Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
DESCRIPTION:
As an Upstream Process Development 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, 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 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. Manage project timelines and tasks.
Technically review data, collaborate with customers on data and experimental design, prepare documents and experiments, participate in investigations.
Serve as a SME 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+ years9 experience in a process development/manufacturing environment, Master7s with 2+ years of experience or Ph.D.
- Expertise in gene therapy product and/or process development is required. Knowledge of lentivirus upstream process 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 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 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.
Compensation and Benefits
The salary range estimated for this position based in Massachusetts is $91,700.00 $137,525.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
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
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
