Senior Manager, MSAT Sterile Ops Technical Team

Position Summary & Responsibilities

This position will provide direction, leadership, and technical guidance to a team of MSAT Specialists responsible for tech transfer and implementation of fully qualified new processes, capabilities, and equipment in a cGMP environment.

• Lead the MSAT Technical team with focus on people management and coaching to develop and maintain a high performing, diverse organization.
• Own the development and maintenance of standards and best practices for site Tech Transfer activities to assure fully validated and compliant processes are implemented in manufacturing.
• Accountable for site technical support for the entire Tech Transfer process from initial evaluation to PPQ in compliance with site procedures and regulatory guidance.
• Assure justification is documented for key technical decisions in a GMP manner and is supported by risk management, data, and strong scientific principles.
• Maintain strong focus on lean ways of working and foster a culture of continuous improvement.
• Maintain a strong relationship with PMO, Validation, Quality, and Operations Stakeholders.
• Maintain external technical relationships and collaborate with equipment and material suppliers.
• Maintain a high level of expertise and awareness of the latest trends in technology through review of relevant scientific literature and guidelines.
• Make recommendations and develop business cases for new opportunities and technologies for the company to pursue.
• Effectively present technical data in an understandable fashion to site and corporate leadership.
• Perform work requirements in a responsible manner in accordance with SOPs, cGMPs and safety procedures in accordance with OSHA requirements and company EHS guidelines.
• Contribute to the development of group and site culture by exercising creativity in dealing with new challenges encountered within an evolving organization.
• Take an active role in finding solutions and improvements for the facility.
• Work independently under direction from the site MSAT Lead.

Minimum Qualifications

• Extensive experience in aseptic operations, formulation, aseptic Filling, visual inspection, device assembly, and/or packaging in a regulated environment.
• Strong leadership capabilities, including ability to influence globally and work in a team environment, providing coaching with strong communication skills.
• Experience with Technology Transfer in a GMP environment.
• Proven ability to work effectively in a team environment.

Preferred Qualifications

• Bachelor’s degree in engineering or a related discipline.
• Ability to generate and interpret technical documents.
• Experience managing external technical relationships.
• Training in, or awareness of, lean six sigma and lean manufacturing.