Senior Consultant

Job not on LinkedIn

🕒 5 days ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

💼 Consultant

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Syner-G BioPharma Group

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Syner-G BioPharma Group is the world's leading provider of chemistry, manufacturing and controls (CMC), regulatory affairs, and medical writing solutions for the biopharma sector. They offer comprehensive services that navigate clients through the complexities of pharmaceutical development, regulatory submissions, and quality compliance, ensuring high-quality outcomes. With a multidisciplinary team, Syner-G integrates science, engineering, and regulatory expertise to support drug development from pre-IND to post-approval phases, enabling timely submissions and patient safety adherence.

📋 Description

• 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.

🎯 Requirements

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biology, Chemical Engineering, Life Sciences, or a related scientific discipline required. • 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.

🏖️ Benefits

• Health insurance • Flexible working hours • Professional development opportunities