Manufacturing Associate I *PC 382

This position is responsible for the manufacture of biologics (LV) under cGMP conditions. Staff must follow established procedures, execute batch production records using good documentation practices, and adhere to gowning procedures required for work in a cleanroom environment.

Responsibilities

• Adhere to clean room Standard Operational Procedures (SOPs) for gowning, traffic flows, and modes of operation.
• Complete successful gowning aseptic processes qualification.
• Follow batch record instructions and complete GMP documentation.
• Responsible for the proper use of production equipment in strict accordance with cGMPs, SOPs, and safety policies.
• Responsible for cleaning of equipment and work areas as required.
• Assist in the revision and review of established documentation (SOPs, BPRs).
• Maintain inventory and restock supplies when needed.
• Complete Purchase Order Requests.

Requirements

• 1 year of GMP experience.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear.
• Required to stand; climb or balance; and stoop, kneel, or crouch.
• Must occasionally lift and/or move up to 50 pounds.
• Specific vision abilities required include close vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
• Must have the ability to handle more than one task at a time and work at a rapid pace while maintaining attention to detail.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

• Performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures.
• Generally performed in a sanitized laboratory setting, routinely using standard medical and research equipment such as centrifuges, biosafety cabinets, chromatography devices, tangential-flow filtration devices, peristaltic pumps, metering fill pumps, pipettes, and computers.
• Frequently exposed to cultured human cells (immortalized, not primary) and lentivirus-derived vector particles.
• Employees must wear appropriate clothing and protective equipment such as scrubs, coveralls, masks, glasses, and gloves when entering and leaving the laboratory.
• The noise level in the work environment is usually moderate.

Pay

The anticipated base salary range is $22.01/hr - $25.91/hr. The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialization, skills, abilities, and training.

Benefits

• Comprehensive benefits package including health, vision, and dental insurance.
• 401(k) plan.
• Certain positions are eligible for additional forms of compensation such as bonuses or commissions.