AMANJEET SINGH
Riverside
Summary
Motivated cell therapy specialist functioning as the interim lead with strong experience in autologous and allogeneic cell therapy. Proficient in aseptic techniques—buffer prep, cryo-prep, and final fill—in ISO5/GMP environments, with added strengths in equipment troubleshooting. Quick learner and team-oriented contributor with copious experience drafting MABRs, APSs, AOQs, SOPs, and supporting deviations and CAPAs. Committed to driving process improvements and seeking a growth-focused full-time opportunity aligned with company goals.
Overview
3
3
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.
- Helped guide and train manufacturing team on equipment and aseptic technique while serving as the main point of escalation in the cleanroom for my 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 pioneering allogeneic program.
- Completed deviations and CAPA's per SOPs, leading to streamlined process improvements.
- Assisted cleanroom launch for allogeneic program; overseeing installation of critical equipment, drafting of process documents, defining team roles, and performing startup tasks.
Manufacturing Associate
Editas Medicine
02.2023 - 12.2024
- Perform duties as dictated by standard operating procedures (SOPs) for cellular product manufacturing and under GxP guidelines as directed.
- Complete deviations and CAPAs in accordance to SOPs and work instructions in a timely manner.
- Edit and improve SOPs to reflect current standards and guidelines.
- Work in a clean room environment while fully gowned following GMP guidelines and using aseptic technique.
- Work in a Biological Safety Cabinet for open processing operations.
- Operate instrumentation needed for cell manufacturing.
- Accurately complete batch record documentation, all appropriate equipment log entries, and GMP documentation.
- Maintain orderly lab space.
- Maintain sufficient inventory of supplies and reagents for performance of duties.
- Clean and maintain laboratory equipment in good working order.
- Prepare solutions and culture media as appropriate.
- Work in compliance with all appropriate laboratory regulatory and safety requirements.
EMT
PMT
08.2022 - 02.2023
- 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.
- Assessed the nature and extent of injury or illness to establish and prioritize medical procedures to be followed.
- Completed patient care reports thoroughly documenting all assessments and physical findings of the patient along with patient information, history, and billing information in accordance with HIPPA.
- Stocked and maintained all equipment in the ambulance and followed sanitation procedures to ensure patient and worker safety.
Education
Bachelor of Science - Biology
UCR
Riverside06.2022
Skills
- Aseptic Technique
- GxP practices
- Veeva
- Microsoft Office
- Leadership
- Continuous improvement
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