Manager, Manufacturing Technical Operations

$163,240 - $163,240/Yr

Catalent - Severn, MD

Full-time - Mid Level

Severn, MD

Chemical Manufacturing

About the position

The Manager, Manufacturing Technical Operations (MTO) at Catalent Pharma Solutions is responsible for overseeing and leading the Manufacturing Technical Operations group, which supports the manufacturing operations of advanced therapeutic products. This role involves ensuring compliance with cGMP standards, managing team performance, and facilitating communication between internal stakeholders and clients. The MTO group focuses on investigations, continuous improvement, operational excellence, and technology transfer support, ensuring that manufacturing processes are efficient and effective.

Responsibilities

• Build, lead and manage the MTO group to support ongoing and future manufacturing operations.
• Manage the interface of the MTO group with internal stakeholders and clients through proactive communication and accountability for on-time project/work completion.
• Oversee daily activity for the group to ensure quality results and performance management for direct reports.
• Drive timely completion of major manufacturing investigations and deviations and subsequent CAPAs.
• Oversee and coordinate manufacturing continuous improvement activities and establish a yearly slate of improvement projects.
• Support technology transfer teams by providing manufacturing representation.
• Provide effective oversight and coordination of manufacturing document generation & revision, BOM management, operations data analytics & metrics, and manufacturing suite readiness.

Requirements

• Masters' degree in a Scientific, Engineering or Biotech field with 3 years' experience in cGMP production &/or quality experience.
• OR Bachelor's degree in a Scientific, Engineering or Biotech field with 6 years' experience in cGMP production &/or quality experience.
• Minimum 3 years of progressive leadership experience, including performance management and people development.
• Knowledge of GMP's, FDA regulations and documentation procedures required.
• Experience in quality systems regulations and process deviation investigations.
• Excellent communication and technical writing skills.

Nice-to-haves

• Demonstrable leadership experience at Catalent, including participation in Catalent-sponsored leadership programs.
• Experience operating equipment such as incubators, single-use bioreactors, and chromatography skids.

Benefits

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Potential for career growth
• 152 hours of paid time off annually + 8 paid holidays
• Competitive salary with yearly bonus potential
• Community engagement and green initiatives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement