Manufacturing Associate II

Overview:

Responsible for manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).

Responsibilities:

• Understands aseptic technique concepts

• Has performed aseptic technique, is able to identify unacceptable practices and make spot corrections to performance

• Able to operate and maintain equipment

• Understands the basic operations and functions of equipment and is able to perform basic troubleshooting

• Performs solution and material preparation

• Possesses basic technical knowledge and background in the industry

• Possesses basic and fundamental engineering and mechanical knowledge

• Possesses basic and fundamental facility start-up experience

• Has participated in facility start-ups

• Participates on and performs technical transfer activities

• Assists with the execution of validation activities

• Receives and organizes materials

• Performs material procurement activities

• Identifies, communicates and resolves material discrepancies

• Uses most support systems (e.g. LIMS) with some demonstrated proficiency

• Understands the concept of and has performed or experience with manufacturing processes and methods

• Identifies and understands acceptable and unacceptable practices and is able to make on the spot corrections to performance

• Collects, records, reviews, performs basic analysis and identify basic trends of scientific and process data per good document practices

• Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) and starts to understand ‘why’ behind the regulations

• Follows and executes Standard Operating Procedures (SOPs)

• Revises and authors simple SOPs

• Follows and executes Batch Records (BRs)

• Revises and authors simple BRs

• Trains others on basic SOPs, equipment and unit operations

• Participates and provides information in the development of technical documents such as non-conforming events and deviations

• Possess basic computer skills and able to efficiently use basic Microsoft applications

• Suggests and participates in continuous improvement ideas

• Identifies, participates and suggests solutions to technical problems

• Identifies, suggests and seeks out for decision making

• Participates and supports regulatory inspections and client audits

• Interacts on a minimal basis with groups that support manufacturing

• Cross trains in other areas and may be utilized to perform above job functions across the entire site

• Performs well under direct supervision and starts to work independently on basic tasks and processes

Job Type: Contract

Pay: From $26.00 per hour

Schedule:

• 10 hour shift
• 12 hour shift
• 8 hour shift
• Day shift
• Monday to Friday

Education:

• High school or equivalent (Preferred)

Experience:

• Mammalian cell culture: 1 year (Preferred)
• Cell culture: 1 year (Preferred)
• Aseptic technique: 1 year (Preferred)
• GMP: 1 year (Preferred)

Work Location: In person