Senior Consultant

Emploi pas sur LinkedIn

🕒 il y a 17 jours

🇺🇸 États-Unis – Télétravail

⏰ Temps Plein

🟠 Senior

💼 Consultant

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

Postuler Maintenant

Trouver des Emplois à Distance Similaires

Configurer une alerte email pour les nouveaux emplois

📊 Vérifiez votre score de CV pour ce poste

Améliorez vos chances d'obtenir un entretien en vérifiant votre score de CV avant de postuler.

Télécharger le CV

Syner-G BioPharma Group

Site WebLinkedInTous les Emplois

201 - 500 employés

🏥 Santé

💼 Conseil

🏭 Fabrication

Healthcare • Consulting • Manufacturing

Syner-G BioPharma Group est le leader mondial dans la fourniture de solutions en chimie, fabrication et contrôles (CMC), affaires réglementaires, et rédaction médicale pour le secteur biopharmaceutique. Ils offrent des services complets qui guident les clients à travers les complexités du développement pharmaceutique, des soumissions réglementaires, et de la conformité qualité, assurant des résultats de haute qualité. Avec une équipe multidisciplinaire, Syner-G intègre la science, l'ingénierie et l'expertise réglementaire pour soutenir le développement de médicaments depuis les phases pré-IND jusqu'à la post-approbation, permettant des soumissions en temps opportun et une adhésion à la sécurité des patients.

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.

🎯 Exigences

• 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.

🏖️ Avantages

• Health insurance • Flexible working hours • Professional development opportunities