Associate Director - Vaccine Testing Labs [Remote]

JOB DESCRIPTION

Work Schedule

Environmental Conditions

Job Description

The Associate Director, Vaccine Science oversees a dedicated team of scientists and technicians. The AD serves as the primary contact for a large pharmaceutical customer to ensure successful implementation and execution of program objectives. The AD supervises and assists group leaders, scientists, and laboratory technologists in complex operations. The AD ensures scheduling, resource management, technical and compliance related issues are managed appropriately. This role plans, directs and implements improvements in systems, processes and procedures to increase efficiency, productivity and quality in the laboratory. Additionally, the AD assists the Business Unit Leadership Team in strategic planning, business development and expansion initiatives.

• 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. Negotiate with clients on timelines 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.

Education & Experience 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

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

• 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.