Thermo Fisher Scientific Analytical Scientist III in Princeton, New Jersey
Job Title: Analytical Scientist II, Process Development
Requisition ID: 146338BR
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com .
How will you make an impact?
Thermo Fisher Scientific is making a significant investment in the dynamic and rapidly growing Cell Therapy space. The candidate will be a part of a Cell Therapy Analytical Development team and will be responsible for highly specialized technical research to support the development, optimization, qualification and execution of cell-based, nucleic acid-based, protein-based and chemistry-based assays that support quality control of cell therapy products under development and manufacturing. This position entails experience and understanding of analytical design and development in order to establish new analytical methods and standard procedures for cell therapy product characterization. These functions may include but are not limited to activities such as handling and processing a variety of cell types, characterization using cellular and molecular assays, FLOW cytometry, isolation and propagation of variety of human primary cells, technology transfer and design of technical documents.
What will you do?
Support efforts for development, validation and execution of a variety of analytical methods including but not limited to FLOW cytometry, real time (PCR qPCR, ddPCR), ELISA, plaque assays and cytotoxicity assays.
Establish methods for in process characterization and final product release for cell-based therapies.
Apply expertise in immunology, cell biology or molecular biology to analytical design and development, establish new analytical methods and standard procedures for product characterization.
Support the technology transfer of analytical methods to QC and assist QC with analytical method qualification and validation
Offer support the transfer of test methods from sponsors and partners.
Assess existing methods/processes and identify areas for further innovation and improvements (improved sensitivity, reduced turnaround time etc.)
Support Quality Control and Quality Assurance as necessary and participate in the technical assessment of Out of Specification and Non-Conforming investigations.
Utilize Design of Experiment (DOE) and Quality by Design (QBD) tools in process & assay design, development, qualification and validation.
Plan and implement resolutions to technical problems/issues
Author and review technical documents such as methods, qualification/validation protocols and reports.
Help in resolving technical challenges and support laboratory investigations.
Author SOPs, reports, technology transfer documentation, and other support documents for analytical services.
Understand project timelines and deliverables and plan/coordinate project work accordingly with departmental, functional and external stakeholders.
Maintain cell lines and lab equipment in the Analytical Sciences lab, share responsibility for lab management duties
Analyze data (including statistical analysis), present results and conclusions to the team.
Keep current on Environment, Health & Safety policies.
How will you get here?
*Bachelor's degree in immunology, cell/molecular biology or similar biological sciences is required. Master's degree in immunology, cell/molecular biology or similar biological sciences preferred. PhD in cell biology/molecular biology is ideal.
3 + years of relevant experience in immunology, cell/molecular biology a related field or industry required
3+ years of industry experience in analytical development of cell-based assays required.
Experience in Cell Therapy assay development is a plus.
Experience in GMP environment preferred
Experience in working in a multi-disciplinary team environment
Knowledge, Skills, Abilities
Understanding 'why' and not just the 'how' of processes and practices
Broad technical proficiency, ability to solve complex issues independently
Significant laboratory documentation experience
Familiar with GLP requirements; some knowledge of cGMP requirements of biopharmaceutical
Confidence and experience with closed and automated systems specific to Cell Therapy manufacturing
Mechanical Skills/ Analytical Skills/Method Automation
Analytical and Problem-Solving Skills - Able to troubleshoot critical issues or problems, and determine causes and possible solutions
Strong math skills
Strong prioritization skills
Extremely detail oriented
Able to read, write, communicate and carry out instructions in English
Excellent written and verbal communication skills
Ability to function in a rapidly changing environment & handle multiple priorities.
Able to recognize problems developing, not just occurring
Ability to work both independently and as part of a team and effective multi-tasking
** A flexible work schedule is required.
Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com .
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.