Senior Manager of Manufacturing

Role Overview

The Senior Manager of Manufacturing will oversee day‑to‑day operations for the commercial aseptic manufacturing of drug and device products. The role spans activities in Compounding, Equipment/Component Preparation, Sterile Filling, Inspection, and Packaging, ensuring that supervisors provide daily oversight, maintain compliance with company SOPS, GMP, and regulatory requirements (FDA, OSHA, OFCCP, EPA), and drive continuous operational improvement.

• Lead, coach, and develop a team of supervisors and non‑exempt employees, including hiring, onboarding, performance management, and career development.
• Ensure production schedules are met while upholding quality, safety, and regulatory compliance.
• Drive continuous improvement initiatives to eliminate non‑value‑added activities and enhance OEE, throughput, and profitability.
• Manage and lead daily manufacturing operations across one or more value streams.
• Champion the implementation of SOPs, CAPA, change control, and validation activities, participating in internal and external audits.
• Interface with customers, regulatory agencies, and cross‑functional teams to address issues, provide updates, and support product quality commitments.
• Prepare and submit quality reports, CAPA action plans, and lead investigations.
• Maintain a culture of compliance, safety, and continuous learning.

• Strong oral and written communication skills.
• Excellent time management, organizational, and project management abilities.
• Ability to work autonomously, manage time effectively, and deliver results.
• Knowledge of MS Office suite and aseptic manufacturing, isolator technology, and cleanroom operations.
• Experience with cGMP compliance and regulatory environments (FDA, OSHA, OFCCP, EPA).
• Leadership skills fostering a healthy, collaborative, and innovative culture.

Bachelor of Arts or Science degree required;
Master’s degree preferred. Minimum 5 years supervisory experience in a cGMP regulated industry, and minimum 7 years in aseptic manufacturing, pharmaceutical or medical industry with progressive leadership experience.

• Annual salary range: $156,000 - $185,000.
• Healthcare, life insurance, disability, and vision coverage.
• Profit sharing and 401(k) plan with employer match.
• Paid time off, holidays, and sick leave.
• Additional benefits may include tuition reimbursement, wellness programs, and other company benefits, contingent on eligibility.

American Regent celebrates diversity and is committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: https://(Use the "Apply for this Job" box below). Know Your Rights:
Workplace discrimination is illegal (eeoc.gov).