Sr. Principal Scientist - TS​/MS Device & Packaging

Key Responsibilities

Provide technical oversight and deliver successful approaches for new and existing medicines introduced on lines, support technical transfer, and optimize existing control and capacity to maintain reliable supply across the site.

• Demonstrate a strong ownership and stewardship for medical device design, manufacturing, labeling, and/or packaging processes.
• Liaise with regulatory function to align on strategies for new products, packaging, platform changes and planning for consolidated technical change agendas.
• Engage externally to ensure the organization stays current in evolving risk management, technology, regulatory and compliance environment.
• Prepare, review, and approve study designs, protocols, technical reports, and other related technical documentation.
• Independently identify key engineering questions/issues and develop solutions to advance business objectives.
• Provide technical and effective process support services for production issue resolution and investigation with proficient data analysis and first principles applications.
• Identify and drive improvement opportunities; implement technology transfer agenda ensuring seamless integration and replication of Site business and Quality Systems for Commercial Launch/Technical Agenda activities.
• Support complex investigation of key issues and events and work on identification and implementation of CAPA plans.

• Bachelor’s degree in Science, Engineering, or related field.
• 5+ years of experience in pharmaceutical and/or medical device manufacturing or regulated industry.
• Strong understanding of cGMPs and pharmaceutical or regulated industry manufacturing.
• Ability to lead complex technical projects and make informed decisions.
• Prior experience in packaging and/or device assembling operations.
• Familiarity with Commercialization process and Process Control requirements.
• Demonstrated strong technical leadership and communication skills.
• Ability to work well independently and in teams; provide partnership and collaboration across multiple disciplines.
• Demonstrated strong analytical and problem‑solving abilities.
• Project management experience and basic statistical skills.
• Working knowledge of equipment and facility qualification processes.
• Safety equipment (PPE) and precautions required in the manufacturing plant environment.
• Variable travel may be required to support business needs, 0‑50%.

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$114,000 - $198,000