Laboratory Technician
4 weeks ago
Planet Pharma is seeking a highly skilled Laboratory Technician to join our team in Philadelphia, PA.
Job Summary:The Laboratory Technician will be responsible for supporting the autologous cell therapy manufacturing program by executing GMP cell therapy manufacturing processes, completing training sessions, and maintaining quality standards.
Key Responsibilities:- Develop a comprehensive understanding of GMP cell therapy manufacturing processes and execute them proficiently.
- Complete training sessions and ensure training documentation is maintained.
- Understand and comply with quality standards and requirements as documented.
- 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.
- Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
- Attend the daily huddle meeting and escalate issues/concerns at that forum to Area Management for further investigation.
- Ability to work in a team environment and independently as required.
- Must adhere to core values, policies, procedures, and business ethics.
- Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
- Perform miscellaneous duties as assigned.
- Bachelor's degree or some post-secondary education.
- Minimum 0-1 years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
- Must be able to deal with ambiguity and manage constant change.
- Must be able to read, write, and understand English for Good Documentation Practices.
- Proficient in Microsoft (Excel, Word, Outlook).
- Ability to perform arithmetic calculations, including fractions, decimals, and percentages, and basic algebraic and geometric calculations accurately and reproducibly.
- Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
- Proactive, results-oriented, self-starter with experience in a complex manufacturing environment.
- Ability to build relationships quickly and credibly.
- Ability to work successfully in a fast-paced, team-oriented environment.
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