The Aseptic Manufacturing Technician I role is crucial for the autologous cell therapy manufacturing program. This position requires a broad understanding of theories, techniques, and principles to support manufacturing processes. As an Aseptic Manufacturing Technician I, you will be responsible for various tasks, such as cleaning, sanitization, preparation, and fulfilling products for commercial and clinical use. To excel in this role, the candidate strongly desires to have a background in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operations.
Essential Functions and Responsibilities:
Develop a comprehensive understanding of and be able to proficiently execute GMP cell therapy manufacturing process(es).
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). Completes recording of data to comply with regulatory requirements.
Attend 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.
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.
Required Education, Skills, and Knowledge:
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.