Job Description

　　Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 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, or improving patient diagnostics and therapies, we are here to support them.

　　When you join the team at Thermo Fisher Scientific, you’ll do important work. Things like helping customers in finding cures for cancer, protecting the environment, or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals. You’ll also have the opportunity for continual growth and learning in an environment that will support your development.

　　We are seeking an energetic and enthusiastic individual with strong communication, leadership, technical and operational skills to join our growing BioProcess Sciences (BPS) team.

　　Job Title: Analytical Development Scientist III

　　Location/Division Specific Information : US - Massachusetts – Plainville – On-site

　　How will you make an impact?

　　In BPS, our goal is to develop, characterize and scale-up bioprocesses for robust manufacture of viral vectors to help our clients deliver lifesaving therapies to patients.

　　As analytical development scientist, You will plan, design, execute, and document analytical testing and method transfer activities. You will also act as domain expert in analytical development for viral vector while supporting detailed transfer and development of analytical methods from clients into Bioprocess Sciences lab. You will also be supporting assay transfer out to the QC for cGMP testing.

　　This is a hands-on position. The ideal candidate shall have excellent lab skills, strong documentation skills, ability to analyze and summarize data to draw conclusions, make recommendations, and tight-knit collaboration skills.

　　What will you do?

　　Lead transfer and establishment of already-developed analytical assays, particularly, titer using PCR, capsid titer using ELISA, % full capsid using Capillary electrophoresis, SDS-PAGE, HPLC, Analytical Ultracentrifugation, size/aggregate characterization using light scattering, and process impurities using dPCR/qPCR and Elisa.

　　Independently support the development, and establishment of one or more cell based analytical methods eg. TCID50, Infectivity assay, Potency assay, etc.

　　Develop platform assays for gene therapy characterization.

　　Mentor and coach junior team members

　　Independently develop, revise and review SOPs, work instructions, test record, test report

　　Independently support technology transfers from R&D to QC and/or from client to BPS

　　Work closely with R&D, manufacturing, quality and project management teams to execute assays that meet customer and manufacturing needs in support of department, site, and corporate objectives

　　Independently analyze data, present results and conclusions to the team

　　Responsible for some lab management tasks

　　Apply principles and practice of quality improvement

　　Keep current on Environment, Health & Safety policies, ensure safe environmental and working conditions in the Analytical Sciences labs

　　Collaborate with process development groups to effectively support process development/characterization testing and QC team for assay transfer for GMP testing.

　　Lead Practical Process Improvement (PPI) initiatives

　　How will you get here?

　　B.S. in Chemistry, Biochemistry, Engineering or related field with 5 yrs., or Masters with 2 yrs. of industrial experience or Ph.D.

　　Experience and skillset

　　Experience with AAV, LV and Gene and/or cell therapy preferred.

　　Track record with analytical development with deep expertise with assay development in PCR, ELISA, CE, SDS-PAGE and other relevant assays.

　　Experience with analytical method development, across various platforms, (e.g. ELISA, HPLC, DLS, Raman, Chromatography, etc.)

　　Experience handling third party assay laboratories, collaborations, and relevant bioanalytical vendors preferred.

　　Shown deeply understanding of global regulatory requirements including GLP, GCP and the clinical trial process.

　　While performing the duties of this job, the employee:

　　Will work in a dynamic environment and balance multiple priorities simultaneously!

　　Will be self-motivated and proactively drive efficient execution.

　　Will be encouraged to learn new software, processes, and tools quickly!

　　Will use outstanding equipment and instrumentation in daily manufacturing.

　　Will demonstrate flexibility with changes to working environment and deliver high quality results.

　　Will critically review processes and recommend improvements to supervisor/manager.

　　At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner, and safer.

　　Apply today! http://jobs.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 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.