Sr Engineer III, Manufacturing Sciences

Role Summary

As a Sr. Engineer III in Manufacturing Sciences, you will lead and coordinate biologic molecule technology transfer activities at the RTP site. You will create and drive technology transfer deliverables, manage schedules and metrics, and provide technical leadership and strategic direction. You will communicate transfer plans and risk mitigations to senior leadership and align activity with departmental priorities. This role supports internal programs and strategic partners to enhance business value.

Responsibilities

• Coordinate and lead tech transfer meetings, ensuring effective information flow and decision-making.
• Manage activities related to tech transfer, including process/facility fit, manufacturing readiness, and project closeout.
• Analyze complex technical data related to the development and transfer of biologic molecules.
• Communicate tech transfer updates, risks, and mitigations to multiple levels of leadership.
• Ensure adherence to the tech transfer business process, including risk tracking and audit support.
• Coordinate reports and data to support CAPAs, deviations, and long-range business decisions.
• Provide technical expertise in biopharmaceutical manufacturing and process development.
• Support programs as an upstream or downstream SME as needed.
• Support junior staff development and complex transfer issues.

Qualifications

• Required: Bachelor's degree in Engineering or relevant scientific/technical discipline with a minimum of 8 years of relevant experience.
• Required: Master's degree in Engineering or relevant scientific/technical discipline with a minimum of 6 years of direct experience.
• Required: Ph.D. in Engineering or relevant scientific/technical discipline with a minimum of 4 years of direct experience.
• Required: Strong foundation in upstream or downstream biologics manufacturing or process development.
• Required: Experience with Good Manufacturing Practices.
• Required: Ability to communicate and escalate solutions effectively.
• Required: Proven leadership skills in managing cross-functional teams.
• Preferred: Experience with process validation and regulatory submissions.
• Preferred: Ability to serve as the primary technical point of contact with strategic partners.