As a Scientist in the Specialty Production group, you will use your molecular biology expertise to determine the most efficient way to fulfill customer specialty product requests. You will work with Product Management to assess specialty product requests and coordinate delivery timelines. The job will include recovering genes that fail pipeline processing and using your troubleshooting skills to complete difficult orders, working with Production to produce specialty products, working with Automation Engineers to specify new methods required to make custom products, and tracking specialty samples across multiple projects simultaneously. You will report to the Production Development Senior Scientist. The ideal candidate will be driven and will do what takes to keep manufacturing on track in a fast paced environment, be very organized, have excellent molecular biology knowledge and DNA cloning skills. You will work independently, contribute to process improvement and documentation, and communicate effectively with peers and management. This is a production role that relies heavily on development skills. You must be comfortable working in a LEAN manufacturing/ controlled laboratory environment.
- Work closely with Development Scientists and Product Management to gain thorough understanding of new custom projects.
- Collaborate with Development Scientists to transform process knowledge into robotic methods for specialty product production.
- Develop and maintain project timelines and provide updates and feedback to project leadership.
- Independently design experimental plans, perform studies, analyze large data sets, and report study results and recommendations both verbally and in written formats.
- Define product specifications, processing parameters and operational boundaries.
- Work with software engineers to develop LIMS features and support the specialty process.
- Collaborate with Automation team to develop and optimize high throughput methods.
- Collaborate with QC team to evaluate and monitor new processes.
- Become fluent with end-to-end product workflows.
- Write technical documents including work instructions, batch records, SOP’s and training documents for manufacturing operators.
- Develop test plans, protocols and reports to ensure designs and processes meet product specifications, regulatory requirements and industry standards.
- Train manufacturing operators when necessary.
- Own all aspects of tech transfer for new products including post-release QA
- Ph.D. in Biochemistry, Molecular Biology, Microbiology, Bioengineering, Genetics or related field
- 2+ years industrial experience in biotechnology product development and/or technical transfer
- Background in molecular biology techniques including PCR, DNA purification (column and bead based), DNA quantification (absorbance and fluorescence), DNA assembly (Gibson, Golden Gate, Restriction Enzyme), and molecular cloning.
- Excellent troubleshooting skills
- Highly organized and detailed oriented
- Highly motivated and strong work ethic
- Experience with Tableau, Spotfire, or JMP
- Familiar with SQL
- Proven ability to launch products in a biotechnology or life sciences company
- Ability to work in a fast paced, team environment
- Experience with automation platforms such as Hamilton/Biomek/Tecan or Echo is a plus