Head of Oligonucleotide Process Chemistry
Job Description
About This Role
The Head of Oligonucleotide Process Chemistry leads the Oligonucleotide Process Chemistry department which provides support to all pre-clinical and clinical oligonucleotide programs. The main roles of the department are selection and optimization of the chemical routes to manufacture oligonucleotides; identification and selection of suppliers for production of starting materials and/or clinical active ingredient; close collaboration with and transfer of manufacturing processes to our internal oligonucleotide manufacturing facility or to selected external suppliers; oversight over production of toxicology supplies and clinical material; development of innovative manufacturing technologies. In this role you will hire, retain, and develop scientists. You work with our oligonucleotide purification, drug product and analytical development teams, and across disciplines to influence and implement CMC development strategies for oligonucleotide drug candidates. This includes authoring scientific publications to promote innovation and influence regulations, ensuring timely delivery of clinical and launch supplies, and expanding industry leading knowledge in relevant scientific areas.
What You’ll Do
  • Provide leadership and develop strategic direction for the department to ensure business objectives are met. Influence and approve CMC strategies for oligonucleotide clinical assets.
  • Prioritize resources and budget allocation and liaise with stakeholder functions (Research & Development, Asset Development Portfolio Management, Quality, Regulatory, Procurement, etc.) to ensure on time delivery of pre-clinical and clinical material
  • Lead or participate in cross-functional teams to develop roadmaps for continuous improvement initiatives
  • Lead or participate in cross-industry collaborations to advance innovation and influence regulations
  • Identify and engage with external partners to develop and sustain important business relationships
Who You Are
You exhibit scientific leadership, business acumen, and strategic agility. You have a demonstrated ability to drive novel results, and lead innovation and change.
  • PhD in Chemistry or relevant discipline
Required Skills
  • 10+ years of relevant experience with a preference of 12+ years, preferably in a biopharma / biotech environment
  • Successful track record in process chemistry managing teams of people and chemical innovation
  • Strong people leadership skills and an interest in developing talent
  • Experience with clinical and commercial regulatory filings, and responding to agency queries
  • Experience in cross-functional projects and working with external manufacturing partners
  • Proven track record of publications
Preferred Skills
  • Experience with nucleoside, nucleotide, or oligonucleotide synthesis

To apply for this job please visit orbiterrecruiting.com.