Senior Biological Technician (Wednesday - Sunday)

Shift: Wednesday - Sunday

Key Responsibilities

Advanced Production & Laboratory Operations

Manufacture biological indicator components in accordance with cGMP procedures, including but not limited to: 

• Spore seeding and inoculation; 

• Agar pour plate preparation and testing; 

• Preparation of sub‑assemblies and raw materials; 

• Harvesting and washing activities; 

• Perform in‑process and release testing, including: 

  • Percent spore determination; 

  • Purity testing; 

  • Titer testing

Equipment, Area, and Process Ownership

• Perform and oversee preventative maintenance and basic troubleshooting of laboratory equipment in accordance with approved SOPs

• Ensure daily area housekeeping and sustained GMP readiness

• Manage routine laboratory processes and ensure required checks and verifications are completed accurately and on time

• Conduct inventory reconciliation, material restocking, and SAP transactions as required

Documentation, Compliance & Investigations

• Prepare, review, and verify batch records and production documentation in accordance with cGDP requirements

• Support investigations, deviations, inspections, and root cause analysis activities as directed

• Ensure personal and team compliance with all Federal, State, local, and Company regulations, policies, and procedures

Technical Leadership & Training

• Train and mentor junior‑level technicians in accordance with approved manufacturing procedures and standard work

• Participate in and actively support process improvement initiatives, including Kaizen, 5S, and efficiency projects

• Communicate operational risks, issues, and improvement opportunities to supervision and management

• Safety, Communication & General Responsibilities

• Support a strong safety culture and ensure proper use of PPE and safe laboratory practices

• For individuals with informal or formal leadership responsibilities, ensure work is performed in compliance with Health, Safety, and Environmental requirements

• Perform other duties as assigned to support business needs

Education and Experience Requirements

• 6+ years of relevant laboratory or biologics manufacturing experience, or 2+ years of experience with a Bachelor’s degree in a related scientific discipline.

• High School Diploma or GED required.

• Bachelor’s Degree in Biology, Microbiology, or a related scientific discipline preferred

• Strong working knowledge of cGMP and cGDP requirements

• Advanced laboratory skills in aseptic processing and biologics manufacturing

• Experience working in an FDA‑regulated manufacturing environment

• Proficiency with SAP or similar inventory management systems

• Basic computer skills (word processing and spreadsheets)

• Yellow Belt certification preferred

• Domestic travel may be required

• Ability to lift 31–50 lbs

• Ability to wear required PPE

• Ability to work in a manufacturing laboratory environment

About Company

Company