Director - Vaccine Testing Labs
About The Position
The Director, Vaccine Science oversees a dedicated team of scientists and technicians and serves as the primary contact for a large pharmaceutical customer, ensuring successful implementation and execution of program objectives. The Director supervises and assists group leaders, scientists, and laboratory technologists in complex operations, and ensures that scheduling, resource management, technical matters, and compliance issues are handled appropriately. The role plans, directs, and implements improvements to laboratory systems, processes, and procedures to increase efficiency, productivity, and quality. It also supports the Business Unit Leadership Team with strategic planning, business development, and expansion initiatives.
Requirements
- Ph.D. in Biological Science.
- Proven experience and track record in vaccine clinical research and/or bioanalytical laboratories.
- Comparable to 10+ years of relevant experience, or an equivalent and relevant combination of education, training, and experience.
- At least 5 years of management responsibility.
- Proven leadership skills.
- Full understanding of laboratory requirements, PPD and client SOPs, ICH guidelines, USP requirements, and FDA guidance.
- Technical troubleshooting abilities with 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 advise clients on analytical issues and regulatory requirements.
- Knowledge of budgeting, forecasting, and fiscal management.
- Coaching and mentoring skills.
- Strategic planning skills.
- Strong organizational agility and demonstrated drive for results.
Responsibilities
- Interact with clients and business development on requests for proposals and project definition; prepare, review, and approve bids, proposals, scopes of work, and pricing; and negotiate timelines and pricing with clients.
- Manage and direct group leaders’ work responsibilities and prioritize tasks and resources.
- Review data for technical quality and compliance with protocols, methods, and SOPs; review and approve laboratory investigations, deviations, and QA facility and data audits; and lead client and regulatory audits.
- Prepare and update revenue projection reports; review partner and timesheet reports for revenue recognition and billing; and evaluate resource utilization and project profitability.
- Review and approve study protocols, project status reports, final study reports, and other project-related technical documentation.
- Assist with technical sales and marketing, prepare technical marketing materials, and participate in poster and podium presentations at technical conferences.
- Assist upper management with strategic planning, budgeting, new capabilities development, and other responsibilities.
- Prepare and implement SOPs and company operational policies, ensure adherence, and recommend quality-system improvements.
Benefits
- National medical and dental plan options and a national vision plan, including health incentive programs.
- Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
- At least 120 hours of paid time off and 10 paid holidays annually.
- Paid parental leave: 3 weeks for bonding and 8 weeks for caregiver leave.
- Accident and life insurance, and short- and long-term disability in accordance with company policy.
- Competitive 401(k) U.S. retirement savings plan.
- Employees’ Stock Purchase Plan, offering eligible colleagues the opportunity to purchase company stock at a discount.
- Potential eligibility for a variable annual bonus based on company, team, and/or individual performance results, in accordance with company policy.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
