Job#: 1265124 Job Description: Lead Associate, Bioprocess 1265124Job Scope & Purpose:Our Cambridge/Waltham Biotech client is seeking an experienced Bioprocessing Lead to join their growing team! They are a smaller team and are therefore seeking an individual capable of taking ownership of multiple responsibilities outside of day to day manufacturing operations. They are seeking candidates looking for a fast pace, challenging environment with varied work, and who have the ability to innovate both scientifically and in business processes.This team works closely with the process development, formulation, quality and clinical groups, which will provide a tremendous amount of cross functional experience in a short period of time for the right, driven candidate.Primary Job Responsibilities:
- Manufacturing research, pre-clinical (GLP) and clinical material utilizing single use equipment of various scales.
- Leading day-to-day support for bench and clinical production, including: media/buffer prep, basic maintenance of single use fermentation systems, centrifugation, tangential flow filtration, lyophilization and various pieces of analytical equipment.
- Working directly with vendors/CMO for day to day cleanroom operations, raw material procurement and management, quality systems, and shipment of material to clinical sites
- Problem solving to troubleshoot day to day challenges in order to meet aggressive manufacturing timelines
- Innovating on current processes where applicable in order to add efficiencies and reliability to process execution.
- Aiding in all aspects of process tech transfer from process development, downstream processing and formulation to our manufacturing cleanroom.
- Developing and managing Standard Operating Procedures (SOPs) according to GxP regulations including batch records, and accurately complete documentation associated with preclinical or clinical manufacturing.
- Participating in deviation, CAPA, and change control write-ups facilitating the release and drug product destined for use in clinical studies
- Following GMP protocols in the completion of assigned duties.
- Bachelors degree with 3+ years experience
- Experience and knowledge of activities routinely performed in microbial fermentation (vial thaw, cell culture expansion, bioreactor setup and control, centrifugation, TFF, and media/buffer preparation).
- Working knowledge of regulatory compliance requirements in a cGMP environment is a plus
- Experience with single use bioreactors is a plus
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