Principal Scientist, Technical Services

Use Your Power for Purpose

This individual will be a key part of the McPherson Technical Services Group responsible for delivering science-based solutions on a day to day basis. The primary function of the Technical Services Principal Scientist is the application of advanced manufacturing, science and technology processes to a given production segment by serving as a scientific and technical representative who champions process improvements and knowledge management excellence at the site to identify and implement process improvements in conjunction with manufacturing operations. Emphasis on process improvements shall include building quality into processes during the Technology Transfer process, improving process robustness for new product launch and launch process. This position will provide technical leadership and function as a site subject matter expert for Technology Transfer.  This includes the transfer of existing products to alternate manufacturing lines and new products to the site. This requires comprehensive knowledge of Pharmaceutical Sciences and applying these skills as the technical resource. Knowledge of product manufacturing processes including raw materials, container closure systems and devices. This position will identify and evaluate new and innovative technology, identify, and develop improved processes for new and existing products and drive critical investigations. This requires comprehensive knowledge of Pharmaceutical Science and good understanding of others and applies these skills as the technical resource. The responsibilities include but are not limited to authoring technical protocols and reports, extractable/leachable studies, process development and qualifications, technical and scientific support for critical investigations and leading continuous improvement initiatives.

What You Will Achieve

Role Responsibilities:

• Serves as the scientific/technical representative for process-related issues at the site, participate in investigation resolution using green belt/black belt tools, process validation activities, training on new process technologies and on significant changes to manufacturing procedures
• Proposes process improvement opportunities and/or corrective actions to increase yield, maximize capacity, reduce costs, decrease process variability while maintaining regulatory compliance.
• Identifies and executes on process improvements, creates data packages by justifying and outlining recommendations for changes to or improvements in production processes and collaborates with technical staff to implement process technology initiatives.
• Executes technology transfers of products in collaboration with cross-functional SME  team, partnering with manufacturing to meet production schedules, ensure commercial supply and uphold quality standards.
• Champion all PGS knowledge management efforts and help develop a strong culture of knowledge management excellence at the site.
• Deliver Excellence in all aspects of product/process knowledge management at the site to improve robustness of manufacturing processes.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience

• Understanding of FDA and Global regulations and guidelines for the analytical testing requirements and methods used in the qualification and validation of parenteral drug products and associated container closure systems.

• Experience with authoring protocols, technical reports, method development and validation.

• Must possess excellent communication skills and attention to details.

• Demonstrated problem solving capabilities.

• Ability to get tasks accomplished and manage priorities while working in high pressure situations with aggressive time constraints.

• Competency in PC software much as MS Word, Excel and Project

Bonus Points If You Have (Preferred Requirements)

• Relevant experience in Engineering or Science within the pharmacutical industry.
• Manufacturing experience related to global regulations on devices, drugs and validation requirements.
• Knowledge of extractables/leachables method development and qualification.
• Experienced with leading cross functional teams in technical project execution, investigations, and issue resolution.
• Experience in the management of complex investigations w