Cellares · 5 months ago
Manager, Cell Therapy Manufacturing
South San Francisco, CA
Full-time
Onsite
Senior Level, Lead/Staff
$90K/yr - $210K/yr
8+ years expCellares is an innovative company focused on cell therapy manufacturing, employing an Industry 4.0 approach to mass produce living drugs. They are seeking a Manager for Manufacturing to oversee cGMP operations in their multi-product facility, ensuring safe and compliant production of cell therapy products while leading a team and collaborating across various functions.
BiotechnologyLife ScienceManufacturingMedicalTherapeutics
Responsibilities
Lead, direct, coach, and develop an effective manufacturing team responsible for daily clinical and production of autologous and allogeneic cell therapy products, while ensuring safe and compliant operations according to cGMP requirements
Provide technical and managerial leadership by effectively interfacing and collaborating with key stakeholders and functions across the organization to successfully manufacture and disposition products to patients in a timely manner
Monitor, and improve production metrics related to Safety, Quality, Compliance, Cost, Delivery, and People
Oversee the hiring, development, and performance management of staff within manufacturing
Lead and actively participate in all health authority, customer, and internal audits of the facility
Serve as the Manufacturing Host for audits by leading tours and serving as SME for the facility
Work closely with other functional areas to develop and execute against the strategic plan for the manufacturing site
Establish key stakeholder relationships with internal and external stakeholders
Review in-process and completed documents for accuracy and to make sure batch records are turned in to area management within specified days of completion
Responsible for revising and originating production records, standard operating procedures, protocols and reports
Initiate, investigate, and support the closure of Deviation Reports and CAPAs
Ensure manufacturing processes in both an R&D and GMP environments are following appropriate protocols and/or standard operating procedures (SOPs)
Provide feedback to engineering and process teams, support with requirements gathering and review
Contribute to analysis and presentation of technical results at departmental meetings and with clients
Perform routine clean room and laboratory activities including ordering, cleaning, restocking, and equipment qualification/maintenance
Work with Quality Control, Facilities, Materials Management, Quality Assurance and Validation to complete assignments
Other duties as assigned
Qualification
Required
Bachelor's degree in science, engineering, or related field required
A minimum of 8+ years of operations experience within a cGMP environment in the biotech/biopharma industry with a minimum of 3 years leadership experience
Cell/Gene Therapy experience required, CDMO experience preferred
Experience in tech transfer, process validation, project management, and change management
Previous experience interacting directly with the FDA and other regulatory agencies
Substantial knowledge of Quality Systems, GMP, FDA, GAMP, ISO and other applicable standards
Demonstrated experience in managing GMP manufacturing operations
Demonstrated startup experience or leading organizations through dramatic growth
Ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment
Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members
Develop and build cohesive, high performing teams with a strong sense of mission, providing training and mentoring to build sufficient management depth throughout the organization and ensure strong succession planning
Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability
Excellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels within the organization
Desire to be part of a rapidly evolving organization, with compelling technology, and take products and processes to the next level
Excellent organizational and communication skills
Self-awareness integrity, authenticity, and a growth mindset
Preferred
CDMO experience preferred
Lean Six Sigma certification preferred
Experience with Operational Excellence and/or Lean Manufacturing
Benefits
Highly subsidized Medical, Dental, and Vision Plans
401(k) Matching
Free EV Charging
Onsite lunches
Stock options
Company
Cellares
Cellares is a life sciences technology company that develops the Cell Shuttle to automate cell therapy manufacturing.
51-200 employees
H1B Sponsorship
Cellares 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 (1)
2024 (2)
2023 (2)
2022 (1)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
$355MKey Investors
Koch Disruptive TechnologiesEclipse Ventures
2023-08-23Series C· $255M
2021-05-05Series B· $82M
2020-10-29Series A· $18M
Leadership Team
Fabian Gerlinghaus
Co-Founder & CEO
Omar Kurdi
Co-Founder and President
Recent News
Genetic Engineering News
2026-01-16
Morningstar.com
2026-01-12
Company data provided by crunchbase