Sci I, Process Development

Thermo Fisher Scientific • Plainville, MA

2d • $28 - $36 • Onsite

About The Position

As the Upstream/Downstream Process Development Scientist you will help our clients to deliver lifesaving and life changing therapies to patients in need. You will be supporting 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 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.

Requirements

• B.S. in Chemical Engineering, Biochemistry, Biology or related field
• Demonstrated understanding of experimental design with the ability to independently conduct laboratory experiments.
• Proficiency in technical writing, adhering to Good Documentation Practices (GDP), with preferred experience in data compilation and interpretation.
• Strong communication skills with the ability to clearly and concisely interpret, summarize, and present scientific data.
• Flexibility in work hours, including availability for weekends and evenings, as the need arises to meet project timelines.
• 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 & balance multiple priorities.
• A flexible work schedule is required including Weekend and night as needed to support lab activities.

Nice To Haves

• Practical experience in aseptic techniques, cell culture, single-use bioreactors (SUBs), wave reactors, and harvest/clarification processes is preferred.
• Familiarity with transfection and infection -based processes for gene therapy production
• Expertise in various purification techniques, including affinity and anion exchange chromatography, with proficiency in using AKTA chromatography systems and Unicorn software is helpful.
• Experience with filtration-based unit operations such as tangential flow filtration, sterile filtration, and depth filtration is helpful.

Responsibilities

• Supporting planning, executing, and documenting laboratory and tech transfer activities in support of process establishment, pilot, and transfer into cGMP manufacturing.
• Act as a subject matter expert (SME) and support transfer and operation of internally developed and client-transferred processes into the process development and pilot space.
• Supporting tech transfer out to the cGMP manufacturing space.
• Collaborate with the Analytical Development team to develop comprehensive testing plans.
• Participate in client meetings to present results and assist with drafting process development reports.
• Prepare Process Development records, work instructions, and batch records.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level