Scientist I

Job Description

Job Summary: 

• 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 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.

Duties and 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 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).
• Collects data for statistical analysis.
• Can support interpretation and summary of data.

Knowledge, Skills, and 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.

Physical Requirements:

• 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.