Consultant for Drug Substance Development
4 days ago
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.
- 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.
- 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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