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Biomanufacturing Technician II (Relocation Assistance)

Employer
Resilience
Location
Alachua, FL
Start date
Sep 30, 2022
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Job Details

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:

  • Assist with upstream and downstream related activities including cell culture at small and large scale, cell transfection, media and buffer preparation, and bioreactor and fermenter-based production, chromatography purification, centrifugation and ultracentrifugation, ultrafiltration/ diafiltration, and viral clearance.
  • Assist in drafting Standard Operation Procedures, Change Controls, and Deviations.
  • Properly disinfect and stage materials into production rooms before the production campaigns.
  • Assist with equipment ordering, installation, qualification and routine maintenance.
  • Assist with drafting and reviewing Production batch records and review executed records.
  • Assist in writing raw material specifications. research, source, and order material and lab wares.
  • Assist with change-over cleaning in the manufacturing core and other production areas.
  • Assist 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 Specialist, 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

Preferred Experience, Education & Qualifications

  • High School Diploma/GED and 2+ years in cGMP manufacturing environment
  • Ability to stand for 6 hours in a production suite
  • Ability to gown and gain entry to manufacturing areas
  • Ability to work weekends, including holidays as scheduled

Other Ideal Personal Characteristics:

  • Associate's or Bachelor's Degree - Life Sciences
  • Familiarity with Manufacturing Control Systems (i.e. Delta V, Wonderware)
  • Experience with Monoclonal Antibodies
  • CDMO experience
  • Previous work experience in GMP environment
  • Training experience
  • Experience reviewing and creating controlled documents

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.

Company

Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale. Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives by continuously advancing the science of biopharmaceutical manufacturing and development. For more information, visit www.Resilience.com and follow us on Twitter @IncResilience 

Find Us
Website
Location
9310 Athena Circles
La Jolla
CA
92037
United States
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