Director, MTO

Job Title: Director, MTO

Location: Harmans, MD

POSITION SUMMARY

The Director, Manufacturing Technical Operations (MTO) is responsible for oversight and leadership of MTO group that supports manufacturing operations at Catalent.  The Manufacturing Technical Operations group functions include investigations, deviations, continuous improvement (change controls, CAPAs) operational excellence (major projects), investigator training program, data analytics & metrics, and manufacturing readiness.  

The Role

• Build, lead and manage the MTO group to support on-going and future manufacturing operations. 
• Advances the oversight of the deviation and CAPA management for the site and performance of the Deviation and CAPA review boards.
• Ensures effective training program and performance measures for investigators.
• Drives timely completion of manufacturing investigations and deviations.
• Drives timely completion of manufacturing CAPAs.
• Oversight and coordination of manufacturing continuous improvement (e.g. CAPAs, Change Controls) and operational excellence activities; establish and manage a yearly slate of improvement projects with measurable results aligned with the site’s objectives.
• Provides data analytics and metrics to ensure timely completion of records and readiness.
• Manage the interface of the MTO group with internal stakeholders and clients through proactive communication and accountability for on-time work completion.
• Effectively communicates status and results of department and project work internally and externally (clients).
• Interacts with clients on projects and presentations; Oversees and coaches team member client interactions.
• Leads by example, keeping in mind organizational values, policies and goals. Develops people and team coaching and collaboration.
• Proactively partners with Human Resources to attract and retain top talent and takes an active role in ensuring new employee onboarding is a success.

The Candidate:

• Masters’ degree in a Scientific, Engineering or Biotech field with 10 – 12 years’ experience in cGMP production &/or quality experience, with knowledge and understanding of process, documentation requirements and activities

OR

• Bachelor’s degree in a Scientific, Engineering or Biotech field with 12– 14 years’ experience in cGMP production &/or quality experience, with knowledge and understanding of process, documentation requirements and activities

OR

• Associate Degree or HS Diploma with 14 – 16 years’ experience in cGMP production &/or quality experience, with knowledge and understanding of process, documentation requirements and activities
• 5 – 7 years’ Progressive Leadership experience, experience with Performance Management, Goal Setting and Managing through Conflict. 
• Knowledge of GMP’s, FDA regulations and documentation procedures required
• Experience in quality systems regulations. 
• Previous experience operating equipment such as: incubators, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment.
• Previous experience in process deviation investigations and remediation
• Previous experience authoring and/or revising technical documents
• Demonstrated ability to work effectively cross-functionally, lead teams and implement project plans on time and on budget.
• Excellent communication and technical writing skills
• Ability to support and/or lead system troubleshooting efforts.
• Familiar with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities.
• Creative thinking with the ability to multi-task.
• Commitment to ongoing professional development.
• Team player who thrives in collaborative environments and revels in team success.
• Solid communication skills across technical and non-technical audiences and the ability to create and communicate complex concepts and analyses in easy-to-understand ways.

Pay:

The anticipated salary range for this position in Maryland is $188,320 - $238,940 plus variable incentive compensation. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. 

Why You Should Join Catalent