Scientist, Process Development
T2 Biosystems, Inc.
Lexington, MA
Full-time
Science
Posted on July 31, 2020
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 Experience:
- 8+/6+ years of experience in the in vitro diagnostics industry.
- B.S./M.S. in Biology, Biochemistry, Biotechnology or related fields.
- Experience with molecular biology techniques (DNA purification, PCR, qPCR, etc).
- Experience with process and equipment validation (reagent formulation, mixing, and filling) preferred.
- Experience with process scale up (500 mL to 10 L) involving magnetic beads, biological material, and/or oligonucleotides a plus.
- Experience 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 tight deadlines.
- Collaborative and proactive approach.
- Self-starter and able to work in a fast-paced environment within a matrix organization.