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GENERAL SUMMARY OF POSITION: 

The Manufacturing Associate IV is responsible for manufacturing, assembling, and labeling of clinical and commercial biologic products. Operate manual, semi-automated and automated production equipment. Perform all functions under cGMP guidelines.

MAJOR RESPONSIBILITIES:

• Perform and may supervise manufacturing activities for a variety of clinical and commercial products which may include cell banking, bioreactor operation, purification, visual inspection, filling, packaging, and labeling
• Perform manufacturing activities of licensed and clinical products in an aseptic environment
• Perform autoclaving, cleaning and sterilization operations as needed
• Ensure maintenance of records and logbooks
• Tabulate data and prepare reports
• Train personnel in manufacturing processes and ensure training records are up-to-date
• Serve as liaison with other departments such as compliance, facilities, engineering, supply chain, and process development and quality groups
• Executes and reviews records/documents and ensures compliance with cGMPs
• Write SOPs, batch records, technical reports and other cGMP documents as required
• Ensure media, glassware, equipment and other required items are ready for production
• Participates in incident deviations and remediation
• Propose production schedules to meet production needs and coordinates schedules during shut-down periods
• Make recommendations in improving and streamlining production operations
• Manage on-site inventory for day to day operations
• Troubleshoot procedures and equipment. Collaborates with Mfg. Compliance to conduct root cause investigations of problematic manufacturing runs and makes recommendations to improve runs
• Takes an active role in the organizational aspects of the Manufacturing department such as ordering and equipment repair
• When required hires, manages and trains staff, plans and assigns duties to meet departmental and organizational objectives. Provides guidance and direction to staff; establishing expectations, defining roles, supporting career development and managing performance
• Perform additional job related duties as required

REQUIRED QUALIFICATIONS:

• Bachelor's degree in a scientific discipline, preferably biology, or equivalent experience
• Minimum 7-9 years of relevant experience or equivalent
• Experience in the following areas is required: aseptic manufacturing
• Ability to follow instructions precisely, recognize deviations, and recommend corrective action
• Prior experience in a cGxP cGMP regulated environment. Strong working knowledge of 21CFR
• Demonstrated ability to train and supervise others
• Ability to conduct complex troubleshooting
• Computer literate and proficient in MS Word, Excel and other relevant electronic systems meet deadlines
• Excellent written and verbal communication skills. Ability to communicate effectively (up, down, and laterally) with others
• Demonstrated initiative through past experience
• Ability to work effectively both independently and as a member of a team

PREFERRED QUALIFICATIONS:

• Experience in the following areas preferred: aseptic filling, cell culture, purification