Manufacturing Process Development and Transfer Scientist

POSITION: Manufacturing Process Development and Transfer ScientistREPORTS TO: Head of Global Supply Chain and ManufacturingDEPARTMENT: OperationsSTATUS: ExemptPOSITION OVERVIEWWe are seeking an experienced process-oriented scientist to join us as a Manufacturing Process Development and Transfer Scientist. Your role will be to optimize manufacturing processes associated with TwinStrands Duplex Sequencing (DS) library preparation kits, validate reagents, and act as a liaison between the R&D and manufacturing departments for the transfer of DS products in a scalable fashion.As a member of the Manufacturing and Supply Chain team you will have responsibility for planning, executing, optimizing, troubleshooting and documenting of experimental processes as they move from R&D into production at scale. In this role, you will utilize and leverage your experience with molecular biology techniques and laboratory automation to identify, mitigate, and correct assay issues that will potentially cause problems after transfer to the production environment.This role acts as a key bridge between R&D and manufacturing operations, providing directional and hands-on support to both. You will work closely with members of the R&D, QA and manufacturing teams in support of troubleshooting experimentation to enable efficient and scalable lab operations. Additionally, you will be responsible for working with the R&D and QA on defining and implementing final and in-process QC protocols for qualifying incoming materials and final products of our manufacturing operations, including performing QC testing and NGS library prep.Success in this role will require familiarity with ISO 9001/ ISO13485 and GMP compliance requirements, hands on experience in tech transfer from R&D to manufacturing, scaling up of biochemical processes, and ability to effectively communicate, listen and deliver knowledge in a collaborative manner.RESPONSIBILITIES* Prepare, aliquot, document, and validate reagents for TwinStrands DS kits.* Plan and execute validation and verification experiments, including DS library preparation and sequencing.* Collaborate cross-functionally with Quality, R&D, and Custom Applications to establish and maintain a successful tech transfer process for new and updated products.* Prepare protocols, reports, and test methods; author & revise controlled documents, including product/component manufacturing Standard Operating Procedures, Work Instructions and Policies.* Work closely with QA to document the SOPs in line with ISO and GMP requirements.* Understand the R&D lab workflow and work with the manufacturing team to identify and implement process optimizations that increase manufacturing efficiency and finished product stability.* In collaboration with QA and R&D, define QC parameters and protocols and perform QC testing on incoming manufacturing materials as well as final products. Support manufacturing and QA in defining and documenting in-process QC protocols to assure quality of intermediate and final materials and products.* Support training and technical support for manufacturing staff on new protocols; provide troubleshooting and guidance to manufacturing staff.* Maintain and ensure safe manufacturing/laboratory environment and work practices.* Execute, appropriately record and evaluate experimental data, including the writing and revising of process development reports and technology transfer protocols as needed.* Maintain rigorous electronic records within the LIMS, detailing all work and ensure all data and records are appropriately documented.* Perform function checks, routine QC, preventative maintenance and calibrations on manufacturing and QC instrumentation.* Participate in the deviation and corrective and preventative action (CAPA) program, including conducting root cause analysis, trending, monitoring and coordination of interdepartmental corrective action and preventative activities.* Ensure timely completion of deliverables and provide documentation and reports, where applicable.* Maintain consistently high-performance standards and quality of work.* Maintain rigorous laboratory practice to prevent DNA amplicon contamination.* Active preparation and participation in regulatory inspections, internal gap analysis, and third-party client audits.* Follow all safety and company policies and procedures.* Present data, issues, findings and proposed solutions to the involved internal stakeholders.* This role is expected to spend at least 50% of time on bench work.* Additional responsibilities might be added as the manufacturing team is growing and evolving.EXPERIENCE AND CAPABILITIES* PhD in a related scientific field or MS/bachelors degree with about 5 years work experience in a laboratory setting.* Proven track record of developing or transferring molecular biology applications.* Industrial experience optimizing lab workflows and procedures.* Hands-on experience with NGS is preferred.* Close familiarity with ISO 9001/ ISO13485 and GMP compliance requirements is required.* Proven ability to acquire and transfer knowledge, skills and techniques to team members at all levels in the organization.* Track record of successful cross-functional teamwork, troubleshooting and curiosity.* Excellent written and verbal communication skills.* Attention to details and thoroughness, with the ability to work independently.* Strong multi-tasking and time management skills.PHYSICAL AND TRAVEL REQUIREMENTS* Prolonged periods sitting at a desk/lab bench and working on a computer.* Must be able to lift up to 15 pounds at times.* Ability to travel up to 5% of time.OUTSTANDING CANDIDATES WILL* Have prior experience with error-corrected NGS library prep or data analysis and knowledge on DNA modifying enzymes and oligos used in NGS assay.* Have strong data analysis skills, including using command line to process NGS data.* Have prior experience with QC practices in cGMP environments.* Have recent experience in creating new processes and leading initiatives.WHAT WE OFFER* A mission to be proud of. You will help to provide access to a technology with unprecedented sensitivity that makes it possible to solve previously unsolvable scientific problems in basic research and translational medicine, with direct and immediate benefits to human health.* Beautiful new waterfront facility overlooking Puget Sound, centrally located in downtown Seattle.* Competitive compensation plan.* Comprehensive benefits: medical, dental and vision benefits for employees and dependents, sponsored life, short and long-term disability insurance, and 401(k) retirement savings plan.* Subsidized transportation program: parking, bus, ferry, rideshare and more.* Onsite gym, showers, bike storage.* Social events, weekly happy hours, well-stocked kitchen.* Recognition that outside life exists and is important, that flexibility is needed for family and that work can sometimes be effectively carried out remotely.* Casual, but high-performing work environment.