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 oligonucleotide 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 GMP production for clinical evaluation (Phase 1-3). This includes active oversight of process establishment, process development, scale-down model verification, and process characterization. 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, Regulatory Affairs, and Project Management to meet the needs of Dyne’s complex clinical supply chain, supporting our preclinical and clinical programs.

This role is based in Waltham, MA without the possibility of being a remote role. Physical presence onsite is expected on 4-5 days/week.

Primary Responsibilities Include:

• Responsible for drug substance bioconjugation including process development, tech transfer, scale-up, and process characterization of oligonucleotide conjugates.
• Lead internal CMC Process Development activities via hands-on contribution in the laboratory.
• 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 bioconjugation Drug Substance process as a technical leader in internal cross-functional CMC teams.
• Establish clear expectations and priorities, set objectives, and effectively apply resources to deliver on program goals.
• Select, qualify and manage external contract development and manufacturing organizations.
• Drive continuous improvement opportunities, adapt to and solve challenges and lead the timely resolution of issues.
• Evaluate and implement emerging technologies/applications to improve conjugation processes and optimize purification methods.
• Partner with internal cross functional teams and serve as the liaison to define suitable, compliant, and defendable CMC strategies.
• Prepare technical source documents, publications, and oral presentations.
• Prepare and review relevant CMC and product related sections and documentation for global regulatory submission.
• Review and approve documents related to development and cGMP operations, including Tech Transfer, Process Characterization, Master Batch Records (MBRs) and Campaign Summary Reports.

Education and Skills Requirements:

• PhD or equivalent experience in a scientific discipline and a minimum of 5+ years related experience working with bioconjugates including a deep understanding of conjugation chemistries, preparative chromatography, and TFF. 
• Experience in biopharmaceutical CMC management and/or Research & Development preferably in a clinical-stage biotechnology company.
• Familiarity working with oligonucleotides including but not limited to morpholino oligonucleotides, antisense 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)
• Ability to problem solve emerging issues related to drug substance development.
• 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 that can work collaboratively with colleagues across functions.

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