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Syner-G

Vice President, Biologics

УдалённоUnited States только
Опубликовано
Роль
Развитие бизнеса
Опыт
Лид
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Коротко по делу

VP-level biologics CMC leader with 20+ years in large-molecule development, including major sponsor experience. Must bring West Coast biologics network, business development/client ownership, and ability to lead hands-on CMC consulting engagements. Remote role with up to 75–100% travel.

Ключевые навыки

Biologics CMCLyophilizationBusiness Development

Обязательные навыки

SCADAPLCGMPAnnex 1

Чем предстоит заниматься

  • 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
  • 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
  • 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
  • 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

Что требуется

  • 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
  • Preferred: 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
  • Deep understanding of lyophilization process engineering, freeze-drying technologies, equipment performance, cycle development support, and sterile manufacturing operations.
  • Strong knowledge of aseptic processing requirements, contamination control strategies, Annex 1 guidance, GMP regulations, and pharmaceutical manufacturing best practices.
  • 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.
  • Travel may be required up to 75–100%, depending on client and project needs.
  • While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen.
  • The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds.
  • The employee is occasionally required to stand, stoop, or kneel.
  • Specific vision abilities required by this position include close vision and the ability to adjust focus.

Преимущества

  • Market competitive base salary
  • 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”
  • Office locations in Greater Boston; San Diego, CA; Boulder, CO; and India

Syner-G

Syner-G is a strategic biopharma product development and delivery partner supporting clients from drug discovery and approval through commercialization.

Biopharma

Что говорят о компании

4.6/ 5

  • Employees appreciate the supportive work culture.
  • There are opportunities for professional development.
  • Many reviews highlight a positive team dynamic.

Детали

Способ откликаGreenhouse
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