Drug Product MSAT Scientist II

Job Description In this role, you will 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 scale-up. 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. Key Responsibilities 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, and 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. Makes decisions that involve direct application of technical knowledge. Day in the Life 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. Collect data for statistical analysis and support interpretation and summary of data. Education Bachelor’s of Science in Chemistry, Biochemistry, Biology, Pharmaceutical, Engineering or related physical science. Experience Bachelor’s degree and 2+ years of related experience, or a related Master’s degree. Experience in a CMO or Pharmaceutical product development field. Knowledge, Skills, Abilities 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. Physical Requirements 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. Office environment. Some degree of PPE required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Work Schedule Standard (Mon‑Fri) Benefits 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. We offer a comprehensive Total Rewards package that includes: 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 our competitive 401(k) U.S. retirement savings plan Employee Stock Purchase Plan (ESPP) offering eligible colleagues the opportunity to purchase company stock at a discount EEO Statement 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. Relocation assistance is not provided. #J-18808-Ljbffr Dormont Manufacturing Co