Sci III - Upstream Process Development

Work Schedule

Environmental Conditions

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science with annual revenue exceeding $35 billion. Whether our customers are accelerating life sciences research solving sophisticated analytical challenges or improving patient diagnostics and therapies we are here to support them.

When you join our team youll 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 youll be supported in achieving your career goals. Youll also have the opportunity for continual growth and learning in an environment that will support your development.

We are seeking an upbeat and hardworking individual with strong communication leadership technical and operational skills to join our growing team at Viral Vector Services (VVS).

Job Title: Sci III - Upstream Process Development

Location/Division Specific Information: 5 Commerce BoulevardPlainville MA Onsite

How will you make an impact

As a Scientist III you will help our clients to deliver lifesaving therapies to patients. This position will provide direct labor within multiple work centers and will provide indirect support for projects/troubleshooting maintenance engineering and/or training initiatives.

This is a hands-on bench scientist position. The ideal candidate shall have excellent lab skills strong documentation skills proven track record 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 design 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. Lead project timelines and tasks.

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

• Serve as an expert in process development and train junior scientists.

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 Masters with 2 years of experience or Ph.D
• Expertise in gene therapy product and/or process development is required. Knowledge of lentivirus development is strongly preferred.
• Hands-on experience in aseptic technique cell culture stirred tank bioreactor wave reactors and harvest/clarification operations.
• Experience in technical writing GDP compliance and data compilation/analyses.

• Strong digital literacy as well as ability to collect analyze interpret and summarize sophisticated scientific 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 by design (QbD) and regulatory needs in the pharmaceutical industry
• 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.