Cell Culture Associate - Billerica, MA

Organisation Description
EMD Serono, Inc. is a leader in US biotechnology, focusing on reproductive health, metabolic endocrinology, and neurology. More than 500 people work in the world-class facilities in Rockland, MA, and approximately 250 work in the field.
Description

JOB SUMMARY Responsible for the successful execution of mammalian cell culture processes in the Protein Production Laboratory (PPL), a pilot-scale facility producing high quality Phase I and II clinical grade therapeutic proteins in a cGMP environment. As an upstream team member, scope of work includes cell bank creation, vial thaw & scale-up, bioreactor and clarification unit operations, and process data trending for both pilot engineering runs as well as cGMP campaigns. ESSENTIAL DUTIES AND RESPONSIBILITIES Include, but are not limited to:Conduct upstream unit operations and operate process equipment in accordance with SOPs to maintain cGMP compliance. Author and revise operational documents including batch records, SOPs, and cell bank specifications. Graph and analyze data and author technical reports, present data in group meetings Evaluate in-process test results. Identify and recommend corrective actions as needed. Contribute to operational excellence and continuous improvement initiatives for upstream operations Maintain appropriate inventories of laboratory related materials. Perform general maintenance on all upstream process equipment to ensure proper operation of equipment. Troubleshoot equipment issues and call on outside vendors, as required. Assist in the start up and commissioning of process equipment and support validation activities as needed. Work closely with PPL counterparts in Process Development, Support Services, Purification, Quality Control and Quality Assurance. Based on skills and experience, may train personnel in relevant unit operations.

** This position is located at our Billerica, MA facility
REQUIRED EDUCATION/EXPERIENCE/SKILLS Degree in science or engineering related field with cell culture experience. Proficient in cell culture and aseptic techniques. Possess a thorough knowledge of cGMPs, CIP, and SIP. Strong teamwork, communication, and decision making skills Possess excellent oral and written communication skills. Ability to function in a rapidly changing environment and balance multiple priorities simultaneously