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Aseptic Manufacturing Specialist
2 months ago
Planet Pharma is seeking a highly skilled Aseptic Manufacturing Technician to join our team in the autologous cell therapy manufacturing program. As an Aseptic Manufacturing Technician, you will play a critical role in supporting manufacturing processes, ensuring the highest quality standards are met, and contributing to the success of our company.
Key Responsibilities:- Develop a comprehensive understanding of GMP cell therapy manufacturing processes and execute them proficiently.
- Complete training sessions and maintain accurate training documentation.
- 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 daily huddle meetings and escalate issues/concerns 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.
- 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 – 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 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.
A or B
Shift A-Rotation
Week 1
Sunday to Tuesday: 6:00PM – 6:30AM
Week 2
Sunday to Wednesday : 6:00PM – 5:30AM
OR
Shift B-Rotation
Week 1
Wednesday to Saturday: 6:00PM – 5:30AM
Week 2
Thursday to Saturday: 6:00PM – 6:30AM
