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We are seeking a highly motivated individual who will be responsible for manufacturing and testing of monoclonal antibodies through various stages of production. This position is accountable for performing a wide variety of laboratory tasks within a team environment. Specifically, performing monoclonal antibody conjugation, purification, and fragmentation protocols, as well as running Flow Cytometry, ELISA, Bioassay, and western Blot assays. The qualified candidate is expected to apply hand-on training to troubleshoot technical challenges in both production and testing of innovative antibody-based assays. Additional responsibilities include preparing protocols for experiments of simple to moderate complexity under minimal supervision, preparing technical reports, and summaries of assigned projects. Must be comfortable performing bench science, and in self-direction of work plans and experimental procedures.
- The ideal candidate will have a minimum of 3 years’ experience in production and testing of monoclonal antibodies and possess in-depth knowledge on the theory and application of various protein characterization techniques and the accompanying instrumentation.
- Perform Purification, conjugation and fragmentation protocols.
- Conduct in-process and final product testing and generate testing results reports.
- Responsible for assuring that products are manufactured and tested to meet the highest quality standards.
- Complete all batch records and manufacturing documents according to quality systems standards.
- Complete production schedule to plan maintaining sufficient output levels.
- Cross train with upstream group and other groups as necessary.
- Works cross-functionally to efficiently release product, resolve problems and provide support to other departments across the organization (e.g., Quality Assurance, Planning, Quality Control, etc.)
- Manage several projects concurrently to meet aggressive deadlines.
- Use root cause analysis tools to complete Non-Conforming Material Reports (NCMRs)
- Participate in corrective and preventive actions (CAPA) related activities, including CAPA ownership if appropriate.
- Ability to function, with minimal guidance, in a rapidly changing environment while balancing multiple priorities simultaneously.
- The candidate will be expected to effectively interact with members of numerous project teams and present experimental results at team meetings and seminars.
- Must be able to work well independently and as part of a group.
- May perform other related duties that requires effective multitasking.