Analytical Scientist Job Description
Location/Division Specific Information
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?
· Lead 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.
· Lead the technology transfer of analytical methods to QC and assist QC with analytical method qualification and validation
· Lead 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
· Serves as a technical resource for junior staff and leverages expertise in laboratory technology as a functional resource/trainer.
· Author and review technical documents such as methods, qualification/validation protocols and reports.
· Serve as an analytical subject matter expert to solve 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.
· Other duties as assigned.
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.
· 5-8 years of relevant experience in immunology, cell/molecular biology a related field or industry required
· 3-5 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
· MS Office
· Strong math skills
· Strong prioritization skills
· Extremely detail oriented
· Results driven
· Able to read, write, communicate and carry out instructions in English
· Strong communication (written and verbal)
· 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
· Strong interpersonal and communication skills, verbal and written
· Some travel is required (10-20%)
· A flexible work schedule is required.
· Ability to lift up to 25 lbs.