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Jobs · Engineering · Massachusetts

Scientist I Process Development - Upstream or Downstream

Thermo Fisher Scientific · Plainville, MA · 2 mo ago
On-siteEngineering$28.16–$42.24/hrFull-time

US - Massachusetts – Plainville (on-site)

About the role

As the Upstream/Downstream Process Development Scientist you will help our clients deliver lifesaving and life-changing therapies to patients in need. You will support planning, executing, and documenting laboratory and tech transfer activities in support of process establishment, pilot, and transfer into cGMP manufacturing. You will 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, as well as tech transfer out to the cGMP manufacturing space.

Responsibilities

  • 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.
  • Conduct laboratory experiments independently with demonstrated understanding of experimental design.
  • Adhere to Good Documentation Practices (GDP) and proficiency in technical writing, including data compilation and interpretation.
  • Clearly and concisely interpret, summarize, and present scientific data.
  • Flexibility in work hours, including availability for weekends and evenings, as needed to meet project timelines.

Requirements

  • B.S. in Chemical Engineering, Biochemistry, Biology, or related field.
  • Demonstrated understanding of cGMP and regulatory requirements of biopharmaceutical manufacturing.
  • Strong interpersonal, written, and oral communication skills.
  • Ability to function in a constantly evolving environment and balance multiple priorities.
  • Flexible work schedule, including weekends and nights as needed to support lab activities.

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.

Environmental Conditions

  • Laboratory setting
  • Office
  • Standing for full shift

Schedule

Standard (Mon-Fri)

Pay

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.

Benefits

  • A choice of national medical, dental, and vision plans, 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 a 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.

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