-
ID
#43844163 -
Job type
Permanent -
Salary
TBD -
Source
Apex Systems -
Date
2022-07-04 -
Deadline
2022-09-02
Lead Associate - Bioprocess
Massachusetts, Cambridge, 02138 Cambridge USAPermanent
Vacancy expired!
- 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
Vacancy expired!
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