Qualifications

• High School Diploma with 6+ years GMP experience, or Master's with 2+ years, or Bachelor's with 4+ years in relevant fields.
• Demonstrated ability to communicate technical information effectively to varied audiences.
• Proven track record ensuring data integrity and regulatory compliance (cGMP, ICH, FDA, EMA).
• Experience managing multiple concurrent activities in biologics and drug development.
• Strong capabilities in influencing and mentoring stakeholders while aligning diverse interests.
• Leadership experience in strategic project design and cross-functional resource allocation.
• Active participation in Catalent's leadership programs may substitute for external experience.

Responsibilities

• Oversees downstream manufacturing operations to meet production schedules and quality standards.
• Leads, evaluates, and develops team members, addressing performance issues promptly.
• Communicates operational updates and policies to enhance team performance and engagement.
• Authors and maintains essential cGMP documentation and records.
• Prepares for internal and regulatory audits, providing expertise during technical discussions.
• Maintains and strengthens the Quality System with a focus on compliance and deviation investigations.
• Manages cleanroom operations, ensuring adherence to 5S and equipment readiness.
• Coordinates resource allocation and drives continuous improvement initiatives across shifts.

Benefits

• Defined career path with annual performance reviews.
• Emphasis on diversity and inclusion in the workplace.
• Opportunities for career advancement in a life-preserving organization.
• 152 hours of paid time off plus 8 paid holidays.
• Generous 401K matching program.
• Comprehensive medical, dental, and vision coverage.
• Tuition reimbursement for continuing education.