Manufacturing Associate II

Company: Cellipont Bioservices
Location: Poway
Posted on: June 15, 2022

Job Description:

Job Description Job Summary: The Manufacturing Associate is responsible for assisting in the planning and timely execution of manufacturing operations for a cGMP-compliant state-of-the-art cell processing/clinical manufacturing facility with emphasis on primary cell isolation and cell culture in an aseptic processing environment. The Manufacturing Associate is responsible for following the standard practices outlined for the operation of the facility in accordance with the regulatory requirements for the manufacture of materials for our clinical studies, clinical trials and products. Duties/Responsibilities: Assists the operation of a state-of-the-art GMP cell manufacturing plant in accordance with FDA, ISO, Environmental Health & Safety, Human Resources, EMA regulations and other Quality System regulations, as applicable. Ensures production area, processes and procedures are maintained in compliance with internal and external compliance and operating standards. Conduct ancillary activities in support of processing functions, e.g. lab and equipment cleaning and maintenance, inventory management and stocking, preparing shipping/packaging materials, etc. Maintains a strong culture of safety, quality, accountability, cost efficiency, on time delivery and customer service. Ensures facilities are maintained in a continuous state of readiness. Identifies and mitigates risks for the operation and timely brings to the attention of a supervisor. Ensures relevant manufacturing data are captured appropriately and accurately for supporting regulatory filings for clinical trials. Assists with evaluation of raw materials, in-process materials and finished product(s), as needed. Inform Supervisor of equipment needs and supplies required to avoid interruption in processes. Performs other duties as assigned. Required Skills/Abilities: Understanding of GMP and GDP requirements. Strong organizational, interpersonal, written and oral communication skills. Excellent time management and organizational skills, demonstrated ability to manage and prioritize multiple projects and meet deadlines. Experience in a matrixed-reporting environment. Able to demonstrate willingness to problem solve and/or diagnose process/product/equipment problems. Knowledge and understanding of standard operating procedures and accompanying documentation. Ability to work well on teams of various sizes, teams that change often, and ability to work alone when required. Excellent verbal and written communication skills. Excellent organizational skills and attention to detail. Excellent time management skills, with proven ability to meet deadlines. Strong analytical and problem-solving skills. Proficient with Microsoft Office Suite or related software. Education and Experience: Bachelors Degree in biologic or pharmaceutical sciences or bioengineering, with demonstrated technical experience required. 2 years experience in cell manufacturing/commercial biologic drug manufacturing operations in a GMP environment. Physical Requirements: Prolonged periods of standing in clean room and at times, sitting at a desk and working on a computer. Must be able to lift 25 pounds repeatedly, ability to lift up to 50 pounds occasionally. Manual dexterity to evaluate, install, and modify equipment.

Keywords: Cellipont Bioservices, Poway , Manufacturing Associate II, Other , Poway, California