Specialist, Biomanufacturing

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.

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Position Summary & Role

Perform 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/defiltration, 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 Job Qualifications:

• Experience with downstream-related activities in the biotech industry or cGMP environment
• Ability to document work clearly and accurately and be detail oriented.
• Intermediate to advanced computer skills and be proficient with Word and Excel.
• English reading comprehension and legible writing skills.
• Self-motivated and hard working.

Preferred Job Qualifications:

• Possess a B.S. (Biology, Microbiology, Chemistry or equivalent) and 0-2 years of manufacturing experience or High School diploma, GED, or A.S. degree and 4 years of relevant work experience may substitute
• Communication and organization skills in a teamwork environment.
• Experience working as a team member with shared responsibilities.
• Previous work experience in cGMP environment.

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 can include respirators, Personal Air Purifying Respirators (PAPR), gowns, gloves, face protection, other barrier equipment, etc.

* Noise exposure of over 85 decibels (enough noise to shout to be heard above ambient noise level).

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.