MS&T Scientist Job at Argenta (Shawnee)

Job Description

The MS&T Scientist provides subject matter expertise for leading and managing activities including product/technology transfers, innovation, and process optimization for pharmaceutical products for Oral Solid Dose, Soft Chewable Tablets, Non-sterile liquids or Injectable technology platforms. In addition to the technical expertise, this position will lead teams that support these transfers. As a technical project lead, the position will provide general oversight of technical communications, evaluations, timelines and requirements with internal teams and external clients.

Job Responsibility

Support/Lead product/technology transfers, process development, product maintenance activities establishing and optimizing commercial manufacturing processes for compounding and filling of solids, soft chewable tablets, non-sterile liquids and sterile injectable (aseptic manufacturing) platforms working closely with Manufacturing, Engineering, and Quality organizations
Generate technical protocols, reports, manufacturing documents and author Quality risk assessments to detect quality and technological risks
Lead development/engineering studies and batches
Manage and control the development of each project's work scope and schedules required for the support of key product integrations, ensuring they are completed on budget, on schedule, and technically correct
Identify critical quality attributes and the strategy for defining acceptable ranges for process parameters
Serve as single point of contact for internal teams and external customers as transfer lead for all technology and product transfers
Lead assessments regarding timelines, technical viability, resources, financial, investments, and communications needed to support product transfer activities
Support MFG efficiency and operations projects by interfacing with all internal departments (Quality, Engineering, Validation, Manufacturing, Planning, Supply Chain)
Ability to analyze and troubleshoot problems to effectively direct the activities of a cross-functional project team

Requirements

Bachelor's degree in Industrial Pharmacy, Pharmaceutics, Chemical Engineering or related scientific field
4+ years of industry experience in technology/product transfers and process optimization in a GMP environment or 2 years of industry experience with a Masters
Familiarity with processing equipment and technologies utilized in pharmaceutical GMP manufacturing facilities for solid dose, soft chewable tablets, non-sterile liquids and injectable platforms (at least in 2 areas) and sufficient experience in a commercial GMP environment
Experience in product/technology transfer activities and ability to author technical documents in support of all activities
Strong communication skills and computer literacy
Must be able to effectively interact with senior executives, senior technical managers, and external customers

Nice to have

Experience in leading technical cross-functional teams or relevant technical project management experience
Experience with operational excellence, statistical analysis and ongoing process verification

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MS&T Scientist

Job Description

Job Responsibility

Requirements

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