Teams 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.