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
Scientist - Gene Therapy, Research & Development
By STRM.BIO At Cambridge, MA, United States
Exceptional communication, writing, organizational and time management skills
PhD and 0-4 years of postdoctoral experience in a relevant discipline with strong foundational knowledge of EV biology and EV experimentation
Maintain comprehensive and up-to-date knowledge of extracellular vesicle biology, extracellular vesicles as therapeutics, and novel genetic engineering approaches
Hands-on experience in isolating, characterizing and manipulating EVs in vitro and in vivo
Proficiency with Microsoft Office suite, with excellent PowerPoint and Excel skills
Experience in hematopoietic stem cell biology and hematologic diseases
Senior Scientist/Principal Scientist, Cell-Based Assays
By Garuda Therapeutics At Cambridge, MA, United States

Garuda Therapeutics, a biotechnology company focused on developing off-the-shelf human hematopoietic stem cell-based cellular therapies, is seeking a highly motivated senior / principal scientist to ...

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
Research Scientist - Qc, Gmp, Cell Culture
By Thermo Fisher Scientific At , Boston, 02210
Previous industry experience that provides the knowledge, skills, and abilities to perform the job:
Shows initiative; acts independently with management approval.
Ability to perform method development transfers and qualifications.
Improving the laboratory—including managing reagents, materials, improving lab flows, et cetera—with minimal managerial support.
Bachelor''s degree or equivalent and relevant formal academic / vocational qualification
Experience in a commercial QC lab setting.
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
Specialist, Quality Assurance Incoming Material Disposition, Cell Therapy
By Bristol Myers Squibb At , Devens, 01434, Ma
Works in electronic systems such as SAP, Learning Management, and Document management
Any combination of education, experience, and military service in line with recommendations above will be considered.
Experience in a laboratory, manufacturing, quality, or warehouse environment desired.
Previous work/academic experience where attention to detail and personal accountability were critical to success.
Strong communication skills and the ability to follow written and verbal instructions.
0-2 years of directly relevant experience in a regulated cGMP environment.
Senior Specialist, Quality Assurance Investigations, Cell Therapy
By Bristol Myers Squibb At , Devens, 01434, Ma
Must have knowledge and experience with cGMP manufacturing, quality, and compliance as well as US and global cGMP requirements.
Excellent verbal and written communication skills with ability to prepare written communications and communicate problems to management with clarity and accuracy.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
Able to recognize conflict and escalate to management.
Demonstrates a high degree of attention to detail, with strong documentation expertise. Able to effectively multi-task and demonstrate strong organizational skills.
Working knowledge of applicable business systems including SAP, LIMS/Celabs, Maximo and/or Veeva Vault.
Research Scientist Ii: Cell Engager Therapies: Invitro/Exvivo Cell And Functional Biology
By Takeda At Boston, MA, United States
Self-motivated, collaborative with excellent time management and organizational skills
Use of scientific databases and application for data management and data analysis
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
Strives towards expanding scientific knowledge in immunology
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
Associate Scientist - Cell Culture, Vaccine R&D
By Pfizer At Pearl River, NY, United States
Exercise and build basic team effectiveness skills {e.g., commitment, feedback, consensus management} within the immediate work group.
Perform job responsibilities in compliance with current Good Manufacturing Practices/ Good Laboratory Practice (cGMP/GLP) and all other regulatory agency requirements.
Collect and analyze data on a per project basis to support troubleshooting, qualification and other lab projects.
Bachelor's Degree in the Science field with 0-2 years relevant experience
Laboratory experience in a relevant field of science
Good verbal and written communication skills
Senior Scientist, Stem Cell Manufacturing
By InVitro Cell Research, LLC At New York City Metropolitan Area, United States
Ensure manufacturing and QC SOPs are followed and work closely with ICR's QC Manager
A MS or PhD and at least 3 years of experience in cell manufacturing under GMP conditions; industry experience preferred
Position title and compensation are commensurate with experience.
Optimize cell and stem cell production protocols, including advising on scale-up process development
Troubleshoot issues with manufacturing pipelines and conduct failure analyses when needed
Contribute original research to ICR's regenerative medicine goals
Staff Scientist, Manufacturing Science & Technology, Cell Culture
By BeiGene At Hopewell, NJ, United States
Project management skills related to internal and external teams
Participate in and support on-site supervision and management of contract employees or third parties as required by BeiGene.
Knowledge of drug preclinical, clinical and commercial requirements.
Broad knowledge of drug development, CMC, MST, preclinical and clinical requirements.
Any other assignment as is determined by the manager.
8 plus years overall experience is preferred.
Associate Scientist/Scientist, Process Development, T Cell Immunology
By BioNTech SE At Cambridge, MA, United States
Ability to balance independent execution with strategic contributions and project management.
Significant experience with mammalian cell culture systems, preferably with lymphocytes
Excellent attention to detail, excellent written and oral communication skills
Experience with scalable, closed-system cell culture technologies.
Experience with molecular biology and/or cell engineering
Experience with multicolor flow cytometry and other immune related assays
Single-Cell Bioinformatics Scientist Jobs
By Zafrens At San Diego, CA, United States
2 years of hands-on experience turning FASTQ files into counts tables using standard tools (e.g. STAR, kallisto, Seurat, scVI)
2 years of experience programming in Python
6 months of hands-on experience developing models for atypical counts data
6 months of experience building JavaScript applications to interact with analytical results
Strong experience in analyzing next-generation sequencing data, RNAseq, single-cell sequencing data, network analysis and/or statistical genetics.
Strong programming skills using R, Python, or C++.
Research Associate Scientist, Cell Therapy Innovation
By Takeda At Boston, MA, United States
Develop intricate experimental protocols and advance the project while internally analyzing, interpreting, and reporting findings to managers and project teams.
MS in a scientific discipline (or equivalent) with 3+ years relevant experience, or BS with 5+ years relevant experience
Previous experience working in lab setting.
Experience with non-viral gene delivery systems using EP, cell transfection, virus transduction, and CRISPR gene editing is strongly preferred (Electroporation).
Experience with CliniMACS Prodigy, CliniMACS plus, LOVO, or Sepax is a plus.
Implement project assignments in conjunction with coworkers and departmental teams, taking ownership of the technical components of the task.
Research Scientist I, Oncology Cell Therapy Innovation
By Takeda 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.
Cell Culture Scientist Jobs
By Proclinical Staffing At Wilmington, DE, United States
1- 5 years of experience working in cell culture process development/ manufacturing support in a biopharmaceutical industry.
Hands-on experience with cell culture process development, manufacturing support or GMP manufacturing, troubleshooting, authoring and review of batch record is essential.
Previous experience of working on several projects running simultaneously while working independently as well part of a team is essential.
Experience in GMP cell culture manufacturing operations or manufacturing support is beneficial.
Previous experience with authoring and/ or review of CMC sections for regulatory submission is beneficial but not necessary.
Executes experiments to support early and late-stage cell culture process development, scale up, characterization and validation activities as necessary.
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.