Senior Manager, MSAT Sterile Ops Technical Team

Resilience; Port Union (OH); On-site; USD 130,000 - 193,750; Full time

Job summary

Resilience, a technology-focused biomanufacturing company, seeks a Director-level MSAT lead in Ohio to guide tech transfer in a cGMP environment and implement new processes and equipment.

You will direct a team of MSAT Specialists, develop site Tech Transfer standards, ensure PPQ compliance, and partner with Quality, Validation, PMO, and Operations to drive continuous improvement and risk-based decisions.

Qualifications

• Extensive experience in aseptic operations, formulation, aseptic filling, visual inspection, device assembly, and/or packaging in a regulated environment.
• Strong leadership capabilities with coaching and communication skills.
• Experience with Technology Transfer in a GMP environment.

Responsibilities

• Lead the MSAT Technical team with focus on people management and coaching to develop a high performing organization.
• Own the development and maintenance of standards for site Tech Transfer activities to ensure validated processes.
• Accountable for site technical support for Tech Transfer from initial evaluation to PPQ in GMP compliance.
• Document key technical decisions with GMP risk management and data support.
• Promote lean thinking and a culture of continuous improvement.
• Maintain relationships with PMO, Validation, Quality, and Operations stakeholders.
• Foster external technical relationships with equipment and material suppliers.
• Stay updated on technology trends through literature and guidelines.
• Develop business cases for new opportunities and technologies.

Skills

Aseptic operations

GMP/Tech Transfer

Team leadership

Education

Bachelor's degree in engineering or related discipline

Job description

Relocation Assistance Offered

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

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.

Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $130,000.00 - $193,750.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience? We encourage you to apply and start a conversation with one of our recruiters.

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.