Senior Manager, MSAT Sterile Ops Technical Team

Resilience; Kentucky; On-site; USD 100,000 - 130,000; Full time

Job summary

A biomanufacturing technology firm is seeking a Senior Manager for the MSAT Sterile Ops Technical Team. This role involves leading the technical team, managing tech transfer processes, and ensuring compliance with cGMP standards. Ideal candidates will have extensive experience in aseptic operations and strong leadership skills. The position is full-time, located in United States, Kentucky, offering an opportunity to impact the future of medicine.

Qualifications

• Extensive experience in aseptic operations and formulation in a regulated environment.
• Strong leadership abilities and effective communication skills.
• Experience with Technology Transfer in a GMP environment.

Responsibilities

• Lead the MSAT Technical team focused on people management.
• Own the development of standards for Tech Transfer activities.
• Accountable for site technical support for the Tech Transfer process.
• Maintain relationships with PMO, Validation, Quality, and Operations Stakeholders.

Skills

Aseptic operations

Leadership capabilities

Technology Transfer

Lean manufacturing

Education

Bachelor’s degree in engineering or a related discipline

Job description

.Senior Manager, MSAT Sterile Ops Technical Team page is loaded## Senior Manager, MSAT Sterile Ops Technical Teamlocations: USA - OH - West Chestertime type: Full timeposted on: Posted 18 Days Agojob requisition id: R-106731A 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 visitPosition Summary & ResponsibilitiesThis 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 environmentPreferred 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***Sponsorship or support for work authorization, including visas, is not available for this position.***Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.*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.*[](blob:https://resilience.wd1.myworkdayjobs.com/62acfa1a-5d74-4f5c-bfeb-6f7ded4bf429)0:00 / 3:49