Scientist, Process Development
We are seeking a talented and highly motivated individual to join our multi-disciplinary team as a Scientist - Process Development.
This individual will be a key contributor to executing reagent formulation activities including technology transfer, process development, analytical method development, verification and validation. The position
will be located in Lexington, MA. Responsibilities: Development, optimization, scale up, and validation of reagent processes and measurement systems; including DOE and capability analysis. Experimental planning, execution, and data analysis. Ownership of authoring and managing technology transfer plans for new products transitioning from Product Development to Manufacturing.
Author and perform protocols for verification and validation of manufacturing processes and equipment. Identification, development, and implementation of new manufacturing equipment and processes including execution of process capability studies. Identification of potential process improvements for reagent manufacturing processes. Ownership of troubleshooting technical issues through root cause analysis and subsequent preventive or corrective actions (CAPA). Maintain detailed documentation records and author reports, SOPs, batch records and other materials to facilitate tech transfer, manufacturing and regulatory submissions.
Skills and Background: 8+/6+ years of background in the in vitro diagnostics industry. B. S. /M. S. in Biology, Biochemistry, Biotechnology or related fields. Background with molecular biology techniques (DNA purification, PCR, q PCR, etc). Background with process and equipment validation (reagent formulation, mixing, and filling) preferred. Background with process scale up (500 m L to ten L) involving magnetic beads, biological material, and/or oligonucleotides a plus.
Background transferring processes from R&D to Manufacturing (GLP to GMP environments) a plus. Demonstrated excellence in planning, executing, troubleshooting and analyzing experiments. Excellent organizational, record keeping and communication (verbal and written) skills. Strong work ethic to generate high-quality work under aggressive deadlines. Collaborative and proactive approach. Self-starter and able to work in a fast-paced environment within a matrix organization. recblid tqnmcgq9dbx0wacwbfqsdk3ukkyamb BA/BS/Undergraduate
Location: Lexington, MA
Company: T2 Biosystems