About the role:

We are seeking a Senior Scientist to join the Process Development team to lead the development of oligonucleotide synthesis, purification, characterization and QC strategies, methods, and processes for transfer to manufacturing. This is a unique cross-disciplinary position that will work closely with a variety of groups including Chemistry, Molecular Biology, Manufacturing Systems Engineering, Manufacturing, and QC.

Candidates must have extensive experience in both process development and oligonucleotide manufacturing with a deep understanding of the underlying chemistry involved. The candidate will utilize proven design of experiment (DOE) principals to optimize all physical, chemical, and environmental aspects of the synthesis and purification methods to ensure the processes developed are efficient, high-yielding, reliable, and robust prior to documenting them and transferring to manufacturing. It is critical that appropriate in-line controls, monitoring, and QC methods are established, validated, and implemented to guarantee processes remain in control and any excursions from nominal values are identified early in the production cycle.    

Individuals applying for this position must be creative, passionate, detail-oriented self-starters who thrive in a fast-paced environment through actions driven by strategic thinking. In addition, successful candidates will be flexible in changing direction and approaches, excel at managing multiple priorities, succeed in communicating with all levels within the organization, and provide immediate contribution.

What you will be doing:

• Leading the conception, development, and optimization of robust, high-throughput, plate-based oligonucleotide manufacturing methods and processes in preparation for transfer to production
• Establishing suitable purification processes for diverse classes of oligonucleotides with varying physical properties at different scales
• Planning and performing systematic workflow and reagent optimization by modeling, guard band studies, identification of critical factors, and use of formal design of experiment (DOE) approaches. This includes in-depth analysis and reporting of your data through documentation and presentations to internal groups.
• Identifying and optimizing any compounding factors, such as temperature, environment, workflow, pressures, reagent concentrations, etc. that could impact the resulting product
• Developing and validating new QC methods to assess the suitability, stability, and functionality of a range of oligonucleotides through a variety of analytical and functional tests
• Implementing routine process QC methods to ensure processes are in control
• Identification and implementation of statistical process control tools
• Verifying that the manufactured products output meets all predetermined requirements
• Driving the technology transfer phase as new products move from process development into manufacturing in preparation for commercial launch
• Installation and verification of equipment, documenting processes, and training operators
• Independently troubleshooting and resolving reagent formulation, process, QC, and incoming material issues
• Providing technical leadership in the production and analysis of oligonucleotides to identify continuous improvement opportunities
• Guiding infrastructure requirements to build out internal oligonucleotide manufacturing capabilities
• Working closely with computational and molecular biologists to interpret data generated by novel assays

Minimum Requirements:

• PhD. in Chemistry, Biochemistry, Chemical Engineering, or related field
• 3+ years industry experience in oligonucleotide manufacturing process development and/or manufacturing
• Extensive experience with plate-based oligonucleotide synthesis instrumentation (e.g. Dr Oligo, Mermade) and subsequent plate-based downstream processing
• Proven hands-on experience in the synthesis, purification, and QC of oligonucleotides as evidenced by peer-reviewed publications, published patents, or commercialized products
• Expert technical knowledge of nucleotide modifications and oligonucleotide synthesis, purification, and QC methods, techniques, strategies, and equipment
• Ability to meticulously design and execute on meaningful experiments and perform in-depth analyses of the resultant data. Experience using statistical tools, such as JMP, is beneficial.
• Exceptionally strong troubleshooting and problem-solving skills
• Ability to integrate a broad range of scientific and engineering disciplines
• Experience developing and implementing novel QC methods to assess reagent performance in both functional and orthogonal assays
• Proven track record of ability to develop, validate, and transfer processes to manufacturing or OEM vendors
• Strong process transfer experience, demonstrating control of manufacturing processes through appropriate Process Design and QC methods
• Proven ability to write SOPs and train others to successfully perform the work.
• Strong organizational, collaboration, and written and oral communication skills
• Desire to be part of a rapidly evolving organization with the ability to work in a fast-paced and quickly changing environment

Preferred Skills/Experience:

• Experience in GMP, GLP setting and good documentation practices preferred
• Experience using statistical tools, such as JMP to analyze complex data sets, create DOE experiments, and data trending
• Previous work guiding the development of new manufacturing and production infrastructure
• Experience operating liquid handling robots and other common laboratory automation tools, ability to program these instruments would be very beneficial

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