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.
Requirements
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
Bachelor's degree in engineering or a related discipline
Ability to generate and interpret technical documents
Training in, or awareness of, lean six sigma and lean manufacturing
Sponsorship or support for work authorization, including visas, is not available for this position.
As a requirement of this role, employees must have the ability to demonstrate and maintain gown qualification standards. Please review the video below, which outlines the most extensive process to gown within specific areas of Sterile Operations at Resilience, West Chester
Benefits
Health insuranceDental insuranceVision insurance401(k)Paid time offPerformance bonus
Additional Information
A career at Resilience is more than just a job - it's an opportunity to change the future.
Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made . We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
For more information, please visit www.resilience.com
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.
Resilience · - OH - West Chester