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Vice President, Biologics

1 month ago
Anywhere
Full-time
Executive
Business Development
Sales and Business Development
Apply Now
Syner-G BioPharma

Syner-G BioPharma

Syner G BioPharma Group offers leading CMC & Regulatory Affairs solutions for biopharma, specializing in strategic CMC 360 services, global regulatory affairs, and quality compliance to support successful drug development.

Professional Services
51-250
Founded 2007
View All Jobs 7

Description

  • Establish and grow Syner-G's presence in the West Coast biologics market, especially in the Bay Area, San Diego, and Seattle.
  • Leverage existing sponsor and CRO relationships to 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 new opportunities.
  • Represent Syner-G at industry events, client meetings, and professional forums.
  • Serve as a named resource in client proposals and scope-of-work documents.
  • Lead and personally execute biologics CMC consulting engagements as the primary technical point of contact.
  • Provide expert guidance across upstream and downstream process development, analytical characterization, manufacturing, and CMC regulatory strategy.
  • Author and provide strategic input on CMC regulatory submissions, including INDs, BLAs, and agency meeting packages.
  • Partner with Pharm Dev and Quality teams to deliver integrated solutions.
  • Contribute to West Coast team build-out, including input on talent strategy and hiring.

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 substantial time at a major biologics sponsor such as Gilead, Amgen, Genzyme, BioMarin, or equivalent.
  • Deep technical expertise in at least two areas: upstream process development, downstream purification, analytical development and characterization, drug product formulation, or CMC regulatory affairs for biologics.
  • Demonstrated 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.
  • Preferred: prior consulting or advisory firm experience with client management in a fee-for-service environment.
  • Preferred: experience managing or mentoring junior technical staff on client engagements.
  • Strong knowledge of lyophilization process engineering, freeze-drying technologies, sterile manufacturing operations, aseptic processing, contamination control, Annex 1 guidance, and GMP regulations.
  • 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, problem-solving, leadership, communication, project management, and organizational skills.
  • Ability to travel up to 75–100% depending on client and project needs.

Benefits

  • Market-competitive base salary with annual incentive plan.
  • Robust benefits package.
  • Generous flexible paid time off program.
  • Company-paid holidays.
  • Flexible working hours.
  • Fully remote work options for most positions.
  • Ability to work from almost anywhere.
  • Office locations available in Greater Boston, San Diego, Boulder, and India for those who prefer a physical location.

Interested in this position?

Apply directly on the company website

Apply Now

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