Emily Christensen
South San Francisco,USA
Summary
GMP and cell therapy manufacturing professional with 6+ years of progressive experience spanning cell and plasmid manufacturing, MSAT, technology transfer, manufacturing operations, equipment qualification, automated systems, SOP development, electronic batch records, training, and quality-focused operations. Proven ability to build and train high-performing manufacturing teams, develop foundational SOPs and training materials, support novel automated manufacturing technologies, and partner closely with software and field service engineers to maintain reliable production operations. Experienced in GMP documentation, deviation investigations, audit readiness, cleanroom operations, controlled-rate freezing, automated cryogenic storage, and cross-functional process implementation. Recognized for creating safe, effective, compliant, and quality-focused manufacturing environments while supporting organizational growth and operational readiness.
Overview
1
1
Language
1
1
Certification
9
9
years of professional experience
Work History
Senior Cell Therapy Manufacturing Specialist
Cellares
South San Francisco, USA
12.2024 - 08.2026
- Built and supported a high-performing cell therapy manufacturing team, participating in hiring activities, onboarding, qualification, training, and development of manufacturing personnel.
- Authored, redlined, and implemented foundational equipment, process, and manufacturing SOPs and batch records, including documentation supporting novel automated manufacturing technologies and evolving operational processes.
- Partnered extensively with software engineers, field service engineers, manufacturing, MSAT, and cross-functional stakeholders to troubleshoot and optimize automated technology, supporting reliable equipment performance and manufacturing continuity.
- Managed automated cryogenic storage operations and supported the safe, compliant handling and storage of critical biological materials within a GMP manufacturing environment.
Cell Therapy Manufacturing Specialist
Cellares
South San Francisco, USA
11.2023 - 12.2024
- Supported process development and GMP cell culture manufacturing activities across the Cellares automated platform and client manufacturing platforms.
- Authored and redlined Manufacturing, MSAT, and EHS documentation, including SOPs, manufacturing batch records, policies, and supporting technical documentation.
- Built and implemented cleanroom layouts and contributed to manufacturing infrastructure and operational readiness initiatives.
- Led manufacturing-area audit tours and clearly presented manufacturing processes, controls, and operational capabilities during regulatory activities supporting the company's drug manufacturing license in San Mateo County.
Manufacturing Associate III
Triumvira Immunologics, Inc.
South San Francisco, USA
10.2022 - 10.2023
- Authored and maintained Excel-based and Tempo electronic batch records to support controlled, traceable GMP manufacturing operations.
- Redlined and authored equipment, health, safety, and manufacturing SOPs, translating operational requirements into clear and executable procedures.
- Onboarded new manufacturing equipment and coordinated equipment installation, commissioning, and qualification activities across cross-functional teams.
- Designed equipment qualification protocols and supported execution of qualification activities to establish equipment readiness for GMP operations.
Bioprocess Manufacturing Associate II
PACT Pharma
South San Francisco, USA
03.2021 - 10.2022
- Served as a GMP cell and plasmid manufacturing subject matter expert and trainer, supporting manufacturing execution and knowledge transfer across the team.
- Scheduled manufacturing activities, coordinated material orders, equipment maintenance, and training requirements to maintain operational readiness.
- Performed process development, data analysis, and statistical analysis to support manufacturing and process improvement initiatives.
- Authored and redlined SOPs and Master Batch Records to strengthen process consistency, documentation quality, and GMP execution.
Bioprocess Manufacturing Technician
Genentech and U.S. Tech Solutions
07.2020 - 03.2021
- Prepared GMP manufacturing equipment, including execution and support of SIP and CIP activities in a controlled production environment.
- Supported equipment preparation and manufacturing readiness while maintaining adherence to GMP procedures and operational requirements.
- Trained personnel on equipment preparation activities and helped reinforce consistent execution of production-support procedures.
- Implemented Slack-based communication practices to improve coordination between supervisors, leads, groups, and technicians within Production Services.
Undergraduate Research Assistant
Dr. Andres Martinez
San Luis Obispo, USA
06.2018 - 07.2020
- Planned, modified, and executed research techniques, laboratory procedures, and experimental tests in support of ongoing research programs.
- Prepared technical materials for reports, presentations, and submissions to peer-reviewed scientific publications.
- Developed hands-on expertise in point-of-care microPAD technologies and analytical chemistry.
- Organized and interpreted experimental information to support research documentation and scientific communication.
Undergraduate Research Assistant
Dr. Heather Liwanag
San Luis Obispo, USA
03.2017 - 07.2020
- Supported field research activities involving elephant seal population studies, including tagging, weighing, data collection, and documentation.
- Performed data entry and analysis to support population research and scientific reporting.
- Trained new research assistants on safety, tagging, weighing, and established field research procedures.
- Communicated research activities and scientific information to members of the public through public-relations training.
Education
Bachelor of Science - Biological Sciences
California Polytechnic State University
San Luis Obispo, CASkills
GMP Manufacturing Cell Therapy Manufacturing Plasmid Manufacturing Automated Manufacturing Platforms Automated Cryogenic Storage Electronic Batch Records Tempo MES LIMS SCADA SAP Slack Equipment Qualification SIP/CIP Controlled-Rate Freezing SOP Authoring Master Batch Records Process Development Data Analysis Statistical Analysis Cleanroom Operations EHS GMP Training Technical Documentation
Certification
- Lean Six Sigma Yellow Belt, 2022, Sigma
- Bi-Literacy in Spanish, 2016, International Baccalaureate
Publications
Strong, Brandon E, Lore, Brittany E, Christensen, Emily R, Martinez, Nathaniel W, Martinez, Andres W, How To Shrink Paper Money: A Macroscopic Demonstration of the Malaprade Reaction., Journal of Chemical Education, 04/19, 1199-1204, 10.1021/acs.jchemed.8b00951
Languages
English
First Language
Timeline
Senior Cell Therapy Manufacturing Specialist
Cellares
12.2024 - 08.2026
Cell Therapy Manufacturing Specialist
Cellares
11.2023 - 12.2024
Manufacturing Associate III
Triumvira Immunologics, Inc.
10.2022 - 10.2023
Bioprocess Manufacturing Associate II
PACT Pharma
03.2021 - 10.2022
Bioprocess Manufacturing Technician
Genentech and U.S. Tech Solutions
07.2020 - 03.2021
Undergraduate Research Assistant
Dr. Andres Martinez
06.2018 - 07.2020
Undergraduate Research Assistant
Dr. Heather Liwanag
03.2017 - 07.2020
Bachelor of Science - Biological Sciences
California Polytechnic State University