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.
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:
Develop real time monitoring technologies for cell therapies by evaluating novel tools as well traditional process analytical technology tools.
Develop different in process analytics and analytical methods for on-line, in-line and at-line monitoring during process development with specific focus for cellular therapies
Use different spectroscopic methods (Raman, NIR, FTIR) for process monitoring of biologics such as mAbs, proteins, viral vaccines, or gene therapy vectors. Preferred experience with cell therapy products.
Use capacitance probes to monitor cells in real time and come up with new and advanced data analytic pipelines using advanced statistical and regression models using Python, R, Matlab and SIMCA.
Maintain strong documentation of experiments using electronic lab notebook systems.
Education and Experience:
Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
Sr. Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years')
OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years')
OR PhD
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:
Hands-on experience with evaluating and/or implementing different PAT tools for real-time monitoring in a bioreactor and deploying chemometric models for quantitative analysis of bioreactor status
Experience developing machine learning models such as Principal component analysis (PCA), partial least squares (PLS) regression, and other clustering methods
Experience with different programming languages such as Matlab, Python or R and analytical software such as JMP, SIMCA, Unscrambler, etc.
Understanding of bioprocessing, gene therapy process development, characterization, and manufacturing. Knowledge and experience with cell culture and bioprocess is a plus
Experience working with different kinds of bioreactors like AMBR15, AMBR250, and other 2L reactor systems is a plus.
Ability to work with a strong sense of urgency and can develop creative solutions to novel problems.
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!