The Research Scientist will initially focus on the delivery of parenteral operations, specifically regarding technical transfer and process validation. The Senior Scientitst will support one of either formulation, filling, or visual inspection (VI), although may support multiple areas during start-up phase. Upon the start of commercial production, this role's objectives include maintaining the validated state of applicable processes, establishing and monitoring metrics/methods to ensure a state of capability and control, harmonization of control strategies across process teams, evaluate process improvement, and serving as an escalation point for day-to-day operations issues.

Key Objectives/Deliverables:

• Lead risk management activities as it pertains to product/process.
• Provide technical support to non-routine (e.g., deviation, complaint) investigations, including consultation on quality and stability issues
• Prepare and Review or approve, as required, relevant technical documents such as: Annual Product Reviews, Change Controls, Regulatory Submissions, Deviations, Validations, Procedures, PFDs, PFMEAs, etc.
• Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability.
• Identify opportunities and lead technical projects to improve process control and/or productivity
• Serve as interface with upstream suppliers and parenteral product networks
• Provide Audit support as needed.
• Identify opportunities and participate in projects to improve process control and/or productivity.

Basic Qualifications:

• Bachelor's degree or higher an engineering, packaging science, or related field
• 2+ years experience in cGMP manufacturing (validation, engineering, TSMS, operations, QA, etc.)

Additional Skills/Preferences:

• Pharmaceutical and/or medical device manufacturing experience
• Proficiency with computer systems including Microsoft Office products, Veeva Vault, TrackWise, electronic batch records, and SAP
• Demonstrated successful leadership of cross-functional teams
• Strong interpersonal and teamwork skills
• Strong self-management and organizational skills