The Microbiology Manufacturing Associate will perform day to day production of reagents at our Lexington manufacturing facility. This position is responsible for executing manufacturing protocols and providing floor leadership during production shifts. The Senior Associate is a key contributor to executing testing, verification and validation protocols.
RESPONSIBILITIES:
- Follow industry compliance standards (cGMP, FDA, ISO) for the production of external controls and other cGMP products.
- Execute validation protocols for reagent manufacturing processes.
- Identify potential process improvements for reagent manufacturing processes.
- Aid in execution of technology transfer plans for new products transitioning from Product Development to Manufacturing.
- Aid in troubleshooting technical issues.
- Support implementation of new manufacturing equipment and processes including execution of process capability studies
- Assist in executing the IQ, OQ and PQ of equipment.
- Support/manage sustaining activities and drive cost reduction.
- Daily manufacturing activities to meet organizational deliverables.
Required Skills
- Strong aseptic technique.
- Excellent organizational, record-keeping and communication (verbal and written) skills.
- Strong work ethic to generate high quality work under tight deadlines.
- Collaborative and proactive approach a must.
- Self-starter and able to work in a fast-paced environment within a matrix organization.
- A desire to get a product to market.
Required Experience
- Bachelor's of Science degree in the Life Sciences.
- 1-2 years of industry experience/internship within a manufacturing/production environment preferred, preferably in a small company/start-up setting.
- 1-2 years of microbiology experience preferred but not required.