Manufacturing Technician I

This is an entry-level position in a cGMP biomanufacturing setting.

The employee is responsible for the commercial production of drug intermediates (protein purification, buffer/equipment preparation), intended for further manufacture of drug products.

Strong emphasis is placed on adherence to Good Manufacturing Practices and the importance of being in compliance with Standard Operating Procedures and Good Documentation Practices.

SPECIFIC POSITION DUTIES (RESPONSIBILITIES, TASKS, ESSENTIAL FUNCTIONS)

• Operates & monitors production equipment under management/senior operator supervision, in accordance to procedures/batch records; including process tanks, balances, bioburden filtration assemblies, chromatography columns/skids, UF/DF equipment, data recorders and depth filter systems

• Weights and measures raw materials, and prepares buffer solutions for use in bulk manufacturing.

• Performs equipment/sanitary parts CIP/COP (Clean In Place/Clean out of Place) and assists with production equipment maintenance, assembly and disassembly.

• Performs aseptic operations including equipment/in-process sampling and work in Laminar Flow Hoods/Biosafety Cabinets

• Disinfects/cleans cleanroom/facility and maintains plant consumable/inventory levels.

• Operates & standardizes analytical instruments including pH meters, conductivity meters, flow meters, spectrophotometers, integrity testers in accordance to Standard Operating Procedures (SOP's).

• Completes production records and documentation with strict adherence to Good Manufacturing Practices (cGMP's) and Good Documentation Practices. Maintains equipment logbooks, reviews & files documentation

• Performs physical tasks associated with bulk manufacturing in a safe & accurate manner.

• Exercises proper cleanroom gowning and cleanroom conduct.

• Demonstrates the ability to work on assigned projects independently with minimal supervision.

• Prepares facility/equipment and consumables based on established schedules.

• Executes facility inspection walkthroughs and communicates safety/contamination/repair issues/needs.

• Projects/development opportunities are provided based on employee development goals.

Requires a high school diploma, GED, or better with a minimum of 1-2 years experience in a cGMP biologics manufacturing facility.

Associates degree or higher with a minimum of 1 year experience in a cGMP biologics manufacturing facility.

Biomanufacturing Certificate/Related College Degree with 0-1 years of experience.

Ability to lift ~50 lbs, approved to wear a respirator for short durations, work in a cleanroom environment (full/sterile gowning), and work in a small, matrix management team situation.

The shift structure consists of four (4) 10 hour days, and a 3-day weekend, with occasional overtime/mandatory overtime.