Kincell Bio · 19 hours ago
Supervisor, Manufacturing
Gainesville, FL
Full-time
Onsite
Mid, Senior Level
1+ years expKincell Bio is a contract development and manufacturing organization focused on engineering cells into therapies. They are seeking a highly motivated Supervisor, Manufacturing to lead GMP manufacturing operations, ensuring high standards of quality and safety while driving a high-performance culture.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
Direct floor leadership for the manufacturing team and is a key value stream leader for projects providing both technical and operational leadership / expertise
Solve or troubleshoot complex problems
Accountability for floor operations and execution – directly impacting product, patient, and process
The leadership, management, and company vision necessary to ensuring the proper controls, Key Performance Indicators, people, and systems are in place within the manufacturing function
Work with department leadership and team to establish programs, practices, and processes that drive a high-performance culture and engaged workforce across Safety, Quality, Delivery, Cost and People
Escort Vendors / Visitors within MFG Cleanrooms
Lead all day-to-day manufacturing operating activities including but not limited to:
Manufacturing
Manufacturing support
Manufacturing compliance to ensure delivery of departmental commitments, achieving company objectives
Batch Record / Logbook reviews and approvals
Review completion of MBRs; hand off to QA with accuracy / bringing MBRs to complete disposition
Create batch readiness task trackers and schedule MFG operations
Assist in planning, scheduling, and production functions to ensure adequate materials, equipment, and personnel are available to meet the production schedule
Support and Conduct Enrollment of Materials / Bill of Materials
Create purchase requests / procure items as needed
Accountable for encouraging and enforcing a culture of compliance and continuous improvement surrounding Safety, Quality, Delivery, Cost and People
Assist in the development and implementation of Key Performance Indicators to track and lead successful, timely and achievable goals, objectives, and projects
Maintain department operational and capital budgets, responsible for driving financial results, and optimization of fixed and variable costs
Work with internal stakeholders in manufacturing, process development, process sciences, project management, research, and development, etc. to help facilitate successful projects to manufacturing transition and management
Provide leadership, direction and accountability to ensure Inspections, Deviations, Change Control, CAPAs and Regulatory commitments are met on time with the highest standards of quality and the highest standards of area ownership. May be required to author/draft these documents
Author / Draft protocols when needed
Collaborate with team to develop a robust training program/strategy ensuring technician ownership and accountability
Work with team to develop and maintain operational excellence programs, such as 6S, lean manufacturing, and leadership standard work
Collective collaboration & goal setting with all other entities on site including Process Development, Quality Assurance, Quality Control, etc
Make decisions, based on professional judgment, experience, budget, cGMP regulations, and the ethical guidelines of good business practices
Evaluate the functional strengths and developmental continuous improvement opportunities within the GM manufacturing team and surrounding focus areas
Must stay current with relevant technologies and be forward-thinking to identify new approaches and opportunities
Minimum expectation of 40 hours per week, unless otherwise dictated by management or business needs
Able to work the schedule needed to manage operations and complete production documentation and schedule effectively
Use of eye protection, gloves, and other PPE as required
Maintaining aseptic area qualification may be required. This includes aseptic gowning procedures which require all body parts to be covered entirely (gowned) for significant periods of time
Practice and promote a safe work environment at all times
Other duties as assigned
This position may require some non-standard working hours including early mornings or later evenings on weekdays and weekends
Qualification
Required
B.S. in Biology, Biochemistry, Chemistry, Engineering, or related field
1-4 years of hands-on experience in biotechnology/pharmaceutical manufacturing practices, guidelines, management practices, cGMP knowledge, and production and planning operations
Preferred
1-2 years in a Manufacturing/Operations Leadership role and leadership experience in a cGMP environment
Ability to work by positively influencing peers and their reports and gain their cooperation
Ability to see the 'big picture' while being capable of driving detailed and robust results in line with organizational strategy. A high sense of urgency and a commitment to delivering results is highly desirable
Experience in cell gene therapy manufacturing and/or aseptic processing
Benefits
Competitive benefits
Company
Kincell Bio
Kincell Bio collaborates with cell therapy developers by using considerable scientific experience and industry understanding.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$58MKey Investors
Kineticos Ventures
2025-05-15Series Unknown· $22M
2023-07-26Series A· $36M
Leadership Team
Lawrence Pitcher
Chief Executive Officer
Recent News
2026-01-15
Company data provided by crunchbase