Manufacturing Scientist II (Technology Transfer)

About the position

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.

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/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.
• 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

• 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.
• Excellent knowledge of scientific methodology and development as related to the pharmaceutical industry.
• Detailed knowledge of Good Manufacturing Practices.
• Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
• Excellent critical and logical thinking skills.
• 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.

Nice-to-haves

• Experience in a CMO or Pharmaceutical product development field PREFERRED.
• Equivalent combinations of education, training, and meaningful work experience may be considered.