Manufacturing Associate at Lancesoft Inc

Title: Biotechnologist Associate Location: Portsmouth, NH - 03801 Duration: 12 Months Nights - 7 PM - 7 AM - rotating days - every other weekend. Description: The Manufacturing Associate is responsible for the manufacturing of therapeutic proteins (API) under cGMP conditions. Associates are expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, perform basic laboratory tasks, including pH, conductivity, sampling, and conduct routine sanitization tasks to maintain facility and equipment. They are expected to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique in handling of products and materials. • Set up, operate equipment, and monitor production processes, including clean-in-place (CIP) and steam-in-place (SIP) operations and report production in written and electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), review documentation as appropriate. • Attain qualification for all assigned tasks and maintain individual training plan. • Perform basic laboratory tasks, such as monitor pH, conductivity, test product samples, etc. • Perform material movements, transfer raw materials, chemicals into, out of, across the production areas. • Maintain facility and equipment through routine cleaning and sanitization, support 6S programs. Must be willing to gown and work in a "clean room" environment. Administrative tasks - attending shift exchange, meetings, sending/receiving emails, participating in projects. • Perform other duties as assigned. Evaluate manufacturing equipment and materials Maintain manufacturing equipment and records Support all areas of manufacturing Maintain rework processes for manufacturing Interpret the current manufacturing documents Remove waste from all manufacturing operations and implement lean manufacturing throughout the facility Create manufacturing aids and shop prints Revise, and approve manufacturing procedures Formulate reagents in a controlled manufacturing environment Provide manufacturing and assembly workmanship and quality standards Provide support with multiple business process systems to support all areas of manufacturing Assist in the introduction of new manufacturing platforms into the GMP manufacturing facility Support the manufacturing floor for any process related questions Assist manufacturing change owner for changes impacting the process Ensure a quality and compliant manufacturing environment Provide all the necessary training required to incorporate new production equipment into the manufacturing facility Assist in the introduction of new manufacturing platforms into the GMP manufacturing facility Analyze and maintain rework processes for manufacturing Reviewing applicants for entry-level manufacturing jobs Provide all the necessary training required to incorporate new production equipment into the manufacturing facility