Supervisor, Manufacturing

Supervisor, Manufacturing

Kincell Bio engineers cells into therapies. With manufacturing facilities located in Research Triangle Park, NC and Gainesville, FL, Kincell Bio is a contract development and manufacturing organization (CDMO) with the mission to streamline CMC development, apply expertise in analytical and process development and GMP manufacturing, testing and release from early clinical to pivotal studies and product launch. Kincell Bio is focused on supporting innovative companies developing immune cell therapies, including autologous and allogeneic CAR-T, TCR, TILs, Tregs and CAR-NK technologies. We offer challenging career opportunities, competitive benefits, and an environment that recognizes and rewards performance.

Kincell Bio is seeking a highly motivated Supervisor, Manufacturing who will be a key contributor to a dynamic and collaborative Manufacturing team. We offer challenging career opportunities, competitive benefits, and an environment that recognizes and rewards performance.

Essential Duties and Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.

The Supervisor in Cell and Gene Manufacturing will assist in leading GMP manufacturing for Kincell Bio's facility in Gainesville, FL. The Manufacturing team is accountable for building, maintaining, and continuously improving a highly effective cGMP production workforce, driving activity to achieve the desired departmental, site, and company outcomes, and ensuring the highest standards of workplace safety and product qualities. The manufacturing supervisor must adhere to a safety-first, quality-always, department-translatable, mindset. The manufacturing supervisor provides:

• 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.

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.

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.

Management Responsibilities

• Hire, recruit, coach, and train employees within the manufacturing group
• Continuously assess and ensure the appropriate manufacturing structure is in place to support growth. Identify gaps and ensure the proper hiring and development of employees with the support of Human Resources.
• Set expectations, provide feedback and coaching, and take necessary action to ensure appropriate performance and goal attainment.

• GMP Cleaning
• Possible Process Development supporting autoclaving, cleaning, & prep work
• Media and Buffer Prep (GMP) – leverage for Process Development as feasible
• Lab Inventory checks / Kanban
• Small equipment Preventive Maintenance / Calibrations
• 6S Actions
• If applicable, 2nd shift overlap with 1st first shift insuring proper shift hand-off and transfer of critical and key information.

Travel Requirements

• Less than 10%

Location

• This is a 100% site-based temporary position located in Gainesville, FL, and will require some non-standard working hours, including scheduled early mornings, late evenings, and/or weekends.

Kincell Bio provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable, federal, state, and local laws. Kincell Bio complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

NOTE TO EMPLOYMENT AGENCIES: Kincell Bio values our relationships with our Recruitment Partners. We will only accept resumes from those partners who have been contracted by