The Technical Services Principal Scientist will be responsible for applying advanced manufacturing, science, and technology processes to a specific production segment, championing process improvements and knowledge management excellence. They will serve as a subject matter expert for technology transfer, identifying and implementing process improvements, and driving critical investigations. This role requires expertise in pharmaceutical sciences and a strong understanding of manufacturing processes.

Key Responsibilities:

• Serve as a scientific/technical representative for process-related issues, participating in investigation resolution, process validation activities, and training on new process technologies.
• Propose process improvement opportunities and corrective actions to increase yield, capacity, and cost-effectiveness while maintaining regulatory compliance.
• Identify and execute process improvements, create data packages, and collaborate with technical staff to implement process technology initiatives.
• Execute technology transfers of products in collaboration with manufacturing, ensuring production schedules and quality standards are met.
• Champion knowledge management efforts and foster a culture of knowledge management excellence.
• Improve the robustness of manufacturing processes by delivering excellence in product/process knowledge management.

Must-Have Skills:

• BS degree with 5 years experience, or MS degree with 3 years experience, or PhD with no experience.
• Understanding of FDA and global regulations and guidelines for analytical testing.
• Experience authoring protocols, technical reports, and method development/validation.
• Excellent communication skills and attention to detail.
• Strong problem-solving capabilities.
• Ability to manage priorities and tasks in high-pressure situations with tight deadlines.

• Relevant experience in Engineering or Science within the pharmaceutical 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 with analysis of data utilizing statistical software (JMP, Minitab).
• Experienced project management skills with ability to meet agreed upon targets and plan development for short-term and long-term activities.
• Ability to think creatively and find innovative solutions is a plus.