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Scientist Bioanalytics Cell Therapy Jobs in San Mateo, California

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.
Director, Cell Therapy Drug Product Process Development
By Sana Biotechnology. At , South San Francisco, Ca $190,000 - $240,000 a year
Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment
Experience leveraging statistical Design of Experiments (DoE) strategies
Progressive years of industry experience in cell therapy drug product process development and/or manufacturing, including formulation, filling, finish, and cryopreservation
Proven ability to build, manage and mentor a team of talented scientists and engineers
Prior experience working on a clinical or commercial cell therapy manufacturing process
Extensive hands-on experience in formulation development and designing and scaling fill/finish and cryopreservation processes, such as aseptic filling and controlled-rate freezing
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++.
Lead Scientist - Cell Culture Media Development
By Alt Protein Careers At San Francisco, CA, United States
Deep knowledge in cell culture media composition, preparation, analysis, and cell-media interactions
Experience in managing a team is strongly preferred
Excellent communication skills and presentation skills
San Francisco, CA – 100% Onsite
Applying chemical analysis techniques to evaluate fresh, spent, and in-process media formulations
Implementing bioassays to analyze media and collect impactful metabolic data from our cell culture systems
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
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.
Scientist - Stem Cell Engineering And Disease Models
By Chan Zuckerberg Biohub Network At San Francisco, CA, United States
Competitive compensation and benefits commensurate with the experience
Author publications and manage collaborations
At least 4 years of experience with next-generation sequencing
Must be team-oriented, and have excellent written and oral communication skills
Experience with coding (Python, R, etc.)
Resources to disrupt and innovate at the frontiers of our knowledge of biology and disease
Field Application Scientist - Us Southwest - Advanced Cell Diagnostics
By Bio-Techne At San Diego, CA, United States
Technical customer support or application support experience a plus.
Committed to total customer satisfaction with outstanding interpersonal skills and professionalism.
Highly self – directed, conscientious, articulate, and possesses excellent presentation and teaching skills.
Data entry for all training and customer cases in Sales Force.
We offer competitive salaries along with extensive medical, vision, and dental plans for you and your family starting on day one!
Provide application assistance, product training and system troubleshooting for Advanced Cell Diagnostics scientific product lines via phone, email and on-site visits.
Analytical Development, Cell Therapy Sciences Internship
By Thermo Fisher Scientific At , San Francisco, Ca $22 - $25 an hour
Specific tasks will be tailored to the intern experience level and abilities
The intern will work under the close supervision of AD Scientists and Manager
Aligns with all company safety, training, and quality regulations (e.g., ISO compliance, GLP/GMP requirements, etc.) and procedures
Strong leadership and team building skills
Aptitude for working with hands and having laboratory experience may be beneficial
Requires a fundamental knowledge of laboratory equipment and techniques
Process Engineer I - Allogeneic Cell Therapy
By Kite Pharma At , Santa Monica, Ca
Fluent with Microsoft office application, statistical analysis tools (JMP/ Minitab) and data management tools.
Manages samples and inventory related to each experiment.
MS in Biomedical, Biochemical, Chemical Engineering, or related discipline with 0 years of experience in biotech/pharmaceutical process development
BS in Biomedical, Biochemical, Chemical Engineering, or related discipline with two years of experience in biotech/pharmaceutical process development
1-3 years of cell culture or cell therapy manufacturing & process development experience.
Hands on experience with automated single-use disposable cell therapy T-cell isolation, expansion, and harvest equipment/technologies.
Head Of Cell Therapy Manufacturing
By Takeda Pharmaceutical At , Thousand Oaks, Ca $165,000 - $236,000 a year
Experience in General Management to drive Plant performance and investments
Identify and develop potential successors for key management and expert positions.
Drive the cell therapy manufacturing operations following OpU goals, ensure robust processes, adequate life cycle management, and optimize yields and capacity.
Proven track record of successful leadership and project management in a manufacturing environment.
Continuous improvement knowledge; e.g., Black Belt/Lean/Six Sigma certification preferred
Manage Manufacturing budgets, resource allocation and timelines to ensure delivery of high-quality cell therapy products.
Scientist, In Vivo Biology/Gene Therapy
By Neurocrine Biosciences At San Diego, CA, United States
And 2+ years of experience in the handling and dosing of rodents in a laboratory setting OR
And some relevant experience preferred OR
And some relevant experience preferred
Working knowledge of stereotaxic surgery and/or AAV administration
Extensive hands-on knowledge of behavioral testing in a variety of assays
Strong knowledge of one scientific discipline
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, Qc Bioanalytics Jobs
By Pfizer At , Sanford
Oversee and guide lab analysts on continuous improvement tools such as standard work and visual management.
Oversee project management of all Data Integrity related activities with the relevant teams.
Manage multiple projects and ongoing work activities of moderate complexity within the division typically involving cross-functional representatives.
Demonstrated experience in Quality Control
Reasoning ability including strong analytical and problem solving abilities
Strong verbal and written communication skills
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 ...

