CMC Regulatory Affairs Consultant, Peptides and Oligonucleotides
Location
New York
Posted
44 days ago
Salary
Not specified
Seniority
Senior
Bachelor Degree5 yrs expEnglish
Job Description
• Partner with a large global biopharmaceutical client and lead regulatory CMC strategy for peptide and oligonucleotide therapeutics
• Drive global regulatory strategy and submission activities for complex synthetic and nucleic acid–based products
• Collaborate closely with R&D, CMC, clinical, and quality teams to ensure compliance with international standards and accelerate successful product approvals
Job Requirements
- Bachelor’s or Master’s degree in chemistry, biochemistry, pharmaceutical sciences, or related discipline
- Ph.D. in organic chemistry is preferred if possible
- 4-7 years in peptide or oligonucleotide synthesis, purification, and analytical testing (HPLC, LC-MS, NMR)
- Hands-on experience with solid-phase synthesis or phosphoramidite-based workflows
- Familiarity with purity, identity, sequence confirmation, and impurity profiling requirements per FDA/ICH/USP standards
- Strong understanding of regulatory requirements for synthetic peptides and oligonucleotides
- Proven track record preparing CMC documents and regulatory submissions
- Proficiency in chromatography (HPLC/UPLC), LC-MS, UV‑Vis, NMR, and sequence confirmation tools
- Experience with automated or scale‑up synthesis platforms, lab instruments, and LIMS/electronic lab notebooks
- Experience with conjugation strategies (e.g., peptide-oligo, ligand-oligo constructs)
- Knowledge of global regulations (FDA, EMA, ICH) for biologics and oligo therapeutics
- Process development or GMP exposure in peptide/oligo manufacturing settings
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
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