Oligonucleotide Chemistry Expert

3 days ago

Framingham, Massachusetts, United States Lifelancer Full time
About the Role:
We are seeking an exceptional Pharmaceutical Development Specialist to join our team. The ideal candidate will have extensive experience in developing and optimizing synthetic processes to support drug development programs, with a proven track record of delivering results in a fast-paced environment. In this role, you will be responsible for supporting our Biotechnology/Pharmaceutical clients across all stages of development, including serving as client lead/project-lead to support the successful development of small molecule active pharmaceutical ingredients (APIs).

Responsibilities:
  • Plan and execute activities collaboratively with the client related to the development and manufacturing of small molecules and active pharmaceutical ingredients (APIs).
  • Draft RFPs, identify potential CROs/CMOs, review proposals, and independently manage multiple drug substance CROs and CMOs during various phases of pharmaceutical development.
  • Oversee and manage technical drug substance route scoping, manufacturing, starting materials, risk-assessments, process transfer activities, manufacturing process scale-up and CTM manufacturing campaigns.
  • Review and approve master and executed batch records.
  • Author and review DS-related CMC sections for IND/CTA/IMPD/NDA regulatory filings.
  • Provide CMC technical due diligence to support business development/in-licensing efforts for clients.

Requirements:
  • A bachelor's or advanced degree in chemistry, biochemistry, chemical engineering, or relevant discipline is required.
  • Extensive experience (>8 years) as a team member in developing/optimizing synthetic processes to support drug development programs.
  • Experience with mRNA/oligonucleotides.
  • Proven track record demonstrating productive and collaborative interactions within a multi-disciplinary team driven towards pharmaceutical development.
  • Excellent written and verbal communication skills.
What We Offer:
  • A market competitive base salary: $120,000 - $180,000 per year.
  • A comprehensive benefits package, including health insurance, retirement plan, and paid time off.
  • The opportunity to work on high-profile projects with a team of experts in the life sciences industry.
  • Ongoing recognition and career development opportunities.
  • The ability to work remotely full-time with flexible working hours.

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