The Sr. Oligonucleotide Chemist-Design Transfer is the process technical expert in all elements of manufacturing Oligonucleotides. This position is responsible for establishing method validation protocols and executing validation studies for oligonucleotide synthesis, purification and purity analysis. It is expected that the person in this position will work closely with the Chemistry research and development group to facilitate the transfer of test methods and processes developed in research to the Manufacturing operation. Responsibilities include drafting and execution of validation protocols, evaluate and improve processes, and management of timelines
Key Responsibilities of the Job:
- Review nucleotide product manufacturing documents to ensure quality procedures are met and plan/prioritize to address potential production issues.
- Work with Chemistry research and development group to lead/participate in troubleshooting activities related to oligonucleotide, phosphoramidite and triphosphate synthesis (CAPA and otherwise) and lead documentation changes and procedures.
- Lead continuous improvement activities for:
- -- oligo synthesis - adjust process to meet production capacity needs and ensure any appropriate documentation changes are established through the change control process.
- -- oligo analysis – In conjunction with Chemistry research and development, regularly evaluate and advise on the process to ensure effectiveness according to industry standard practice and confirm performance (chemically reasonable impurities)
- -- triphosphate synthesis - In conjunction with Chemistry research and development incorporate synthetic method improvements into the manufacturing processes and be responsible for ensuring that appropriate documentation changes are established through the change control process.
- Performs change control as required to support change requirements including engineering change orders, document change orders and deviations.
- Participates in the evaluation and approval of manufacturing processes and resources to successfully introduce new products and/or apply major changes to existing products. Provides input to new product and project schedules for new process and/or test method deliverables.
- Facilitates/participates in cross functional teams to establish new outsource providers as necessary. Coordinate outsource testing and interface with outsource providers as the technical representative as needed.
- Guide and advise on the proper purchase, installation, use, and maintenance of laboratory equipment for manufacturing use. Work in collaboration with Chemistry research and development to define any new product/process requirements and propose for capitol budgets.
- Work with Chemistry research and development group on new product development to ensure knowledge transfer into manufacturing.
- Participate on manufacturing and project teams as required.
- Ensures that nucleotide synthesis team is properly trained on systems, processes & equipment.
- Assure that quality procedures and instructions are being followed and results are meeting objectives.
- Participate in meeting site safety and chemical hygiene requirements; may provide leadership as Chemical Hygiene Officer as required and if appropriate.
- Investigate complaints and non-conformances. Develop and implement corrective and preventive actions.
- Perform additional tasks as assigned.