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Lead Aseptic Manufacturing Technician

3 months ago

Philadelphia, United States Planet Pharma Full time

Lead Aseptic Manufacturing Technician needed


Overview:

The Lead Aseptic Manufacturing Tech role helps provide guidance and leadership to the Aseptic Manufacturing Technicians’ teams. This position requires a broad understanding of theories, techniques, and principles to support manufacturing processes. The Lead Manufacturing Technician will be responsible for and lead others in various tasks, such as cleaning, sanitization, preparation, and fulfilling products for commercial and clinical use. To excel in this role, the candidate strongly desires a background in cell culture, aseptic gowning, qualification, and ISO class 5 cleanroom operations. This position works across different shifts. Depending on your assigned shift, you may be required to work overtime on weekends and holidays to complete the manufacturing process successfully.


Essential Functions and Responsibilities:

  • Develop a Subject Matter Expert (SME)-level understanding of and can execute as skillfully as well as troubleshoot GMP cell therapy manufacturing process(es).
  • Assists with identifying training needs, establishing a feedback loop to ensure continuous improvement.
  • Deliver training sessions and ensure training documentation is maintained.
  • Understand and comply with quality standards and requirements as documented. Ensure training schedules meet company production and quality targets.
  • Provide operational support functions, including materials stocking and transfer, kit preparation, reagent preparation, room readiness, cleaning activities, and equipment maintenance.
  • Perform document review, including executed Batch Records and Logbooks.
  • Support documentation needs, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to reflect current procedures accurately.
  • Execute documentation Change Controls of SOPs, Batch records, etc., as needed.
  • Support interdepartmental and departmental projects in a contributor capacity.
  • Supports technical transfer and additional research-level testing activities as needed.
  • May work on moderately complex assignments, requiring judgment to resolve operational issues without negatively impacting manufacturing efforts.
  • Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
  • Completes recording of data to comply with regulatory requirements.
  • Attend or hold the daily huddle meeting and escalates issues/concerns at that forum to Area Management for further investigation.
  • Ability to work in a team environment and independently as required.
  • Works on routine assignments per written procedures, where the ability to recognize deviation from accepted practice is required.
  • Work in a cleanroom with biohazards, human blood components, and chemicals
  • Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
  • Perform miscellaneous duties as assigned.


Required Education, Skills, and Knowledge:

  • Bachelor's degree or some post-secondary education.
  • Demonstrated technical knowledge of aseptic processing in cleanroom environments is a must.
  • Ability to mentor and provide best practices to other team members.
  • Must be able to work with ambiguity – ready to change gears and plans quickly and manage constant change.
  • Must be able to read, write and understand English for Good Documentation Practices
  • Proficient with computers and Microsoft (Excel, Word, Outlook) programs.
  • Ability to perform arithmetic calculations accurately and reproducibly, including fractions, decimals, percentages, and basic algebraic and geometric calculations.
  • Ability to build relationships quickly and credibly.
  • Ability to work successfully in a fast-paced, team-oriented environment.

Preferred Education, Skills, and Knowledge:

  • 3+ years of experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
  • Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulation
  • Proactive, results-oriented, self-starter with experience in a complex manufacturing environment