Drug Substance MSAT Scientist II

About the role

Technically supports day-to-day operations in the drug substance formulation, and Downstream processes. Works on technical/scientific process/product/project activities to implement strategies and technical solutions. Assists 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.

Responsibilities

• 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 work orders for existing processes, FORMs, reports, memos, and protocols.
• Lead 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).
• Collects data for statistical analysis. Can support interpretation and summary of data.

Requirements

• Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
• 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.

Qualifications

• Bachelor’s of Science in Chemistry, Biochemistry, Biology, Pharmaceutical, Engineering or related physical science.
• Bachelors and 2+ years of related experience, or, related Master’s degree.
• Experience in a CMO or Pharmaceutical product development field.

Skills

• Excellent knowledge of scientific methodology and development as related to the pharmaceutical industry.
• Prior experience in tech transfer or process validation.
• 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 salary range estimated for this position based in Massachusetts is $66,000.00–$99,000.00.

Schedule

Standard (Mon-Fri)