Lyell Immunopharma · 6 hours ago
Specialist, Manufacturing Execution System
South San Francisco, California, United States
Full-time
Onsite
Mid, Senior Level
$108K/yr - $120K/yr
3+ years expLyell Immunopharma is a clinical-stage company focused on advancing next-generation CAR T-cell therapies. The Specialist in Manufacturing Execution System will be responsible for implementing and supporting the MES and electronic Master Batch Records strategy while ensuring compliance with regulatory requirements and supporting manufacturing operations.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Continue to advance strategy for manufacturing documentation, including standard content and structure for batch records, standard operating procedures, forms, and
Lead cross functional teams to develop manufacturing batch records, recipes, workflows, and standard operating procedures, ensuring that operational data, configurations, processes and reports meet all regulatory requirements
Support the system owner to lead and provide support in the design, development, and qualification of manufacturing execution systems
Ensure data integrity of various shop floor electronic systems utilizing MES where
Support the roll out of MES software by creating relevant documentation, end user training and managing user accounts
Collaborate with internal business partners on priorities, timelines and transparent sharing of information
Design, implement, and test MES based on the Business process
Provide MES support for production that includes hours outside of normal business
Implement and maintain LIMS interactions and calculations, QMS for deviation generation during the process, and interface with ERP system to issue materials to MBRs that are acceptable & released
Support the development and optimization of manufacturing
Configure/update MES to support new clinical programs and change
Coordinate the review and revisions of procedures, Process Development/Technical Transfer documentation and FDA regulations for inclusion in SOP and quality
Responsible for ensuring compliance with Federal, State and local regulations and alignment to company policies and procedures relating to GMP's, Health, Safety & Environmental Protection
Qualification
Required
Implementing and supporting the Manufacturing Execution System (MES) and electronic Master Batch Records (MBRs) strategy
Providing MES system support to Manufacturing, MSAT, Technical Transfer, Quality and Supply Chain
Advancing strategy for manufacturing documentation, including standard content and structure for batch records, standard operating procedures, forms
Leading cross functional teams to develop manufacturing batch records, recipes, workflows, and standard operating procedures
Ensuring that operational data, configurations, processes and reports meet all regulatory requirements
Supporting the system owner to lead and provide support in the design, development, and qualification of manufacturing execution systems
Ensuring data integrity of various shop floor electronic systems utilizing MES
Supporting the roll out of MES software by creating relevant documentation, end user training and managing user accounts
Collaborating with internal business partners on priorities, timelines and transparent sharing of information
Designing, implementing, and testing MES based on the Business process
Providing MES support for production that includes hours outside of normal business
Implementing and maintaining LIMS interactions and calculations, QMS for deviation generation during the process, and interface with ERP system to issue materials to MBRs that are acceptable & released
Supporting the development and optimization of manufacturing
Configuring/updating MES to support new clinical programs and change
Coordinating the review and revisions of procedures, Process Development/Technical Transfer documentation and FDA regulations for inclusion in SOP and quality
Ensuring compliance with Federal, State and local regulations and alignment to company policies and procedures relating to GMP's, Health, Safety & Environmental Protection
Preferred
BA/BSc in biology, biochemistry, chemical engineering, bioengineering, or related scientific field with a minimum of 5 years' experience; or MBA or MSc in biology, biochemistry, chemical engineering, bioengineering, or related scientific field with a minimum of 3 years' experience
Minimum 2 years' experience in GMP manufacturing and operations experience with emphasis on MES deployment
Experience in Manufacturing Execution Systems primarily in having designed and created best practice MBRs
Experience with Process Equipment and Process Automation Systems in MES context. Ability to support interfaces builds for plant equipment
Experience in cell therapy or biologics manufacturing unit operations such as cell processing, aseptic processing, fill/finish
Demonstrated experience implementing software systems and performing tasks in a regulated or pharmaceutical production environment
Excellent communication, technical writing, and project management
Deep Master Batch Record and manufacturing document design expertise demonstrated with formal training and experience
Core Computer IT Skills and capability to learn advanced IT
Thorough understanding of Master Data in MES Context, ability to define and manage master data working with a cross-functional team from Manufacturing, Quality, and Supply Chain
Understanding of ERP, LIMS, data historian, and other common manufacturing-related IT Systems and integration requirements with MES systems is highly preferred
Benefits
Subsidized medical, dental and vision plans from your first day of employment
FSA
Company provided Life and AD&D Insurance
STD and LTD Insurance
ESPP
A 401(k) Plan with Company match
Mass transit commuter benefits
Cell phone reimbursement
Range of supplemental benefits that you may choose to elect
18 days’ vacation
9 day’s sick leave
8 observed holidays
Floating holiday
Summer and a winter office shutdown
Company
Lyell Immunopharma
Lyell Immunopharma is an operator of a biotechnology company that develops cellular therapies to cure cancer.
201-500 employees
H1B Sponsorship
Lyell Immunopharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (2)
2023 (2)
2022 (5)
2021 (2)
2020 (3)
Funding
Current Stage
Public CompanyTotal Funding
$543M2025-07-25Post Ipo Equity· $50M
2021-06-16IPO
2020-03-12Series C· $493M
Leadership Team
Lynn Seely
President & Chief Executive Officer
V
Veronica Bulis
Vice President and Corporate Controller
Recent News
2025-12-25
2025-12-19
2025-12-09
Company data provided by crunchbase