Vice President, Biologics

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🕒 il y a 26 jours

🇺🇸 États-Unis – Télétravail

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👔 Vice-président

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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

• Lead and personally execute biologics CMC consulting engagements, serving as the primary technical point of contact across program lifecycle • Provide expert guidance across biologics development including upstream and downstream process development, analytical characterization, drug substance and drug product manufacturing, and CMC regulatory strategy • Author and provide strategic input on CMC regulatory submissions including INDs, BLAs, and agency meeting packages • Maintain delivery accountability on engagements personally owned, holding the standard for quality and client satisfaction that defines the Syner-G reputation • Establish and grow Syner-G's presence in the West Coast biologics market, with particular focus on the Bay Area, San Diego, and Seattle biotech corridors • Leverage an existing network of biologics sponsor and CRO relationships to open doors, build pipeline, and position Syner-G as a credible biologics CMC partner • Collaborate with senior leadership on proposal development, pricing strategy, and scope definition for West Coast opportunities • Represent Syner-G at industry events, client meetings, and professional forums in the biologics space • Serve as a named resource in client proposals and scope-of-work documents, lending personal credibility to Syner-G's biologics capability narrative • Contribute to the build-out of Syner-G's West Coast team over time, including input on talent strategy and hiring for the region • Serve as a senior biologics resource across the national delivery organization, sharing expertise and supporting other consultants on complex programs • Provide leadership-level perspective on biologics market trends, client segment dynamics, and capability gaps that should inform Syner-G's service evolution

🎯 Exigences

• Advanced degree (Ph.D., M.S., or equivalent) in biochemistry, chemical engineering, pharmaceutical sciences, or a related field. • 20 plus years of biologics CMC experience with substantive time at a major biologics sponsor (Gilead, Amgen, Genzyme, BioMarin, or equivalent large-molecule organization) • Deep technical expertise in at least two of the following: upstream process development, downstream purification, analytical development and characterization, drug product formulation, or CMC regulatory affairs for biologics • Demonstrated track record of independent technical ownership on IND-enabling through late-stage or commercial biologics programs • Prior experience in business development, client relationship ownership, or commercial engagement at a CRO, CDMO, or consulting firm • Prior consulting or advisory firm experience with demonstrated ability to manage client relationships in a fee-for-service environment (preferred) • Experience managing or mentoring junior technical staff on client engagements (preferred) • Strong knowledge of aseptic processing requirements, contamination control strategies, Annex 1 guidance, GMP regulations, and pharmaceutical manufacturing best practices. • Strong project management and organizational skills with the ability to manage multiple high-profile initiatives simultaneously. • Ability to mentor teams, drive technical excellence, and support organizational growth.

🏖️ Avantages

• market competitive base salary and annual incentive plan • robust benefit offerings • ongoing recognition and career development opportunities • generous flexible paid time off program • company-paid holidays • flexible working hours • fully remote work options for most positions • ability to work “almost anywhere”