Senior Scientist, Process Development - Bioconjugation

Primary Responsibilities

• 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.
• 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.
• Prioritize and set objectives for internal and external teams, and effectively apply resources to deliver on program goals.
• Prepare technical source documents, publications, and oral presentations.
• 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.
• 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).
• Problem solving ability related to 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.