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Principal Scientist, Process Development (Nucleic Acid and Oligonucleotide Chemistry)

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We look for a highly energetic individual who has deep technical knowledge in nucleic acid and oligonucleotide chemistry (e.g. mRNA, gRNA, pDNA), production, characterization and scale up. He/She will be a strategic leader responsible for technical development and CMC activities that enable lab scale production process to be transferred to a CRO. In addition to technical expertise, the ideal candidate should also possess the ability to successfully interface with multidisciplinary teams, engage and collaborate with external partners in process development and manufacturing. This position will play an important role in developing the manufacturing process and analytical methods for mRNA, gRNA and pDNA molecules.

 

Primary Responsibilities:

  • Builds and leads a group of scientists in overseeing clinical preparedness
  • Independently plans and executes process development, assay development, characterization and qualification studies
  • Prepares study protocols, reports, tech transfer documentation, and regulatory documents for clinical trials
  • Provides technical leadership to project teams within area of expertise and commits resources to execute specific project tasks
  • Good understanding of cGMP environment, DOEs, QbD principles, risk management
  • Reviews, interprets and communicates data cross-functionally within CMC and/or project teams
  • Serves as a technical resource for junior staff
  • Understands project timelines and deliverables and plans/coordinates project work accordingly with departmental, functional and external stakeholders
  • Builds and maintains relationships with key vendors and assists with technical aspects of vendor negotiations
  • Proactively analyses mRNA manufacturing issues and coordinates potential resolution with the team

 

Qualifications:

  • PhD or MS in Pharmaceutical Sciences, Chemistry, Biotechnology, Chemical Engineering
  • 8-10 years of experience in a Pharmaceutical or a CRO/CMO organization around Nucleic acid chemistry
  • Prior success engaging with cross functional teams internally
  • Experience working with external CRO/CMO’s
  • cGMP experience a plus
  • Independent thinker and team player