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
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
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.
Cell Culture Scientist Jobs
By Pace® Analytical Services At Greenfield, IN, United States
2 years of experience preferred
Strong communication and lab documentation/reporting skills
Able to perform testing to SOP specifications
Highly organized with and attentive to detail
Availability to work short weekend shifts when project load requires
Cell Line Development Scientist
By Eurofins Lancaster Laboratories At Spring House, PA, United States
Additional responsibilities include mammalian cell culture, experimental design, data analysis, troubleshooting, participation in project teams and maintaining detailed records.
The work is highly collaborative; requiring excellent communication skills and a desire to be part of a team.
Must haves: mammalian cell culture, aseptic technique experience
Excellent full time benefits including comprehensive medical coverage, dental, and vision options
BS in Biotech or Cell Biology or other science related field
Monday - Friday, 8 a.m. - 5:00 p.m
Scientist I, Cell Biology
By Emulate, Inc. At Boston, MA, United States
Good organization and time management skills.
Update your knowledge of applicable industry best practices.
2 years of experience working in a Biosafety Level 2 laboratory environment.
At least 2 years of cell culture experience, preferably with human primary cells and/or stem cells.
Knowledge of statistics and using in vitro models is desirable.
Experience with immunofluorescent imaging techniques is desirable.

Are you a scientist looking to make a difference in the field of cell therapy? Join our team and help us develop innovative bioanalytics solutions that will revolutionize the way we treat diseases. We are looking for a creative and motivated individual to join our team and help us create a new era of cell therapy. If you are passionate about making a difference in the world of cell therapy, then this is the job for you!

Overview:

Scientist Bioanalytics Cell Therapy is a specialized role within the field of biotechnology. This position involves the development and implementation of analytical methods to assess the safety and efficacy of cell-based therapies. The Scientist Bioanalytics Cell Therapy is responsible for designing and executing experiments, analyzing data, and interpreting results.

Detailed Job Description:

The Scientist Bioanalytics Cell Therapy is responsible for developing and validating analytical methods to assess the safety and efficacy of cell-based therapies. This includes designing and executing experiments, analyzing data, and interpreting results. The Scientist Bioanalytics Cell Therapy will also be responsible for developing and maintaining laboratory protocols and procedures, as well as providing technical support to other scientists and researchers.

What is Scientist Bioanalytics Cell Therapy Job Skills Required?

• Knowledge of cell biology, biochemistry, and molecular biology
• Ability to design and execute experiments
• Ability to analyze and interpret data
• Knowledge of laboratory protocols and procedures
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Ability to troubleshoot and problem-solve

What is Scientist Bioanalytics Cell Therapy Job Qualifications?

• Bachelor’s degree in a relevant field, such as biology, biochemistry, or molecular biology
• At least two years of experience in a laboratory setting
• Experience with cell culture and cell-based assays
• Experience with analytical methods such as flow cytometry, ELISA, and PCR

What is Scientist Bioanalytics Cell Therapy Job Knowledge?

• Knowledge of cell biology, biochemistry, and molecular biology
• Knowledge of laboratory protocols and procedures
• Knowledge of analytical methods such as flow cytometry, ELISA, and PCR

What is Scientist Bioanalytics Cell Therapy Job Experience?

• At least two years of experience in a laboratory setting
• Experience with cell culture and cell-based assays

What is Scientist Bioanalytics Cell Therapy Job Responsibilities?

• Design and execute experiments to assess the safety and efficacy of cell-based therapies
• Analyze and interpret data
• Develop and maintain laboratory protocols and procedures
• Provide technical support to other scientists and researchers
• Troubleshoot and problem-solve