Position Summary:We are looking for driven, talented Process Engineers to join the Manufacturing Technology & Transfer team within Global Operations. This position is an integral part of our Reagent Development team and is tasked with developing and deploying oligonucleotide manufacturing processes. The individual will partner closely with development teams, Quality, Production, Supply Chain, and other engineering groups to develop and transfer sustainable manufacturing processes.
Responsibilities:- Execute feasibility and development oligonucleotide builds as necessary to support various projects timelines
- Ideate and create manufacturing processes and define technical requirements for new production equipment
- Author procedures and instructions for new manufacturing processes and train production operators to manufacture product in a GMP environment
- Troubleshoot new product and manufacturing process issues related to yield, quality and throughput
- Construct and execute controlled experiments including DOE's to optimize processes and scale; address yield/quality issues and drive implementation of solutions into a production environment to meet project goals
- Analyze process test results, author reports and inform technical recommendations to improve product and process quality
- Work cross functionally with Product Development, Supply Chain, Manufacturing, Quality, EHS and Facilities teams by representing Oligo MTT on NPI core teams
- Ensure successful transfer of knowledge into manufacturing and the sustaining support teams
Requirements:- Expertise with all oligonucleotide processes (synthesis, cleavage/deprotection, purification, desalting, and in-process and final QC) and equipment (synthesizers, preparative HPLCs, analytical HPLCs, MSs, UV Specs, etc)
- Experience with liquid handlers and ERP systems is a plus
- Demonstrated ability to accomplish goals while working across departments
- Effective communication (both verbal and written) and organizational skills to manage competing project priorities
- Expertise with Statistics, Statistical Process Control and DOE techniques
- Experience with cGMP and 21 CFR part 11 and supporting manufacturing in an FDA regulated environment is preferred
- Experience with high volume production in a high tech consumables industry is a plus
- Experience with product development processes and project management is a plus
Education / Experience:- Typically requires a minimum of 5 years of related oligonucleotide experience with a Bachelor's degree; or 3+ years and a Master's degree; or a PhD without experience in Chemistry, Biochemistry, Chemical Engineering or equivalent
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
The estimated base salary range for the Sr Engineer - Process Development role based in the United States of America is: $98,400 - $147,600. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. The range reflects long-term growth in the role; therefore, most candidates are hired between the minimum and middle of the range. Placement depends on experience, skills, location, and internal equity. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.
