Scientist III, Upstream Process Development
Thermo Fisher Scientific

Job Info

---

Work Schedule
Other

Environmental Conditions
Office

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 Process Development team.

At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading- and innovative Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.
• Location: 5 Commerce Boulevard Plainville, MA - Onsite

How will you make an impact? As a Process Development Scientist III, you will help our clients to deliver lifesaving and life changing therapies to patients in need. This position will provide direct labor within multiple work centers and will provide indirect support for projects/troubleshooting, maintenance, engineering and/or training initiatives.

As a member of the Process Development team, you will have the opportunity to learn to operate cutting-edge instruments and perform activities spanning the full range of the viral vector production process. This is a hands-on bench scientist position. The ideal candidate shall have excellent lab skills, strong documentation skills, demonstrated ability to analyze and interpret data to draw conclusions and make recommendations, and strong collaboration and teamwork skills.

As a member of the Process Development team, you will work with project leads to support the successful execution of experiments and technical transfer activities. This will include supporting the technical transfer process assessments, Pilot Plant activities and transfer into cGMP manufacturing. This will also include late-phase process characterization of viral vector manufacturing processes.

What will you do?

• Participate in the planning and execution of tech transfer, process development and scale up activities (both bench and pilot scale) and preparing summary reports/presentations.

• Prepare and modify documents (development plans, batch records, SOPs, protocols, summary reports), including deviation and/or investigational reports.

• Serve as project lead on multiple programs with minimal direction. Manage project timelines and tasks.

• Make project level decision on process development items including critical investigations and process improvement/optimization.

• Design and conduct experiments for process development or optimization, applying proven understanding in process technologies and scale-up principles.

• Support tech transfer activities and help to identify workflow, resource, or process gaps.

• Support raw materials/consumable sourcing for process and analytical development activities.

• Technically review data, collaborate with customers on data and experimental design, prepare documents and experiments, participate in investigations.

• Identify and implement various efficiency improvements for processes and equipment.

• Working closely with Manufacturing and Manufacturing Sciences to share a point of view for equipment and processes within functional responsibility and assist in the equipment/process transfer to cGMP Manufacturing.

• Assist in preparing detailed process development report to support manufacturing and regulatory requirements.

• Support sourcing, purchase, installation, startup and calibration and maintenance of Process Development equipment.

• Serve as a SME in process development and train junior scientists.
• Support analytical testing for process characterization.

How will you get there?

• Degree in biology, chemistry, biochemistry, (bio)chemical engineering, biomedical engineering, or a related field.

• B.S with 5+ years' experience in a process development/manufacturing environment, Master's with 2+ years of experience or Ph.D.

• Hands-on experience in aseptic technique, cell culture, single-use bioreactors (SUBs), wave reactors and harvest/clarification.

• Proven ability for technical proficiency, scientific creativity, problem solving skills, critical thinking and collaboration with other departments.

• Experience in technical writing, GDP compliance, data compilation and interpretation preferred.

• Strong computer skills as well as ability to collect, organize, analyze, interpret and summarize complex scientific data.

• Strong written and verbal communications skills; ability to interpret, summarize, and present scientific results in a clear, concise, accurate manner.

• Must be a self-starter, have excellent time management, planning and organization skills.

• Good knowledge of quality and regulatory needs in the pharmaceutical industry, knowledge of gene therapy product and/or process development preferred.

• A flexible work schedule may be required, including weekends and evenings as needed to complete client work.

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.

---