About the roleAs a Senior Manager, Analytical Operations, you will report to the Senior Director, Analytical Development and Quality Control. You will lead the execution of routine analytical testing while overseeing the day-to-day operations of the Analytical Operations laboratory. In this role, you will partner closely with Analytical Development, Process Development/MSAT, Research, and Site Operations to support laboratory buildout and expansion, ensure timely delivery of high-quality data, and drive operational excellence. You will also play a key role in building and developing a high-performing team.
What you'll do- Collaborate with Analytical Development and Site Operations to support laboratory buildout, maintenance, and expansion, including budgeting for reagents, consumables, and capital equipment
- Oversee equipment installation, qualification, troubleshooting, and lifecycle management (calibration and maintenance)
- Plan, schedule, and execute routine analytical testing to meet turnaround time requirements for Process Development/MSAT and Research teams
- Ensure accurate and complete documentation of testing activities in electronic laboratory notebooks
- Develop and monitor operational metrics to identify inefficiencies and drive continuous improvement in laboratory workflows
- Implement semi-automated or automated solutions for assay performance monitoring and control trending
- Lead and develop team members through regular feedback, coaching, and performance management
- Influence cross-functional stakeholders and effectively prioritize multiple projects in a fast-paced environment
- Promote a culture of scientific rigor, accountability, and continuous improvement
- Contribute to hiring efforts and build a high-performing, collaborative team
What we're looking for- Bachelor's degree with 7+ years of relevant experience, or an equivalent combination of education and experience
- Experience in cell therapy or a related field
- Strong background in analytical testing, including flow cytometry and cell-based assays
- Experience using tools for assay performance monitoring and data trending
- Demonstrated experience managing direct reports and supporting career development
- Highly collaborative team player, with experience interfacing between Analytical Development, Process Development, and/or Research
- Working knowledge of regulatory requirements and quality standards (e.g. FDA, ICH, and USP/EP)
What will separate you from the crowd- Experience leading digital or laboratory automation initiatives
- Experience working in a regulated, quality-driven environment
- Hands-on experience supporting laboratory investigations and audits in a GMP setting
- Experience with pluripotent stem cells and differentiation
What you should know- Occasional off-hours or weekend work may be required
- There may be potential exposure to BSL2 biohazard materials
- Physical Demands: You may be required to perform the following physical activities: standing, walking, and sitting for extended periods of time; frequent use of the hands, fingers, wrist, and greater arm to handle small materials, tools, boxes, and trays; lifting and carrying objects up to 10 Ibs; occasional overhead reaches and lifts; occasional lifts and reaches below the knee; occasional pushing and pulling of materials and objects with moderate forces; occasional crouching/kneeling, twisting, and squatting movements.
- The base pay range for this position at commencement of employment is expected to be between $160,000 and $200,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience
How we work together for patients- Lead from every seat - we seek to understand, act with honesty, and engage in the crucial conversations
- Thrive as a team - we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity
- Make it happen - we value vigorous debate, alignment around our decisions, and resilient execution
