MS&T Scientist At Argenta, we're more than a company — we're a global team, dedicated to healthier animals. We believe that when their lives are made better, we're all the better for it. Founded in 2006, we support companies big and small to develop and manufacture health products for pets and livestock. Our trusted, innovative solutions and services cover every stage of the process, from molecule to market. We're in a unique position. We are the world's only combined contract research and contract development and manufacturing organization (CRO/CDMO) dedicated to animal health. Our uniqueness means: We are team players; We are doers; We are customer-centric; We are innovators. We value diversity, as a global company, we get the richness of working with different people in different places whether it be location, stages of their career, their development, their role. We believe that when everyone works together and puts their best "paw" forward we will make the lives of the animals we care for, better. With bases in New Zealand, the US, the UK and Europe, our 900+ colleagues are driven by our partnership approach and purpose: Healthy Animals. Let's Make It Happen, Together. TEAM PLAYERS who want to DO great work and find INNOVATIVE ways to make animals lives better through our CUSTOMER CENTRIC efforts should apply. Argenta is currently looking to fill the role of MS&T Scientist at our Shawnee, KS location. 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.
Key Accountabilities:
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. Manages and controls 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. Understands the product and process complexity and supports Validation and Quality in establishing the testing/characterization requirements for various process steps and overall manufacturing process validation. Serve as single point of contact for internal teams and external customers as transfer lead for all technology and product transfers. Provide proper levels of customer service and act as key interface with customers as needed. 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.
Qualifications:
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.
Experience in leading technical cross-functional teams or relevant technical project management experience is highly desirable.
Strong communication skills and computer literacy are mandatory.
Experience with operational excellence, statistical analysis and ongoing process verification is desirable.
Must be able to effectively interact with senior executives, senior technical managers, and external customers.
