Supervisor, Manufacturing

A career at Resilience is more than just a job - it's an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

Position Summary & Role

The Supervisor, Manufacturing will perform and lead production related activities in the cGMP Manufacturing Core according to established procedures at the Advanced Development and Manufacturing Facility in Alachua (Florida) and accompanying Area G Manufacturing Facility.

Essential Position Responsibilities

• Work environment also includes office space for administrative work, document preparation/review and access to electronic Operation and Quality Systems.
• This position will perform and lead production related activities in the cGMP Manufacturing Core of the Advanced Development and Manufacturing (ADM) Facility as well as the expanded Area G Facility in Alachua (Florida).
• Lead manufacturing related activities (e.g. upstream, downstream, cell banking, etc.) including cell culture at small and large scale, cell transfection, media and buffer preparation, and bioreactor and fermenter-based production.
• Lead and perform production related activities activities including operations of incubators, biosafety cabinets, Wave bioreactors, single-use bioreactors, stainless steel bacterial fermenters, depth filtration skids, TFF skids, centrifugation, chromatography purification, single-use mixers, and in process testing equipment.
• Establish goals, performance standards, and performance management for manufacturing staff.
• Thorough understanding of operations in vaccine and/or biologics manufacturing and aseptic techniques.
• Ensure schedule adherence with Supply Chain requirements, coordinating with cross-functional teams (e.g., Quality Assurance/Quality Control, Production Planning & Inventory Control, Regulatory, etc.) to meet production goals.
• Prepare training material and train team members, colleagues, etc.
• Generate and review GMP production related documentation such as Production Batch Records, label templates, Standard Operation Procedures, Change Controls, Deviations, CAPAs, etc.
• Order equipment and assist in installation, qualification, and routine maintenance.
• Staff resourcing, hiring, and onboarding
• Resolve problems of manufacturing staff and manages manufacturing resources
• Prepares and conducts technical presentations of manufacturing processes
• Works with subject matter experts to trouble-shoot and/or optimize processes as required
• Supports the technical transfer of new products into the manufacturing area
• Supports Validation, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipment
• Supports QA during audits and regulatory inspections
• Supports other cross-functional teams as necessary to achieve Manufacturing team goals
• Approve timecards, personal time off requests, and coordinate scheduling of direct reports for proper shift staffing
• Conduct mid-year and end of year employee reviews for direct reports.
• Create and guide direct reports using Performance Improvement Plans, if necessary.
• Adhere to safe working practices.
• Provide other support as assigned by Management.
• This position will support the Wednesday - Saturday schedule on a 12-hour day shift

Adhere to safe working practices.

• Provide other assistance as needed to the Manufacturing Supervisors, and Managers

*All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role

Minimum Qualifications

• Experience in team leadership responsibilities, within a cGMP environment
• Ability to document work clearly and accurately and be detail oriented.
• Must have intermediate to advanced computer skills and be proficient with Word and Excel.
• English reading comprehension and legible writing skills.
• Technical writing skills
• Communication and organization skills in a teamwork environment.
• Self-motivated and hard working

Preferred Qualifications

• A post-secondary degree from an accredited institution with a major field of study in Biology, Chemistry, Engineering or similar may substitute for the required experience (for example, an A.S and 6 years of experience, B.S. and 4 years of experience, M.S. and 2 years of experience).
• Experience working as a manufacturing supervisor in biologics or vaccine manufacturing operations.
• Experience with regulated systems to perform job duties (i.e. SAP/MES, QAD, Veeva, QMTS, LMS, LIMS, Maximo/Procal, Trackwise, etc.)

Role/Site Specific Requirements

This position may also include the following:

• This role is primarily a non-sedentary role. This can include climbing, kneeling, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects.
• Visual acuity such as: working with data & figures, viewing computer terminals, extensive reading, operating machinery, operating motor vehicles, general observations of facilities, etc.

Exposure to the following:

• Moving mechanical parts, electrical current, working on high places, exposure to high heat or exposure to chemicals.
• Handling, managing, disposing hazardous and non-hazardous waste (which can include chemicals, universal and e-wastes, oil, aqueous wastewater, etc.), inclusive of exposure to bloodborne pathogens.
• Working in BSL-2/3 laboratories & production rooms, waste holding areas, or other facilities where biological hazards and hazardous chemicals may be stored or handled.
• Conditions that affect the respiratory system or the skin: fumes, odors, dust, mists, gases, or poor ventilation.
• Close quarters, narrow passageways, crawl spaces, shafts, manholes, small, enclosed rooms, small sewage, and line pipes.
• Use of personal protective equipment (which requires the use of equipment such as middle or full-face respirators, Personal Air Purifying Respirators (PAPR), gowns, gloves, face protection, other barrier equipment, etc.)
• Participation in an occupational health program (which requires to participate in medical assessment, surveillance, vaccination, and testing, etc.)
• Noise exposure of over 85 decibels (enough noise to shout to be heard above ambient noise level).
• 12-hour shift

Exposure to the following:

• Handling, managing, disposing hazardous and non-hazardous waste (which can include: chemicals, universal and e-wastes, oil, aqueous wastewater, etc.), inclusive of exposure to bloodborne pathogens
• Working in BSL-2/3 laboratories & production rooms, waste holding areas, or other facilities where biological hazards and hazardous chemicals may be stored or handled.
• Conditions that affect the respiratory system or the skin: fumes, odors, dust, mists, gases, or poor ventilation.
• Use of personal protective equipment (which include respirators, Personal Air Purifying Respirators (PAPR), gowns, gloves, face protection, other barrier equipment, etc.

The items described here are representative of those that must be met to successfully perform the essential functions of this job.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.