Senior Manager, MSAT

Resilience
paid holidays, tuition reimbursement, flex time, 401(k)
United States, North Carolina, Durham
1733 TW Alexander Drive (Show on map)
Apr 10, 2025
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: This role is responsible for the management and oversight of the MSAT process transfer team. The process transfer Senior Manager will lead a team of scientists and engineers driving technology transfer activities at the site, supporting those processes through manufacturing and batch release. Additionally, this role will support regulatory, site, and corporate audits with subject matter experts on tech transfer and process control strategy. Position Responsibilities: Provide leadership to process transfer SMEs with their day to day deliverables Oversee the technology transfer efforts within the team and working with the technical leads to troubleshoot process transfer roadblocks, escalating as necessary to site leadership Build and maintain strong collaborations across functions at the site, ensuring alignment with tech transfer priorities Develop and drive strategies to increase technology transfer and technical competency maturity In close partnership with the cross functional site teams, ensure processes are fit for operations. Provide ownership and leadership of quality events assigned to or supported by MSAT (CAPAs, deviations, document revisions). Develop and maintain documents related to SOP's, Work Plans, Job Aids, Policies and Procedures, Specifications, etc. Collaborate with cross-functional Resilience team, including EHS, Manufacturing, Engineering, Facilities, OE/Project Management, Quality Assurance, Quality Control, IT, People Partners, Finance and Site Leadership to deliver site goals Minimum Qualifications: Prior experience in biopharmaceutical manufacturing Prior experience in technology transfer and new product introduction Prior experience managing technical SMEs Familiar with FDA and EU regulations and GMP standards. First-hand experience with agency filings and inspections. Independently motivated, detail oriented and good problem-solving ability. Preferred Qualifications: Prior cGMP cell or gene therapy manufacturing experience is highly desired. BS/MS in Engineering or a related field 5 years of experience in pharmaceutical/biotech manufacturing 5 years of managerial experience 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 equity, 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, flexible time off, 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 - $190,000.00 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 and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.