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Drug Product MSAT Scientist I

Thermo Fisher Scientific · Plainville, MA · 1 mo ago
On-siteProduct$25.6–$38.39/hrFull-time

About the role

Complete Technology Transfer activities by performing manufacturing process development for Injectables products to commercial lines. Using experimental design, establish formulation processes, product pathway and select components for successful scaleup. Support client calls, prepare documentation (including but not limited to work orders, protocols, summaries, with minimum supervision), and provides scientific justification and update status of project work as needed.

Responsibilities

  • Technically support day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant
  • Work on technical/scientific process/product/project activities to implement strategies and technical solutions
  • Assist in the creation of processes, single use systems, and equipment designs for clinical, scale up, and/or registration batches, including technology transfer of projects from clients
  • Make decisions that involve direct application of technical knowledge
  • Complete studies, tech transfer, commercial scale-up and support process validation
  • Represent the organization on internal technical discussions
  • Actively participate in problem solving and project results for formulations, equipment and processes
  • Write/revise FORMs, reports, memos, and protocols
  • Support projects with a moderate level of supervision, implement change control actions, review and plans technical aspects of the project to meet timeline and project goals
  • Support manufacturing operations, change controls, investigations as subject matter expert (SME)
  • Collect data for statistical analysis; support interpretation and summary of data

Qualifications

  • Bachelor of Science in Chemistry, Biochemistry, Biology, Pharmaceutical, Engineering or related physical science
  • Bachelors and 1+ years of related experience, or related Master's degree
  • Experience in a CDMO or Pharmaceutical product development field is preferred

Skills

  • Excellent knowledge of scientific methodology and development as related to the pharmaceutical industry
  • Prior engineering experience in Fill line is preferred
  • Detailed knowledge of Good Manufacturing Practices
  • Effective written, interpersonal, and presentation skills, including running technical discussions with internal and external clients
  • Ability to work on multiple projects simultaneously
  • Ability to acquire knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures
  • Ability to keep current with scientific literature and industry trends relating to process technologies
  • Ability to run technical solutions
  • Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand and walk; ability to lift and/or carry light objects of up to 25 lbs. for brief periods

Benefits

  • Competitive remuneration and annual incentive plan bonus
  • Healthcare and a range of employee benefits
  • 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 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

Pay

Hourly pay range estimated for this position based in Massachusetts is $25.60–$38.39. 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.

Schedule

Standard (Mon-Fri)

Work setting includes laboratory, office, and warehouse environments with adherence to all Good Manufacturing Practices (GMP) Safety Standards. Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.). Relocation assistance is not provided. Must be legally authorized to work in the United States now and in the future, without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening.

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