Job Information
RESILIENCE US INC Senior Manager, MSAT Sterile Ops Technical Team in Hamilton, Ohio
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.
Responsibilities
- 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
- 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
Sponsorship or support for work authorization, including visas, is not available for th