Senior Manager, Manufacturing Technical Operations

3 weeks ago


Harmans, Maryland, United States Catalent Full time
Job Summary

Catalent is seeking a Senior Manager, Manufacturing Technical Operations to oversee the daily activities of the MTO group, ensuring quality results and adherence to safety guidelines. The successful candidate will build, lead, and manage the MTO group to support ongoing and future manufacturing operations.

Key Responsibilities
  • 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.
  • Performance management for direct reports and drives timely completion of major manufacturing investigations and deviations and subsequent 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.
Requirements
  • Masters' degree in a Scientific, Engineering or Biotech field with 5-7 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 8+ years' experience in cGMP production &/or quality experience, with knowledge and understanding of process, documentation requirements and activities.
  • Previous management and leadership experience and will promote a positive experience for employees.
  • Knowledge of GMP's, FDA regulations and documentation procedures required.
  • Experience in quality systems regulations; Previous experience in process deviation investigations and remediation; to include authoring and/or revising technical documents.
What We Offer
  • Competitive salary with yearly bonus potential.
  • Defined career path and annual performance review and feedback process.
  • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
  • 152 hours of paid time off annually + 8 paid holidays.
  • Generous 401K match and Paid Time Off accrual.
  • Medical, dental and vision benefits effective day one of employment.
  • Tuition Reimbursement.


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