Overview GENERAL SUMMARY OF POSITION: Manufactures, assembles, and labels clinical and commercial biologic products. Operates manual and semi-automatic equipment and automated production equipment. Perform all functions under cGMP guidelines. Responsibilities MAJOR RESPONSIBILITIES: Perform and may supervise manufacturing activities for a variety of clinical and commercial products which may include bioreactor operation, purification, 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 prepares reports Train lower level personnel in manufacturing processes and ensures training records are up to date Serve as department liaison with support departments such as compliance, facilities, engineering and quality groups Review records/documents and ensures 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 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 Perform visual inspection of final product vials Perform additional job related duties as required Qualifications REQUIRED QUALIFICATIONS: Requires a bachelor's degree in a scientific discipline, preferably biology with a minimum 5 years of relevant experience or equivalent Ability to follow instructions precisely , recognize deviations, and recommend corrective action Prior experience in a cGxP regulated environment. Strong working knowledge of CFR 21 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 Possesses 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 Experience in the following areas preferred: aseptic filling, cell culture, purification No travel required, standard work hours may require weekend and off shift hours as required / must be able to lift a minimum of 50 lbs using proper lifting technique Associated topics: fertilize, forklift, fork lift, lawn, management, manufacture, production management, ship, transplant, watering
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