MS&T Transfer Manager - Pharma

MS&T Transfer Manager  - Pharma (West Chester, OH)

Our client, a  biopharmaceutical CDMO, is currently hiring a Sr. Manager for their Sterile Ops Technical Team. This role is the leader of the MSAT (Manufacturing Science & Technology) team responsible for bringing new pharmaceutical products, processes, and equipment into a manufacturing facility. They will manage a team of technical specialists who support technology transfers, validation, and process implementation in a GMP environment.

The person will make sure new manufacturing processes are successfully transferred from development into production, meet regulatory requirements, and are ready for commercial manufacturing.  This is a senior MSAT leadership role that oversees the people and technical strategy needed to launch new drug manufacturing processes, improve existing operations, and ensure everything is compliant, efficient, and ready for production.

Role is the leader of the MSAT (Manufacturing Science & Technology) team responsible for bringing new pharmaceutical products, processes, and equipment into a manufacturing facility. They manage a team of technical specialists who support technology transfers, validation, and process implementation in a GMP environment.

The person will make sure new manufacturing processes are successfully transferred from development into production, meet regulatory requirements, and are ready for commercial manufacturing. They will work closely with Quality, Validation, Operations, and Project Management while driving process improvements, solving technical challenges, and developing best practices.

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.

Client is a biopharmaceutical CDMO (Contract Development and Manufacturing Organization). They help biotech and pharmaceutical companies develop, manufacture, and scale complex medicines when those companies either do not have their own manufacturing capabilities or need additional capacity.

Think of them as the manufacturing partner behind the scenes for drug companies. A biotech company may discover a promising therapy, but making that therapy at commercial scale requires specialized facilities, equipment, quality systems, and regulatory expertise- working here, you're taking that product from development through clinical trials and into commercial manufacturing.

As part of our…