead.
Experience in Cell or Gene Therapy.
Associate Director Global Regulatory Cmc - Cell Therapy
By Shepherd Regulatory Search At Greater Boston, United States
Leads interactions with FDA and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments).
Provides CMC Regulatory leadership, serving as an expert for global regulatory CMC requirements and emerging trends for cell therapy products.
Plans, execute, and manages regulatory CMC submissions, including BLA/MAA, INDs, CTAs/IMPDs, briefing documents, and responses to queries.
Minimum of 10 years of pharmaceutical/biotech experience, including five years of Global Regulatory Affairs (CMC) experience.
Experience as a RA CMC product lead.
Experience in Cell or Gene Therapy.
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.
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
Production Engineer, Cell Manufacturing
By Tesla At Austin, TX, United States
Experience with process monitoring, statistical process control, process dashboards and their use in improving the precision and rigor of chemical processing
Experience with some or all of the following industries and production environments:
Family-building, fertility, adoption and surrogacy benefits
401(k) with employer match, Employee Stock Purchase Plans, and other financial benefits
Voluntary benefits to include: critical illness, hospital indemnity, accident insurance, theft & legal services, and pet insurance
Provide technical support to production teams on processing activities in a novel chemical plant
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.
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,
Production Supervisor, Cell Manufacturing (Mrc), Gftx
By Tesla At , Austin, Tx

What to Expect As a Production Supervisor you will have the critical task of managing the priorities, equipment, and people associated with the production line. Your experience in fast-paced ...