Manufacturing Operations Manager

8 hours ago


Severn, Maryland, United States Catalent Pharma Solutions, Inc. Full time
Job Summary

Catalent Pharma Solutions, Inc. is seeking a highly skilled Manufacturing Operations Manager to lead our biologics production team. As a key member of our operations team, you will be responsible for ensuring the smooth execution of manufacturing processes, maintaining compliance with regulatory requirements, and driving process improvements.

Key Responsibilities
  • Lead and manage a team of manufacturing professionals to execute production processes, ensuring timely delivery of high-quality products.
  • Develop and implement process improvements to increase efficiency, reduce costs, and enhance product quality.
  • Collaborate with cross-functional teams to resolve production issues, implement changes, and ensure compliance with regulatory requirements.
  • Develop and maintain Standard Operating Procedures (SOPs) and batch records to ensure accurate and compliant documentation.
  • Conduct regular audits and inspections to ensure adherence to GMP guidelines and regulatory requirements.
  • Provide training and guidance to team members on manufacturing processes, equipment operation, and quality control procedures.
  • Participate in process validation and qualification activities to ensure compliance with regulatory requirements.
  • Develop and implement corrective actions to address deviations and non-conformities.
Requirements
  • Bachelor's degree in a scientific or engineering field, or equivalent experience.
  • Minimum 6-8 years of experience in biologics manufacturing, with a focus on GMP compliance and process improvement.
  • Proven leadership and management experience, with a track record of driving process improvements and team performance.
  • Strong knowledge of GMP guidelines, regulatory requirements, and industry standards.
  • Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
  • Ability to analyze complex data, identify trends, and develop recommendations for process improvements.
What We Offer
  • A competitive salary and bonus structure.
  • A comprehensive benefits package, including medical, dental, and vision coverage.
  • A 401(k) matching program and tuition reimbursement.
  • A dynamic and supportive work environment, with opportunities for professional growth and development.


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