Drug Product MSAT Scientist I

About the role

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Responsibilities

• 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), and provides scientific justification and update status of project work as needed.
• Technically supports day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant.
• Works on technical/scientific process/product/project activities to implement strategies and technical solutions.
• Aids 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.
• Makes decisions that involve direct application of technical knowledge.
• Completes studies, tech transfer, commercial scale-up and support process validation.
• Represents the organization on internal technical discussions.
• Participates in problem solving and project results for formulations, equipment and processes.
• Writes/revise FORMs, reports, memos, and protocols.
• Supports projects with a moderate level of supervision, implements change control actions, reviews and plans technical aspects of the project to meet timeline and project goals.
• Supports manufacturing operations, change controls, investigations as subject matter expert (SME).
• Collects data for statistical analysis. Can support interpretation and summary of data.

Requirements

• Bachelor’s 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.

Qualifications

• Excellent knowledge of scientific methodology and development as related to the pharmaceutical industry.
• Prior engineering experience in Fill line is preferred plus 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.

Skills

• Excellent knowledge of scientific methodology and development as related to the pharmaceutical industry.
• Prior engineering experience in Fill line is preferred plus 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.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.

Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects.

We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Pay

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

Schedule

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.