Associate Director - Vaccine Testing Labs

What You'll Do:

• Interact with clients and business development on requests for proposals and project definition.
• Prepare, review and approve bids and proposals, scope of work and pricing.
• Manage/direct work responsibilities of group leaders as well as prioritize tasks and resources.
• Review data for technical quality and compliance to protocols, methods and SOPs.
• Review and approves laboratory investigation, deviations, and QA facility and data audits.
• Lead client and regulatory audits.
• Prepare and update revenue projection reports, review Partner and timesheet reports for revenue recognition and billing, evaluate resource utilization reports and project profitability.
• Review and approve study protocols, project status reports, final study reports and other project related technical documentation.
• Assist in technical sales and marketing, prepare technical marketing materials, and participate in poster and podium presentations in technical conferences.
• Assist upper management in strategic planning, budgeting, new capabilities development and other responsibilities.
• Prepare and implement SOPs and company operational policies.
• Ensure adherence and makes recommendations to quality system improvements.

Requirements:

• Ph.D. in Biological Science preferred but not required.
• Proven experience and track record in Vaccine clinical research and/or Bioanalytical Labs.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years) or equivalent and relevant combination of education, training, & experience.
• 5+ years of management responsibility.
• Proven leadership skills.

Knowledge, Skills, Abilities:

• Full understanding of laboratory requirements, PPD and client SOPs, ICH guidelines, USP requirements and FDA guidance.
• Proven technical troubleshooting analytical instrumentation and problem solving abilities.
• Excellent written and oral communication skills.
• Project and time management skills.
• Ability to implement quality systems and process improvements.
• Ability to provide guidance to clients on analytical issues and regulatory requirements.
• Knowledge of budgeting, forecasting and fiscal management.
• Demonstrated coaching and mentoring skills.
• Demonstrated strategic planning skills.
• Strong organizational agility and demonstrated drive for results.