Jobs at Syner-G

Lead regulatory strategy for clients across drug development stages, author and submit NDA/BLA/IND materials, manage FDA interactions (Type A/B/C), coordinate global submissions, evaluate manufacturing/quality impacts, mentor staff, and provide regulatory advice and industry thought leadership.

Lead Syner-G's West Coast biologics practice, drive business development, and personally deliver biologics CMC consulting across upstream/downstream/analytical/formulation. Author CMC regulatory submissions (INDs, BLAs), mentor staff, build regional team, and represent the firm at industry events. Role requires deep technical ownership and frequent client travel.

Lead cross-functional project teams to define scope, manage budgets and resources, mitigate risks, ensure regulatory compliance, maintain client/vendor relationships, drive process improvements, and deliver project documentation and reports for biopharma programs.

Lead analytical development for oligonucleotide and peptide products across clinical phases: design, validate, and execute methods; perform characterization and stability testing; manage CDMO method transfers and comparability protocols; prepare regulatory submissions (IND/CTA); collaborate with CMC teams; mentor junior staff; and support project timelines and stakeholder communications.

Serve as CMC leader for biologics and cell/gene therapy programs: provide strategic guidance, manage CDMO/CMO relationships, oversee analytical/process development, technology transfer, manufacturing and regulatory CMC submissions, mitigate program risks, lead cross-functional teams, mentor junior consultants, and support business development to advance programs to commercialization.

Lead enterprise AI strategy, prioritize high-value use cases, and oversee end-to-end model development, MLOps, governance, deployment, and adoption. Build and mentor AI teams, partner with technology and business units, manage vendors and budgets, and measure business impact while ensuring responsible AI practices and stakeholder alignment.

Lead sponsor-side GCP quality and compliance for biotech clients: design sponsor oversight, conduct GCP/vendor/site audits, prepare for inspections, author audit/CAPA reports, advise on regulatory submissions, and manage multiple client engagements to ensure inspection-readiness and RBQM alignment.

General company overview and invitation to submit a general application for future roles across Syner-G. Applicants are encouraged to apply for consideration; the recruiting team will contact candidates when a suitable position opens.