Jobs at Syner-G

Leads CMC drug substance and drug product development programs across client engagements. Manages integrated project plans, clinical supplies forecasting and distribution, packaging and labeling, budgets, risks, vendors, timelines, and cross-functional stakeholders. Facilitates governance and client meetings, prepares status reporting, supports regulatory activities, maintains client relationships, and contributes to business development. The role may require travel to client sites up to 100% based on project needs.

Support reliability, maintenance, and asset management for GMP pharmaceutical/biotech facilities. Improve PM programs, perform criticality assessments and RCAs, analyze failure data, use CMMS, recommend life-extension and spare-parts strategies, and collaborate cross-functionally to reduce downtime and improve asset availability.

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.

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.

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 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 regulatory review and risk assessment of US and Canadian promotional materials across channels to ensure compliance with FDA/OPDP, Health Canada, and PAAB. Advise cross-functional teams on claim substantiation, evidence use, launch and lifecycle promotional strategy, support submissions/preclearance, deliver training, and monitor regulatory developments. Role involves stakeholder collaboration and may require extensive client travel.