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Senior Aseptic Manufacturing Specialist

2 months ago

Philadelphia, Pennsylvania, United States Planet Pharma Full time

Senior Aseptic Manufacturing Specialist Required

Position Overview:

The Senior Aseptic Manufacturing Specialist plays a crucial role in guiding and overseeing the Aseptic Manufacturing teams. This position necessitates a comprehensive understanding of methodologies, practices, and principles to support the manufacturing processes effectively. The Specialist will lead various tasks, including cleaning, sanitization, preparation, and the fulfillment of products intended for both commercial and clinical applications. A strong background in cell culture, aseptic gowning, qualification, and operations within an ISO class 5 cleanroom is essential for success in this role. The position requires flexibility to work across different shifts, with potential overtime on weekends and holidays to ensure the successful completion of manufacturing processes.

Key Responsibilities:

  • Develop a deep understanding of GMP cell therapy manufacturing processes and demonstrate the ability to execute and troubleshoot effectively.
  • Identify training requirements and establish a feedback mechanism to promote continuous improvement.
  • Conduct training sessions and maintain accurate training documentation.
  • Ensure compliance with quality standards and requirements, aligning training schedules with production and quality objectives.
  • Provide operational support, including materials management, kit preparation, reagent setup, room readiness, cleaning, and equipment upkeep.
  • Review documentation, including Batch Records and Logbooks, for accuracy.
  • Assist in the preparation and approval of SOPs, Batch Records, Deviations, and CAPAs, making necessary revisions to reflect current practices.
  • Manage documentation Change Controls for SOPs and Batch Records as required.
  • Contribute to interdepartmental and departmental projects as needed.
  • Support technical transfers and additional research-level testing activities.
  • Handle moderately complex assignments, exercising judgment to resolve operational challenges without hindering manufacturing efforts.
  • Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
  • Ensure accurate data recording to meet regulatory requirements.
  • Participate in daily meetings, escalating issues or concerns to management for further investigation.
  • Demonstrate the ability to work both collaboratively in a team environment and independently as necessary.
  • Execute routine assignments according to established procedures, recognizing deviations from accepted practices.
  • Work in a cleanroom environment with biohazards, human blood components, and chemicals.
  • Comply with Safety SOPs, SDS sheets, and laboratory procedures in accordance with company policy and OSHA regulations.
  • Perform additional duties as assigned.

Required Qualifications:

  • Bachelor's degree or equivalent post-secondary education.
  • Proven technical expertise in aseptic processing within cleanroom settings is essential.
  • Ability to mentor and share best practices with team members.
  • Capable of adapting to change and managing ambiguity effectively.
  • Proficient in reading, writing, and understanding English for Good Documentation Practices.
  • Skilled in using computers and Microsoft Office applications (Excel, Word, Outlook).
  • Adept at performing arithmetic calculations accurately, including fractions, decimals, percentages, and basic algebraic and geometric calculations.
  • Ability to build relationships quickly and establish credibility.
  • Experience working successfully in a fast-paced, team-oriented environment.

Preferred Qualifications:

  • Over 3 years of experience in biopharmaceutical GMP manufacturing operations, particularly in cell culture and downstream processing.
  • Quality-focused mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
  • Proactive, results-driven individual with experience in complex manufacturing environments.