Vice President, Biologics

About the role

The Vice President, Biologics Development role is a dual-mandate position aimed at establishing Syner-G's presence in the West Coast biologics market, particularly in the Bay Area, San Diego, and Seattle biotech corridors. This role will 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. The candidate will also represent Syner-G at industry events, client meetings, and professional forums in the biologics space.

Responsibilities

• Establish and grow Syner-G's presence in the West Coast biologics market, focusing 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.
• Lead and personally execute biologics CMC consulting engagements, serving as the primary technical point of contact across the 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.
• Partner with Syner-G's broader Pharm Dev and Quality organizations to deliver integrated solutions that draw on the full firm capability.
• Maintain delivery accountability on engagements personally owned, holding the standard for quality and client satisfaction that defines the Syner-G reputation.
• Contribute to the build-out of Syner-G's West Coast team over time, including input on talent strategy and hiring for the region.
• Provide leadership-level perspective on biologics market trends, client segment dynamics, and capability gaps that should inform Syner-G's service evolution.

Qualifications and Requirements

• Advanced degree (Ph.D., M.S., or equivalent) in biochemistry, chemical engineering, pharmaceutical sciences, or a related field.
• 20+ 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.
• Strong understanding of lyophilization process engineering, freeze-drying technologies, equipment performance, cycle development support, and sterile manufacturing operations.
• Expertise in commissioning, qualification, startup, performance verification, and operational readiness methodologies.
• Advanced understanding of automation platforms, SCADA systems, PLCs, control philosophies, alarms, permissives, interlocks, and system integration strategies.
• Strong technical troubleshooting, risk assessment, and problem-solving capabilities.
• Exceptional leadership, communication, client relationship management, and business development skills.
• Ability to establish credibility with executive leadership, technical stakeholders, equipment vendors, and regulatory-facing organizations.
• 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.
• Demonstrated ability to build lasting client relationships and convert technical expertise into long-term business partnerships.