Manufacturing Associate II - Swing Shift PC

Your Role:

This position is responsible for 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 cleanroom environment. Supports training new hires, trouble shooting, preparation of controlled documentation and other Manufacturing duties.

• Adhere to clean room Standard Operational Procedures (SOPs) for gowning, traffic flows, modes of operation.
• Complete successful gowning aseptic processes qualification.
• Follow batch record instruction and complete GMP documentation, review same for completeness and accuracy.
• Draft Change Controls, Investigations and Deviations as required.
• Contribute to the development, writing, and review of Standard Operating Procedures (SOPs), Material Specifications (MSs), Standard Manufacturing Procedures (SMPs), Batch Production Records (BPRs) and other GMP documentation.
• Responsible for the proper maintenance and use of production equipment in strict accordance with cGMPs, SOPs and safety policies.
• Responsible for cleaning of equipment and work areas as required.
• Insure and maintain inventory and restock supplies when needed.
• Complete Purchase Order Requests.
• Assist in troubleshooting processing issues, support investigation and establishing root cause and resolution/corrective action.
• Follow manufacturing schedules, ensuring adequate supplies and equipment are available and released for use.
• Participate in calibration and validation activities as needed.
• Keep supervisor informed of issues.
• Help train new staff as needed.

• Bachelor’s degree (B.S.) from a four-year college or university and at least 2 years of related experience.
• Previous GMP experience is desired, as is good aseptic technique.
• Able to work a Swing Shift schedule:
  Monday – Friday (1pm-9:30pm) with occasional overtime on weekdays & weekends.

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. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel;

reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a sanitized laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, chromatography devices and columns, tangential-flow filtration devices and filters, peristaltic pumps and metering fill pumps, pipettes and computers.

While performing the duties of this job, the employee is frequently exposed to cultured human cells (immortalized, not primary) and lentivirus-derived vector particles. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment such as scrubs, coveralls, masks, glasses and…