Senior Director, Process Engineering

Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington’s disease, as well as a preclinical program in obesity. Driven by the calling to “Reimagine Possible”, we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.

Description:  

• Wave Life Sciences USA, Inc. seeks a Senior Director, Process Engineering for Lexington, MA

Experience:

• Master’s degree, or foreign equivalent, in chemical engineering/related field and 6 years’ experience in process engineering with a focus on oligonucleotide manufacturing technology. 
• Experience must include 2 years exp. in each of the following, which may be gained concurrently:
  • Design of process and equipment for the following process technologies - Multicolumn solvent gradient purification (MCSGP), spiral membrane filtration and single pass TFF.
  • Development and implementation of PAT technologies such as Inline RAMAN, IR and Mass Spec and process control for monitoring and control of GMP oligonucleotide processing. 
  • Design and development of oligonucleotide synthesizer and cleavage & deprotection reactor for batch and continuous process
  • Utilizing modelling tools such as Super pro, schedule pro, Dynochem etc specific to oligonucleotide applications. 
  • Conceptual process and plant design for a multi-modal (RNA editing, Anti-sense oligonucleotide, siRNA) clinical stage stereopure Oligonucleotide manufacturing plant employing process engineering equipment and facility 
  • Process safety evaluation of equipment and utilities handling novel chemistries such as PN-modified stereopure oligonucleotides and sodium azide
  • API experience in the design and development of flow reaction equipment for liquid phase reactions such as cleavage and deprotection, and Phosphoramidite synthesis.
  • Employing Quality based design (QbD) approaches to process and facility design for Nucleic acid therapeutics.
  • Developing lyophilization process, equipment design and process optimization of siRNA molecules.

Responsibilities:     

• Deliver leadership in chemical manufacturing processes and facility equipment to enable the transfer of new drug products into Wave’s multi-modal (RNA editing, Anti-sense oligonucleotide, siRNA) clinical stage stereo pure Oligonucleotide manufacturing plant. 
• Lead teams responsible for design, implementation, and qualification of cGMP oligonucleotide manufacturing process, plant equipment, and control systems, including solid phase synthesis, Multicolumn solvent gradient purification (MCSGP), spiral membrane filtration and single pass TFF for manufacturing chemicals and products such as Active Pharmaceutical Ingredients (API) and drug product formulations. 
• Maintain primary responsibility for monitoring and analyzing data from manufacturing scale processes and lab or pilot scale experiments involving reactions and separations in support of oligonucleotide process transfer, and clinical manufacturing. 
• Lead development of safety procedures and implementation of appropriate engineering controls to maximize safety for employees working on chemical reactions that include PN-modified stereopure oligonucleotides and sodium azide. 
• Lead teams responsible for troubleshooting problems (e.g equipment function, yield, purity) with cGMP API organic synthesis and separation processes in electrically hazardous (class 1 Div 2.), ISO classified locations (Full job description available upon request).