IDAP TS/MS Representative

Role Summary

The Technical Services and Manufacturing Sciences (TS/MS) Representative is a technical position that supports, develops and implements a technical agenda for their area of responsibility. The TS/MS Representative is responsible for providing technical leadership for activities within Indianapolis Device Assembly & Packaging (IDAP), including new product commercialization and commercial product support. Primary objectives include reliable and compliant manufacturing of products, continuous improvement of processes, and supporting day-to-day operations of process teams.

Responsibilities

• Execute the overall technical agenda for the IDAP site.
• Provide technical support to non-routine (e.g., deviation, complaint) investigations, including consultation on quality and stability issues acting as product expert.
• Prepare, review, and approve, as required, relevant technical documents such as: annual product reviews, change controls, regulatory submissions, deviations, validations, procedures, PFDs, PFMEAs, etc.
• Lead technical projects to improve process control and/or productivity.
• Drive technical consistency across process teams.
• Serve as interface with upstream suppliers, and global device / drug product networks.
• Own batch records and revisions, ensuring they are current and accurate.
• Facilitate equipment commissioning and qualification activities, as required
• Collaborate with Commercialization Project Manager as well as cross-functional tech transfer team members to commercialize new products in IDAP
• Understand the scientific principles required for Device Assembly and Packaging operations
• Support regulatory submissions as needed
• Understand and implement global requirements and standards into Process Teams.
• Own and maintain structure and content for electronic batch tickets.
• Monitor process control and capability.
• Provide off hours support as needed to process team

Qualifications

• Required: Bachelor’s degree or equivalent in a STEM discipline
• Required: Technical / Scientific knowledge
• Required: Clear understanding of cGMPs
• Preferred: Good written and oral communications
• Preferred: Good teamwork and interpersonal skills
• Preferred: Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals

Skills

• Technical writing and documentation
• Cross-functional collaboration
• Process improvement and problem-solving
• Quality systems and regulatory awareness
• Communication and interpersonal skills

Education

• Bachelor’s degree in a STEM discipline (required)