Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our customers to make the world healthier, safer, and cleaner.
Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.
Key responsibilities:
Coordinate sample characterization (sample tracking, inventory, and testing) and data management/data integrity initiatives
Develop and execute routinely automated test methods in support of Cell Therapy Process Development and some gene therapy activities (e.g., Flow Cytometry, Cell Culture, Cell differentiation assay, Cell based Potency Assay, Immuno-based assays, and viral genome titer ddPCR etc.).
Involve in troubleshoot, optimize, and trend assay performance
Involve in writing the technical report, project progress reports, analytical development protocols and reports.
Involve in method transfer assays to QC if needed.
Maintain excellent written documentation (e.g. lab notebook and test forms)
Assist with lab organization and compliance with lab safety protocols
This position is lab-based and requires 80% lab testing and 20% sample/data management.
Education and Experience:
Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
Associate Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0-2 years')
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
At least 1 year of relevant industry experience in the cell and/or gene therapy space
Relevant industrial laboratory experience in assay/analytical development of cell and/or gene therapies
Experience with assay development for assessment of cell therapy-based products including identity, purity, and potency
Familiarity with automated assay development and robotic liquid handler (Hamilton and TECAN) operations.
Experience with sample management and ELN/LIMS systems strong preferred
Hands-on experience with the following techniques: Flow Cytometry, Cell culture, Cell based Potency Assay, ELISA, and ddPCR.
Ability to utilize Microsoft Excel and Word to perform tasks
Ability to independently optimize analytical methods
Excellent written and oral communication skills
Time management and project management skills
Problem solving and troubleshooting abilities
Ability to work in a collaborative work environment with a team
Working Environment:
Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary and/or standing for typical working hours.
Able to lift and move objects up to 25 pounds
Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with
proficiency.
May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
