Finishing Manager

4 weeks ago

Plantation, United States Kelly Full time

Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a direct hire opportunity to work as an Aseptic Fill/Finish Manager located in Plantation, FL.


Job Type: Full-time


Job Description:

We are seeking a highly skilled and experienced Manager for Aseptic Fill Finish Manufacturing to oversee all aspects of our Fill Finish Manufacturing functions. The successful candidate will have hands-on responsibility for operational management and planning of Fill Finish activities. This role requires a strong understanding of GMP aseptic manufacturing processes and the ability to troubleshoot and execute these processes efficiently.


Key Responsibilities:

  • Develop and maintain Subject Matter Expert (SME)-level understanding of GMP aseptic manufacturing processes.
  • Expertly execute and troubleshoot automated and semi-automated fill-finish equipment.
  • Maintain the Aseptic Fill and Finish training matrix, ensuring staff compliance.
  • Provide operational support, including material stocking, kit preparation, and equipment maintenance.
  • Review documents, including Batch Records and Logbooks, and support documentation needs.
  • Lead Change Controls of SOPs, Batch Records, etc., as required.
  • Contribute to interdepartmental projects and technical transfers.
  • Mentor staff and identify training needs to ensure continuous improvement.
  • Work independently and in a team environment, adhering to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).
  • Lead departmental projects and escalate issues to management as needed.
  • Maintain compliance with regulatory requirements and ensure accurate data recording.


Required Qualifications:

  • Bachelor's degree or some post-secondary education.
  • Strong technical knowledge of automated aseptic processing in cleanroom environments.
  • Experience in aseptic manufacturing processes for sterile biologic drug substances and products.
  • Proficiency in Microsoft Excel, Word, and Outlook.
  • Ability to perform arithmetic and algebraic calculations accurately.
  • Proven leadership skills with experience in coaching, mentoring, and developing staff.
  • Excellent communication skills and the ability to manage change effectively.


Preferred Qualifications:

  • Minimum 2+ years of experience in pharma/biopharma GMP sterile manufacturing operations.
  • Familiarity with GXP best practices and FDA regulations.
  • Proactive, results-oriented self-starter with experience in complex manufacturing environments.


Visual Inspection Program:

  • Must be able to pass a Vision Exam.
  • Must not be color blind and must have 20/20 vision (can be corrected).


Interacts with:

  • All Cross-Functional Departments


APPLY NOW FOR IMMEDIATE CONSIDERATION

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