Manager, Manufacturing

General Company Description

RESILIENCE (National Resilience, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives.

For more information, visit www.resilience.com .

Position Summary & Role (general description of the role; e.g. expectations, key milestones, impact)

Work hours are 8 hours per day, Monday through Friday. However, depending on production activities, although rare, overtime in the evening and/or weekends and holidays work may occur - predominantly in the manufacturing core in classified cleanroom environment. May also be required to work at times in a range of environments including regular laboratories areas. Work environment also includes office space for administrative work, document preparation/review and access to electronic Operation and Quality Systems.

Job Responsibilities (core responsibilities; include people management if applicable)

• This position will perform and lead production related activities in the cGMP Manufacturing Core according to established procedures at the Medical Counter Measures (MCMs) Advanced Development and Manufacturing Facility in Alachua (Florida).
• Lead upstream/ downstream related activities including cell culture at small and large scale, cell transfection, media and buffer preparation, and bioreactor and fermenter-based production.
• Lead upstream/ downstream related activities including incubators, wave reactors, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, centrifugation and ultracentrifugation single-use mixers, in process testing equipment , , and viral clearance.
• Establishes performance standards and goals for manufacturing supervisors and associates.
• Draft Standard Operation Procedures, Change Controls, and Deviations.
• Draft and review Production batch records and review executed records. Order equipment and perform installation, qualification, and routine maintenance.
• Resolves 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 Ology QA during audits and regulatory inspections
• Supports other manufacturing process teams and other Ology groups as necessary to achieve Manufacturing team goals

• Approve timecards, personal time off requests, and coordinate scheduling of direct reports for on-time delivery of manufactured products.
• Conduct mid-year and end of year employee reviews for direct reports.
• Create and guide direct reports using Performance Improvement Plans, if necessary.
• Hirers, evaluates, train develop, and terminate staff.
• Adhere to safe working practices.
• Provide other assistance as needed to upper Management.

Preferred Experience, Education & Qualifications (Education/Degrees/Certifications)

• Possess a B.S. (Biology, Microbiology, Chemistry or equivalent) or A.S diploma and a minimum of twelve years of manufacturing or lab work experience. High School diploma or GED and years of relevant work experience may substitute.
• 2 years of team leadership responsibilities preferably in a cGMP environment.
• Ability to document work clearly and accurately and be detail oriented.
• Must have basic computer skills and familiar with Word and Excel.
• English reading comprehension and legible writing skills.
• Communication and organization skills in a teamwork environment.
• Experience working as a team member with shared responsibilities is desired.
• Previous work experience in GMP environment is preferred.
• Self-motivated and hard working

Other Ideal Personal Characteristics:

Physical Requirements: (delete rows or statements that are not required to perform the duties of the position)

This job requires the employee to perform the following physical activities:

• Climbing
• Balancing
• Fingering
• Stooping
• Kneeling
• Repetitive motion
• Crouching
• Crawling
• Feeling
• Reaching
• Standing
• Grasping
• Walking
• Pushing
• Hearing
• Pulling
• Lifting
• Talking

This job requires the employee to work in the following conditions:

• Temperature changes
• Activities occur inside and outside
• Temperatures above 100 degrees Fahrenheit for periods of more than one hour
• Outside environment conditions
• Temperatures typically below 32 degrees Fahrenheit for more than one hour

This job requires exposure to the following:

• Noise (enough noise to cause the employee to shout to be heard above ambient noise level.)
• Hazards: moving mechanical parts, electrical current, working on high places, exposure to high heat or exposure to chemicals).
• Hazards: packaging, shipping, handling, or decontamination of blood or other potentially infectious materials (OPIM), including continuous human cell lines.
• Hazards: packaging, shipping, handling, or decontamination of infectious agents assigned to risk group 2, including for emergency response.
• Hazards: packaging, shipping, handling, or decontamination of infectious agents assigned to risk group 3, including for emergency response.
• Laboratories, production rooms, waste holding areas, or other facilities where infectious agents are or may be handled or stored.
• Close quarters, crawl spaces, shafts, manholes, small enclosed rooms, small sewage and line pipes.
• Physical vibration.
• Conditions that affect the respiratory system or the skin: fumes, odors, dust, mists, gases, or poor ventilation.
• Narrow aisles or passageways.

This job requires the employee to perform the following type of physical work:

• Sedentary work . Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
• Light work . Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the employee sits most of the time, the job is rated for light work.
• Medium work . Exerting up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects
• Heavy work . Exerting up to 100 pounds of force occasionally, and/or up to 50 pounds of force frequently, and/or up to 20 pounds of force constantly to move objects.
• Very heavy work . Exerting in excess of 100 pounds of force occasionally, and/or in excess of 50 pounds of force frequently, and/or in excess of 20 pounds of force constantly to move objects.

This job requires the following visual acuity requirements:

• Preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes.
• Operates machines, such as lathes, drill presses, power saws, and mills where the seeing job is at or within arm's reach; performs mechanical or skilled trades tasks of a non-repetitive nature, such as carpenter, technicians, service people, plumbers, painters, mechanics, etc.
• Operates motor vehicles and/or heavy equipment.
• Determines the accuracy, neatness, and thoroughness of the work assigned (i.e., custodial, food services, general laborer, etc.) or to make general observations of facilities or structures (i.e., security guard, inspection, etc.).

This job requires routine or periodic use of respiratory protection:

• Loose-fitting respirators, such as hood or helmet style Personal Air Purifying Respirators (PAPR).
• Tight-fitting respirators, such as half-masks or full facepieces which must seal to the face or neck.