Consultant for Drug Substance Development

4 days ago


Framingham, Massachusetts, United States Lifelancer Full time
Job Overview:
Syner-G BioPharma Group and Sequoia Biotech Consulting are seeking a highly experienced Pharmaceutical Development Specialist to join our team. As a key member of our team, you will support 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:
  • Develop and execute strategies for the development and manufacturing of small molecules and active pharmaceutical ingredients (APIs).
  • Manage relationships with CROs, CMOs, and testing labs to support pharmaceutical drug substance 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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