Drug Substance MSAT Scientist II

About the role

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Responsibilities

• Complete Technology Transfer activities by performing manufacturing process development for Injectables products to commercial lines.
• Establish formulation processes, product pathway and select components for successful scaleup using experimental design.
• Support client calls, prepare documentation (including but not limited to work orders, protocols, summaries) with minimum supervision, and provide scientific justification and update status of project work as needed.
• Technically support day-to-day operations in the drug substance formulation and downstream processes.
• 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 work orders for existing processes, FORMs, reports, memos, and protocols.
• Lead projects with a moderate level of supervision, implement change control actions, review and plan 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 and support interpretation and summary of data.

Requirements

• Bachelor’s of Science in Chemistry, Biochemistry, Biology, Pharmaceutical, Engineering or related physical science.
• Bachelor’s 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.

Environmental Conditions

• Able to lift 40 lbs. without assistance.
• Adherence to all Good Manufacturing Practices (GMP) Safety Standards.
• Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc. allowed.
• Laboratory Setting, Office.
• Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.).
• 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.
• Exciting company culture that stands for integrity, intensity, involvement, and innovation.
• 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, including 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.

Pay

The salary range estimated for this position based in Massachusetts is $66,000.00–$99,000.00. 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.