Specialist II, Manufacturing (Night Shift - 12-Hour Shifts)

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

This position will assist in production related activities such as room cleaning, buffer/media preparation, upstream, downstream, drug product and manufacturing-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.

**This is a Night Shift position - 12-hour shifts**
Shift Schedule:

- Wed/Thur/Fri/Sat

- Thur/Fri/Sat

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.

• Generate and review GMP production related documentation such as Production Batch Records, label templates, Standard Operation Procedures, Change Controls, Deviations, CAPAs, etc.

• Prepare training material and train team members, colleagues, etc.

• Supports Validation, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipment

• 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

• 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.

• Thorough understanding of operations in vaccine and/or biologics manufacturing and aseptic techniques.

• Adhere to safe working practices.

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

• Supports other cross-functional teams as necessary to achieve Manufacturing team goals

*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 working in a cGMP environment within a pharmaceuticals/biotechnology organization

• Self-motivated and hard working

• English reading comprehension and legible writing skills.

• Must have intermediate to advanced computer skills and be proficient with Word and Excel.

• Ability to document work clearly and accurately and be detail-oriented.

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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).

• Must have intermediate to advanced computer skills and be proficient with Word and Excel.

• Experience working as a team member with shared responsibilities is desired.

• Communication and organization skills in a teamwork environment.

• Experience working as a manufacturing operator in biologics or vaccine manufacturing oper