Vice President, Biologics

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🕒 vor 24 Tagen

🇺🇸 Vereinigte Staaten – Remote

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Syner-G BioPharma Group

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201 - 500 Mitarbeiter

🏥 Gesundheitswesen

💼 Beratung

🏭 Fertigung

Healthcare • Consulting • Manufacturing

Die Syner-G BioPharma Group ist der weltweit führende Anbieter von Lösungen in den Bereichen Chemie, Herstellung und Kontrolle (CMC), regulatorische Angelegenheiten und medizinisches Schreiben für den Biopharma-Sektor. Sie bieten umfassende Dienstleistungen, die Kunden durch die Komplexitäten der pharmazeutischen Entwicklung, regulatorische Einreichungen und Qualitätssicherung navigieren, um qualitativ hochwertige Ergebnisse sicherzustellen. Mit einem interdisziplinären Team integriert Syner-G wissenschaftliche, ingenieurtechnische und regulatorische Expertise, um die Arzneimittelentwicklung von der Vor-IND-Phase bis zur Phase nach der Zulassung zu unterstützen, was zeitgerechte Einreichungen und die Einhaltung der Patientensicherheit ermöglicht.

Beschreibung

• 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

🎯 Anforderungen

• 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.

🏖️ Vorteile

• 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”