Senior Specialist, Manufacturing

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.

RESILIENCE (National Resilience, Inc.), is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, or military/veteran status or any other characteristics protected by law.

EEO Minorities/Women/Disabled/Veterans

For more information, visit www.resilience.com

Position Summary & Role

This position will assist in 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).

Essential Position Responsibilities:

• Act as a subject matter expert in Upstream or Downstream related activities potentially including adherent and suspension cell culture at small and large scale, cell transfection, media and buffer preparation, bioreactor and fermenter-based production, depth filtration, chromatography purification, centrifugation and ultracentrifugation, ultrafiltration/diafiltration, and viral clearance.

• Work with Tech Transfer and Technical Operations groups for efficient process design and transfer into the cGMP compliant process suites.

• Draft Standard Operation Procedures, Work Instructions, Change Controls, and Deviations, and other controlled documentation.

• Interface with Validation and Calibration engineering teams for startup, testing, and operation of Manufacturing equipment

• Properly disinfect and stage materials and equipment into production rooms before the production campaigns.

• Order equipment and perform installation, qualification, and routine maintenance. Interfaces, schedules, and performs on-site monitoring of outside services of all Manufacturing equipment.

• Draft and collaborate on Production batch records and review executed records.

• Write raw material specifications. research, source, and order material and lab wares.

• Lead activities to support production campaign such as preparation of tubing assemblies, autoclaving, material request, and material transfer into production rooms.

• 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 Educational Requirements for Competency: (Please attach the copy of any degree, certificate, training as necessary)

• Possess a B.S. (Biology, Microbiology, Chemistry or equivalent) and minimum 5 years of manufacturing experience. High School diploma, GED, or A.S. degree and 8 years of relevant work experience may substitute.

• 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.

• 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

• Must have intermediate to advanced computer skills and be proficient 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

Physical Demands

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 wok 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 excess of 20 pounds of force constantly to move objects.

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 following visual activity requirements:

Preparing an 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 with 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 service, general laborer, etc.) or to make general observation of facilities or structures (i.e.… security guard, inspection, etc.)

Work Environment

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

Temperature changes

Activities occur inside and outside

Temperatures above 100 degrees for periods of more than one hour

Outside environmental conditions

Temperatures typically below 32 degrees for more than one hour

This job requires exposure to the following:

Noise (enough noise to cause the employee to shout in order 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.)

Close quarters: crawl spaces, shafts, man holes, 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.