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GENERAL SUMMARY OF POSITION:

The Manufacturing Associate III is responsible for manufacturing, assembling, and labeling of clinical and commercial biologic products. Operates manual and semi automatic and automated production equipment. Performs all functions under cGMP guidelines.

MAJOR RESPONSIBILITIES:

• Perform and may supervise manufacturing activities for a variety of clinical and commercial products through unit operations which may include upstream process, harvest process, downstream process, bulk drug formulation and filtration, drug product fill finish, 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 lower level personnel in manufacturing processes and ensure training records are up to date.
• Serve as department liaison with support departments such as compliance, facilities, engineering and quality group.
• Review records/documents and ensure compliance with cGMPs.
• Write SOPs, batch records, technical reports and other cGMP documents as required.
• Ensure media, glassware and other required items are ready for production.
• Participate in incident deviations and remediation.
• Propose production schedules to meet production needs and coordinate schedules during shut-down periods.
• Make recommendations in improving and streamlining production operations.
• Manage on-site inventory for day to day operations.
• Perform visual inspection of final product vials.
• Performs additional job related duties as required.

REQUIRED QUALIFICATIONS:

• Requires a bachelor’s degree in a scientific discipline, preferably biology
• Minimum of 5-7 years of relevant experience.
• Ability to follow instructions precisely, recognize deviations, and recommend corrective action.
• Prior experience in a cGxP 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.
• Strong critical thinking, time management and organizational skills. Demonstrated ability to multitask and consistently meet deadlines.
• Possess well developed attention to detail, ability to maintain accurate records and excellent proofreading skills.
• 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.
• Experience in the following areas is required: aseptic manufacturing.
• Must be able to lift 50 lbs. minimum using proper lifting technique
• No travel required, standard work hours may require weekend and off shift hours as required