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Summary
We are looking for an experienced and motivated candidate to join our Process Development team. The successful candidate will work to develop test methods or processes in a high-volume manufacturing environment.
Client Details
Our client is a leading provider of biomarker analysis whose cutting edge technology is currently being used to detect oncology, neurology, cardiology, inflammation and infectious disease.Description
- Plan and execute analytical studies while applying current Good Laboratory and Documentation Practices, to help optimize and characterize the performance of raw material, intermediates, or finish good immunoassay reagents
- Regularly present data and findings to technical teams for discussion
- Author test methods, study protocols and technical reports
- Identify and implement process improvements by thinking critically about the execution of all experiments.
- Collaborate with R&D and Assay Development members to transition development protocols into production, including validation experiments, automation, and SOP development.
- Execute IQ/OQ/PQ of new analytical equipment as needed
- May participate in design and process risk evaluation, mitigation and management
Profile
- BS / BA in molecular biology, (bio)chemistry, genetics, or a related field with 5+ years in the life sciences preferably assay development or manufacturing in clinical diagnostics industry and/or start-up environment.
- MS in biology/chemistry/genetics disciplines as above, with 3+ years experience
- Hands-on experience with molecular biology or microbiology techniques
- Excellent interpersonal skills and ability to function in a team environment are essential
- Experience with apply statistical tools including DOE, Gage R&R, process capability, and Statistical Process Control a plus
- Knowledgeable of ISO 13485, ISO 14971, 21 CFR 820 is a plus
Job Offer
- Competitive base salary and benefit package
- Opportunity to join brand new process development team and build from the ground up
- Join quickly growing biotech organization with massive growth opportunity
Company:Michael PageLocation:Billerica - Massachusetts - United StatesJob Types:Full TimePost Date:October 25, 2021Valid Through:November 24, 2021