Scientist I, Upstream Process Development
Thermo Fisher Scientific

Job Description

Scientist I, Upstream Process Development (Viral Vector Services)

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.

Location / Division / Shift

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

How will you make an impact?

As a Process Development Scientist I, 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 Upstream Process Development team, you will have the opportunity to learn to operate cutting-edge instruments and perform activities spanning the full cell line and cell culture 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?

• Help design and conduct experiments for development activities.
• Complete experimental protocols / work instructions accurately and with limited supervision.
• Record results in notebook accurately, clearly, and regularly.
• Prepare experiments/data for presentation.
• Present process development data and project updates.
• Prepare and modify documents (development plans, batch records, SOPs, protocols, summary reports), including deviation and/or investigational reports.
• Participate in the development and/or optimization and implementation of new processes in the PD laboratory.
• Actively participate in laboratory instrumentation and equipment preventative maintenance and qualification programs.
• Demonstrate a strong focus on continuous improvement.
• Support technical transfer activities and help to identify workflow, resource, or process gaps.
• Support the sourcing of cGMP compatible raw materials for processes.
• Assist in the sourcing, purchase, installation, startup and calibration and maintenance of Process Development equipment.
• Provide subject matter expertise for equipment and processes within functional responsibility and assist in the equipment/process transfer to cGMP manufacturing.
• Complete improvement projects identified.
• Work with process development teams to solve process challenges.

How will you get there?

• Bachelor's Degree in biology, chemistry, biochemistry, chemical engineering, biomedical engineering, or a related field. Master's preferred with relevant coursework or industry experience.
• 1+ years' experience in a process development / manufacturing environment preferred.
• Industry experience in aseptic technique, cell culture, single-use bioreactors (SUBs), wave reactors preferred.
• Demonstrated knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biological industries is preferred.
• Knowledge of gene therapy product and/or process development preferred.
• Excellent problem solving and critical thinking skills, including strong attention to detail.
• Ability to analyze and summarize complex scientific data.
• Excellent organization, planning, and time management skills.
• Self-motivated, willing to learn, independent and a proactive driving force of efficient execution.
• Strong interpersonal and communications skills (written and oral).
• Able to work effectively with a wide range of constituencies in a diverse environment.
• Good comprehension of Microsoft Office Suite software.

While performing the duties of this job, the employee:

• Will be expected to function in a dynamic environment and balance multiple priorities simultaneously.
• Will be expected to learn new software and tools quickly.
• Will use highly specialized equipment and instrumentation in daily manufacturing.
• Will proactively identify areas for opportunity and drive efficiency results.
• Will critically review processes and provide input 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.

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