Senior Specialist, Manufacturing Execution System
At Lyell, our vision is to develop curative cell-based immunotherapies for solid tumor cancers. We have innovative science originating from our founder’s world class labs and a unique and disruptive approach to research and development. Our company is first and foremost focused on understanding the science. We are a learning organization, dependent on deep collaborative relationships between all of our colleagues, partners and founders. Our culture is based on Science, Respect, Courage and Collaboration and it reflects who we are and the environment we are creating.
The incumbent will be responsible for implementing and supporting the Manufacturing Execution System (MES) and electronic Master Batch Records (MBRs) strategy. This role provides MES system support to Manufacturing, MSAT, Technical Transfer, Quality and Supply Chain to ensure priorities are being addressed in a timely manner to meet the company’s clinical programs timeline.
KEY ROLE AND RESPONSIBILITIES:
- Continue to advance strategy for manufacturing documentation, including standard content and structure for batch records, standard operating procedures, forms, and logbooks.
- 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 appropriate.
- 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 flow.
- Provide MES support for production that includes hours outside of normal business hours.
- 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 processes.
- Configure/update MES to support new clinical programs and change requests.
- Coordinate the review and revisions of procedures, Process Development/Technical Transfer documentation and FDA regulations for inclusion in SOP and quality manuals.
- 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.
- BA/BSc in biology, biochemistry, chemical engineering, bioengineering, or related scientific field with a minimum of 7 years’ experience; or
- MBA or MSc in biology, biochemistry, chemical engineering, bioengineering, or related scientific field with a minimum of 5 years’ experience
- Minimum 6 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.
- Minimum 5 years hands-on experience as a Solution Architect leading digital transformations enabled by Werum MES technology required
- Experience with Process Equipment and Process Automation Systems in MES context. Ability to build interfaces 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.
KNOWLEDGE, SKILLS AND ABILITIES:
- Excellent communication, technical writing, and project management skills.
- 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 skills.
- 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.
At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees.
Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company’s facilities and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.”
We’ve learned from experience that some of the best people don’t always match our requirements perfectly - if you’re interested and think you could fit, please don’t hesitate to apply.