Director MTO
Director MTO
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Job Description
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 ongoing 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 sites 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 ontime 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
- Bachelors 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 GMPs FDA regulations and documentation procedures required
- Experience in quality systems regulations.
- Previous experience operating equipment such as: incubators singleuse bioreactors depth filtration skids TFF skids chromatography skids singleuse 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 crossfunctionally 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 multitask.
- Commitment to ongoing professional development.
- Team player who thrives in collaborative environments and revels in team success.
- Solid communication skills across technical and nontechnical audiences and the ability to create and communicate complex concepts and analyses in easytounderstand ways.
Pay:
The anticipated salary range for this position in Maryland is $188320 $238940 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 multistate 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 fastpaced 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 7000 lifesaving and lifeenhancing 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 . 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.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment bank details photocopies of identification social security number or other highly sensitive personal information during the offer process and we NEVER do so via email or social media. If you receive any such request DO NOT respond it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
Required Experience:
Director
Employment Type
Full-Time
