Vice President, Biologics

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee and actively lead biologics CMC consulting projects, serving as the main technical liaison throughout the program lifecycle.

• Deliver expert insights across biologics development, including upstream and downstream process development, analytical characterization, manufacturing of drug substances and products, and CMC regulatory strategies.

• Write and provide strategic direction on CMC regulatory submissions, including INDs, BLAs, and meeting packages for regulatory agencies.

• Ensure accountability for the delivery of engagements that you personally manage, upholding the quality and client satisfaction standards that characterize Syner-G's reputation.

• Establish and enhance Syner-G's visibility in the West Coast biologics market, focusing specifically on the biotech corridors of the Bay Area, San Diego, and Seattle.

• Utilize an established network of relationships with biologics sponsors and CROs to create opportunities, develop a pipeline, and position Syner-G as a trusted partner in biologics CMC.

• Collaborate with senior management on the development of proposals, pricing strategies, and defining scopes for opportunities on the West Coast.

• Represent Syner-G at industry events, client meetings, and professional gatherings within the biologics domain.

• Act as a named resource in client proposals and scope-of-work documents, enhancing Syner-G's narrative of biologics capabilities through personal credibility.

• Contribute to the growth of Syner-G's West Coast team over time, including providing input on talent strategy and regional hiring.

• Serve as a senior biologics resource across the national delivery organization, sharing expertise and aiding other consultants with complex programs.

• Provide leadership-level insights on trends in the biologics market, dynamics within client segments, and capability gaps that should guide Syner-G's service development.

⛳️ Requirements

• An advanced degree (Ph.D., M.S., or equivalent) in biochemistry, chemical engineering, pharmaceutical sciences, or a related discipline.

• Over 20 years of experience in biologics CMC, with significant tenure at a major biologics sponsor such as Gilead, Amgen, Genzyme, BioMarin, or another large-molecule organization.

• Extensive technical expertise in at least two of the following areas: upstream process development, downstream purification, analytical development and characterization, drug product formulation, or CMC regulatory affairs for biologics.

• A proven track record of independent technical leadership on IND-enabling through late-stage or commercial biologics projects.

• Previous experience in business development, client relationship management, or commercial engagement at a CRO, CDMO, or consulting agency.

• Experience working at a consulting or advisory firm with a proven ability to manage client relationships in a fee-for-service context (preferred).

• Experience in mentoring or managing junior technical staff on client projects (preferred).

• In-depth knowledge of aseptic processing requirements, contamination control strategies, Annex 1 guidelines, GMP regulations, and best practices in pharmaceutical manufacturing.

• Strong project management and organizational capabilities with the ability to oversee multiple high-profile initiatives concurrently.

• Capacity to mentor teams, promote technical excellence, and support organizational growth.

🏝️ Benefits

• Competitive base salary and annual incentive plan.

• Comprehensive benefits packages.

• Continuous recognition and opportunities for career development.

• Generous flexible paid time off program.

• Company-paid holidays.

• Flexible working hours.

• Fully remote work options available for most positions.

• Ability to work “almost anywhere.”