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

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Dynamic, fast-paced work environment.
• 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

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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