Job Title: Scientist II, Process Development Downstream

Req #: 229291BR

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, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them.

Location/Division Specific Information

Plainville, MA | Drug Substance Division

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 groundbreaking Cell and Gene Therapy business, our mission is to enable clients to cure genetic, rare, and otherwise untreatable diseases.

Discover Impactful Work

As the Downstream Process Development Scientist you will help our clients to deliver lifesaving and life changing therapies to patients in need. In the process development group we are responsible for process characterization, scale up and late stage process development. You will be responsible for planning, executing, and documenting laboratory and tech transfer activities in support of process establishment, pilot, and transfer into cGMP manufacturing. You will also act as a subject matter expert (SME) and support a detailed transfer and operation of internally developed and client transferred processes into the process development and pilot space. You will also be supporting tech transfer out to the cGMP manufacturing space. The Downstream Process Development Lead position will be responsible for the design of experimental studies and lead all aspects of the execution with members of the larger team.

A Day in the Life:

• Contribute to multiple projects and participate in the planning and execution of process development and scale up activities (both bench and pilot scale)
• Serve as functional SME and work collaboratively with other team members on all aspects of downstream execution for viral vector processes
• Participate and/or lead the training and development of other team members
• Prepare and modify documents (development plans, batch records, SOPs, protocols, summary reports)
• Identify technical gaps/facility fit challenges for new clients/processes
• Support analytical testing for process development and characterization
• Lead Practical Process Improvement (PPI) initiatives

Keys to Success

Education

• B.S. in Chemical Engineering, Biochemistry, Biology or related field with 3+ yrs, of experience
• Master’s degree

Experience

• Design and execution of downstream unit operations
• Understand experimental design and be able to independently complete laboratory experiments
• Strong hands-on experience with different purification techniques such as affinity and anion exchange chromatography and associated instrumentation such as AKTA chromatography systems and Unicorn software
• Experience with depth filtration design and sizing including manifold assemblies
• Design and execute DOE studies & high-throughput screening for purification process improvements including parameter optimization, scale-up, and buffer selection
• Viral reduction filtration and support for viral clearance studies
• Has completed tangential flow filtration along with final formulation for virus, and plasmid DNA-based gene therapies
• Scale-up of downstream processes, supports process characterization and validation activities
• Effective problem solving and troubleshooting abilities
• Collaborating with Upstream and Analytical Testing/Development teams to build process understanding and design and execution of in-process testing and control assays

Knowledge, Skills, Abilities

• Working level knowledge of downstream purification of mammalian and insect cell culture processes
• Experience in scale up and scale down of purification processes
• Ability to analyze and summarize scientific data
• Understanding of cGMP and regulatory requirements of biopharmaceutical manufacturing
• Strong interpersonal and communications skills; written and oral
• Ability to function in a constantly evolving environment & handle multiple priorities
• A flexible work schedule is required including Weekend and night as needed to support lab activities.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.