Manufacturing Operations Manager

1 day ago


West Chester, Pennsylvania, United States BioSpace, Inc. Full time
Job Summary

We are seeking a highly skilled and experienced Manufacturing Operations Manager to lead our Sterile Filling Operations team. As a key member of our operations team, you will be responsible for ensuring the efficient and effective production of high-quality products while maintaining compliance with regulatory requirements.

Key Responsibilities
  • Provide direction to personnel in the efficient use of equipment and materials to produce quality products.
  • Responsible for all Operations activity, including coordination of support staff, scheduling, and improvement.
  • Promote the use of safe work practices during all aspects of production and ensure all external and company EHS standards are met.
  • Accountable for training of personnel on equipment, processes, and Standard Operating Procedures.
  • Ensure that cGMPs are used and followed during production of products to meet FDA and international regulations.
  • Promote a positive work environment and communicate information to employees and respond to their concerns.
  • Ensure proper documentation practices are maintained consistently to company standards.
  • Generate reports for deviations, assist in investigations, and recommend/implement solutions to resolve deviations.
  • Author, review, and approve Standard Operating Procedures and other documents to ensure integration of cGMPs and improve process efficiencies.
  • Promote and encourage continuous improvement in efficiency, quality, production, and safety through the use of team-driven processes and key performance indicators.
Requirements
  • Experience in GMP or regulated production environment.
  • Previous supervisory experience in Food or Pharmaceutical manufacturing.
  • Experience working in a LEAN manufacturing environment.
  • Knowledge of FDA cGMPs.
  • Strong communication and leadership skills.
  • Problem-solving skills.
Preferred Qualifications
  • Bachelor of Science in Engineering, Pharmacy, related Science, or business.
  • Working knowledge of LDMS or Microsoft applications, SAP, Veeva.
  • Training or experience in formulation, filling, packaging, validation, technology transfer, change control.
  • Knowledge or previous experience in managing technical programs/projects.
  • Strong troubleshooting and problem-solving abilities.
  • Ability to direct and participate in cross-functional teams.

We offer a competitive salary range of $100,000.00 - $141,250.00 per year, a robust total rewards program, and a comprehensive benefits package. If you are a motivated and experienced professional looking for a challenging opportunity, please apply and start a conversation with one of our recruiters.



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