Senior Scientist, Process Development Bioconjugation

Role Summary:

The position is responsible for process development, technology transfer, and management of external CDMO activities to ensure development of robust and reliable GMP manufacturing processes for antibody drug conjugates and intermediates. The Senior Scientist will represent CMC Process Sciences as a technical leader and provide guidance to internal process development staff and external vendors on oligonucleotide conjugate development and manufacturing activities from pre-clinical to BLA and commercial production. This includes active oversight and hands on contributions to process establishment, process development, process characterization, and validation.  This person will also have direct oversight of CDMO technology transfer and process development operations. 

This position works closely with key stakeholders including Platform Research, External Manufacturing, Clinical Operations, Regulatory Affairs, and Project Management to define and build the capabilities required to effectively manage Dyne’s complex clinical supply chain supporting launch and commercialization efforts.

This role is based in Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate to the area.

Primary Responsibilities Include:

• Responsible for drug substance bioconjugation including process development, tech transfer, scale-up, characterization, and validation of oligonucleotide conjugates
• Lead internal CMC Process Development activities via hands-on contribution and management of laboratory staff
• Work with CDMOs to manage external process development, optimization, and tech transfer of new programs in a stage appropriate manner to ensure key milestones and products are delivered on schedule
• Partner with Research to support bioconjugation development activities and enhance the tech transfer process to external manufacturing partners
• Represent CMC and Process Sciences as a technical leader in internal cross-functional teams
• Prepare and review CMC regulatory documentation for biologic INDs and BLAs in support of relevant interactions with health authorities
• Establish clear expectations and priorities, set objectives, and effectively apply resources to deliver on program goals
• Serve as a scientific leader within CMC by contributing creative ideas and new innovations that enable better products and processes.

 Education and Skills Requirements:

• Degree in biology, biochemistry, chemistry, or similar related life science or engineering field is required
• A minimum of 5 years in biopharmaceutical CMC management and/or Research & Development preferably in a clinical-stage biotechnology company
• Experience working with bioconjugates including a deep understanding of conjugation chemistries, preparative chromatography, and TFF is required
• Familiarity working with oligonucleotides including but not limited to antisense oligonucleotides, morpholino oligonucleotides, and siRNA is desired
• Hands on experience with analytical techniques for characterization of conjugates including HPLC/UPLC, SEC, SDS-PAGE, ion exchange chromatography, and UV/vis.
• Experience with oversight of external contract development and manufacturing (CDMO) partners
• Ability to challenge current processes, practices, and strategy to uncover alternative approaches, solutions, or methods
• A strong understanding of biologics and small molecule manufacturing, analytical development, quality control, quality assurance, and regulatory functions
• Self-directed individual who is able to work effectively with limited direction in a complex, fast-paced environment
• Excellent interpersonal, organizational, negotiation, and communication skills; a team member than can work collaboratively with colleagues across functions

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