AMANJEET SINGH
Riverside,CA
Summary
Dedicated Cell Therapy Specialist experienced in autologous and allogeneic therapies. Skilled in aseptic techniques, including buffer preparation, cryopreservation, and final fill within ISO5/GMP standards, with strengths in equipment troubleshooting. Experienced in drafting MABRs, APSs, AOQs, and SOPs while supporting deviations and CAPAs. Focused on driving process improvements to support organizational goals.
Overview
4
4
years of professional experience
Work History
Cell Therapy Specialist
Astrazeneca
12.2024 - Current
- Oversaw daily production operations for a team of 3-6 individuals, managing resource allocation and task prioritization to meet manufacturing needs.
- Guided and trained manufacturing team on equipment and aseptic technique as main point of escalation in cleanroom for shift.
- Drafted AOQ and APS documents in collaboration with MSAT, PD, QA, and QCM, meeting all regulatory and company standards.
- Drafted and revised 10+ SOPs compliant with GMP and regulatory standards.
- Coordinated installation qualification and operational qualification (IQOQ) for cleanroom equipment in allogeneic program, ensuring compliance and readiness for production.
- Completed deviations and CAPAs per SOPs, leading to streamlined process improvements.
- Assisted cleanroom launch for allogeneic program by overseeing installation of critical equipment, drafting process documents, defining team roles, and executing startup tasks.
- Coordinated cross-functional teams to ensure timely project completion.
- Implemented process improvements to increase efficiency and reduce costs.
Manufacturing Associate
Editas Medicine
02.2023 - 12.2024
- Executed duties according to standard operating procedures for cellular product manufacturing under GXP guidelines.
- Maintained a clean room environment while fully gowned, adhering to GMP guidelines and aseptic techniques.
- Operated instrumentation essential for cell manufacturing processes.
- Completed batch record documentation, equipment log entries, and GMP documentation to ensure regulatory compliance.
- Resolved deviations and CAPAs in alignment with SOPs, ensuring prompt compliance and resolution.
- Edited and updated SOPs to align with current standards and guidelines.
- Organized laboratory workspace to optimize workflow efficiency and ensure safety regulation compliance.
- Adhered to all relevant laboratory regulatory and safety requirements.
EMT
PMT
08.2022 - 02.2023
- Assessed the nature and extent of injury or illness to establish and prioritize medical procedures to be followed.
- Provided basic life support to patients at scene of incidents, en route to hospital, and in a pre hospital setting in accordance with federal, state, and local laws, regulations and standards.
- Completed thorough patient care reports documenting assessments, physical findings, patient information, history, and billing in accordance with HIPAA to ensure accurate medical records.
- Stocked and maintained ambulance equipment and followed sanitation procedures, enhancing patient and worker safety.
Education
Bachelor of Science - Biology
UCR
Riverside06-2022
Skills
- Aseptic technique
- SOP drafting
- GMP compliance
- APS and AOQ compliance
- Process validation
- Deviation Management
- Material Management
References
- Peter, Schindler, peters.schindler@astrazeneca.com, 805-573-8359, AstraZeneca
LANGUAGES
- English
- Punjabi
- Hindi
Timeline
Cell Therapy Specialist
Astrazeneca
12.2024 - Current
Manufacturing Associate
Editas Medicine
02.2023 - 12.2024
EMT
PMT
08.2022 - 02.2023
Bachelor of Science - Biology
UCR