Qualifications

• Bachelor's, Master's, or Doctorate in a STEM discipline with 8-15+ years of experience.
• 5+ years of leadership experience in a relevant field.
• Strong technical knowledge of biologics manufacturing and GMP principles.
• Active experience during regulatory inspections and knowledge of compliance requirements.
• Expertise in deviation investigations, CAPAs, SOPs, and batch record authoring.
• Familiarity with LEAN systems and continuous improvement methodologies.
• Excellent communication skills for presenting to varied audiences.

Responsibilities

• Direct technical leadership for manufacturing and process transfers.
• Manage and review documentation and compile process data.
• Provide technical input for deviations, change controls, and CAPAs.
• Define and execute department strategy based on scientific data.
• Collaborate with cross-functional teams including Process Development and QA/QC.
• Analyze process data, identify trends, and present findings.
• Maintain a high-performing team through hiring and development.

Benefits

• Defined career path with regular performance reviews.
• Diverse and inclusive workplace culture.
• Opportunities for career growth within a rapidly expanding organization.
• Dynamic and fast-paced work environment.
• Engagement in community service and environmental initiatives.
• Generous 401K match and PTO accrual.
• Comprehensive medical, dental, and vision benefits starting on the first day of employment.