Syner-G
Sr. Consultant
УдалённоUnited States толькоВ архиве
- Опыт
- Лид
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Коротко по делу
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.
Чем предстоит заниматься
- 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.
Что требуется
- 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.
Преимущества
- 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 is a strategic biopharma product development and delivery partner supporting clients from drug discovery and approval through commercialization.
Biopharma
Что говорят о компании
4.6/ 5
- Employees appreciate the supportive work culture.
- There are opportunities for professional development.
- Many reviews highlight a positive team dynamic.
Детали
Способ откликаGreenhouse
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