Analytical Development - Sci III

Thermo Fisher ScientificPlainville, MA
1d$91,000 - $135,000Onsite

About The Position

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 CMC Development team. In CMC Development, 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 a Scientist III in analytical development (AD), 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 be supporting assay transfer out to 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.

Requirements

  • B.S. in Biochemistry, Biophysics, Engineering or related field with 7 yrs., Masters degree with 3 year experience, or PhD with 1 year experience
  • Experience with analytical assays for mass spectrometry ideally in gene therapy.
  • Knowledge and experience with chemistry, analytical chemistry, biophysics, and/or virology is highly desirable.
  • Broad technical proficiency, ability to solve complex issues independently and as a part of a team
  • Significant laboratory documentation experience
  • Familiar with GLP requirements; some knowledge of cGMP requirements of biopharmaceutical manufacturing
  • Ability to function in a rapidly changing environment & handle multiple priorities
  • An onsite, flexible work schedule is required
  • Ability to lift up to 40 lbs
  • 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.

Responsibilities

  • As a bench scientist, independently support the development, assessment and execution of one or more analytical methods that is grounded in Analytical Chemistry particularly mass spectrometry (MS), Biophysics and Physiochemistry. Examples are analytical ultracentrifugation, dynamic light scanning, mass photometry, HPLC
  • Mentor and coach junior team members
  • Independently develop and review SOPs, work instructions, test records, and test reports
  • Design and execute, independently or as a Team, data-driven DOEs to support QbD assessment of assays, products, and processes.
  • Independently lead analytical method transfer from client to CMC Development and to QC
  • Independently analyze data, present results and conclusions to the team
  • Periodic client-facing role to walk through methodology and data analysis
  • Innovate within the Gene Therapy field to expand Process and Product knowledge
  • Responsible for some lab management tasks
  • Keep current on Environment, Health & Safety policies, ensure safe environmental and working conditions in the Analytical Sciences labs

Benefits

  • A choice of national medical and dental plans, and a national vision plan, including health incentive programs
  • Employee assistance and family support programs, including commuter benefits and tuition reimbursement
  • At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
  • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
  • Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
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