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Syner-G

Sr. Consultant

RemoteUnited States onlyArchived
Published
Experience
Lead
Salary not disclosed
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Open to US only. Set where you work from to check your eligibility.

No BS summary

Senior CMC consultant with 15+ years in pharmaceutical, biopharmaceutical, biotech, or cell and gene therapy. Must lead CMC strategy, technical operations, regulatory support, CDMO/CMO relationships, and drug substance/drug product development.

What you'll do

  • Serve as a trusted CMC advisor to clients, providing strategic guidance across all phases of product development.
  • Lead and manage CMC development activities for drug substances and drug products, ensuring alignment with program objectives and regulatory requirements.
  • Oversee CDMO/CMO selection, qualification, contracting, and ongoing management to support development and manufacturing activities.
  • Develop and maintain strong client relationships while serving as the primary technical point of contact for assigned programs.
  • Provide technical leadership and strategic oversight for analytical development, process development, technology transfer, manufacturing, and product characterization activities.
  • Review, author, and provide final approval of CMC-related regulatory documents and submissions supporting clinical trials and commercial programs globally.
  • Collaborate with cross-functional teams, including Regulatory Affairs, Quality, Nonclinical, Clinical, Manufacturing, and Supply Chain stakeholders.
  • Identify program risks, develop mitigation strategies, and proactively resolve technical and operational challenges.
  • Facilitate decision-making processes and provide recommendations based on scientific, technical, regulatory, and business considerations.
  • Support project planning, execution, timeline management, and milestone tracking to ensure successful program delivery.
  • Participate in business development activities, proposal development, client presentations, and marketing initiatives.
  • Mentor junior consultants and contribute to the continued growth of Syner-G's technical capabilities and consulting excellence.

What they require

  • Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biology, Chemical Engineering, Life Sciences, or a related scientific discipline required.
  • Preferred: Advanced degree (M.S., Ph.D., Pharm.D., or equivalent) preferred.
  • 15+ years of experience within the Pharmaceutical, Biopharmaceutical, Biotechnology, Cell and Gene Therapy industries.
  • Extensive expertise across the full CMC lifecycle, including development of drug substances and drug products.
  • Demonstrated experience leading CMC strategy, technical operations, and regulatory support activities.
  • Experience managing CDMO/CMO relationships and external development and manufacturing partners.
  • Exceptional communication skills.
  • Ability to influence cross-functional teams and external partners.
  • Proven track record of successfully advancing development programs from early-stage development through commercialization.
  • Ability to operate independently while partnering closely with clients, Contract Development and Manufacturing Organizations (CDMOs/CMOs), regulatory agencies, and internal teams.

Benefits

  • Culture with emphasis on career growth and development opportunities, financial rewards, leadership and innovation.
  • Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year.
  • Learning support.
  • Rewards in many different ways.

Syner-G

Syner-G is a strategic biopharma product development and delivery partner supporting clients from drug discovery and approval through commercialization.

Biopharma

Details

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Salary not disclosed