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:
- 6-8+ years of experience in the in vitro diagnostics industry
- BS/MS in Biology, Biochemistry, Biotechnology or related fields
- Experience with molecular biology techniques (DNA purification, PCR, qPCR, etc)
- Experience with process and equipment validation
- 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 a must.
- Self-starter and able to work in a fast-paced environment within a matrix organization.
Required Skills
Required Experience