Scientist I Upstream and Downstream Process Development

ThermoFisher Scientific; Plainville (MA); On-site; USD 39,000 - 58,000; Full time

Benefits offered by this job

PTO 120 hours

Paid holidays

Parental leave

Disability insurance

401(k) plan

ESPP

Tuition reimbursement

Commuter benefits

Job summary

Thermo Fisher Scientific Inc. is a world leader in serving science with extensive resources for gene therapy process development.

The Upstream/Downstream Process Development Scientist will support planning, execution and documentation of lab and tech transfer activities, enabling process establishment, pilot runs and transfers into cGMP manufacturing. You will act as an SME and assist with transfer and operation of internally developed and client-transferred processes into development and pilot

Qualifications

• Understanding of experimental design and ability to independently conduct lab experiments.
• Experience with analytical development and data interpretation.
• Proficient technical writing following GDP and able to draft process development records.

Responsibilities

• Support planning, execution and documentation of lab and tech transfer activities.
• Assist transfer of processes into cGMP manufacturing space.
• Contribute to development of process establishment, pilot and transfer workflows.

Skills

Experimental design

Lab techniques

Data interpretation

Scientific writing

Team collaboration

Education

B.S. in Chemical Engineering, Biochemistry, Biology or related field

Tools

AKTA

Unicorn

TFF

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift

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 complex analytical challenges, improving patient diagnostics and therapies or increasing efficiency in their laboratories, we are here to support them.

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 to help clients deliver innovative gene therapies.

How will you make an impact?

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.

Education regiments:

B.S. in Chemical Engineering, Biochemistry, Biology or related field

General qualifications:

• 0-2 years of related experience


• Demonstrated understanding of experimental design with the ability to independently conduct laboratory experiments.


• 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.


• 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.

Upstream Process Development Qualifications:

• 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

Downstream Process Development Qualifications:

• 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.

Knowledge, Skills, Abilities

• 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.

Compensation and Benefits

The hourly pay range estimated for this position based in Massachusetts is $28.16–$42.24.

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

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.