Director - Vaccine Testing Labs
Thermo Fisher Scientific
Summary
The Director, Vaccine Science oversees a dedicated team of scientists and technicians. The Dir serves as the primary contact for a large pharmaceutical customer to ensure successful implementation and execution of program objectives. The Dir supervises and assists group leaders, scientists, and laboratory technologists in complex operations. The Dir 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 Dir assists the Business Unit Leadership Team in strategic planning, business development and expansion initiatives.
Job description
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. 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 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.
Requirements
- Ph.D. in Biological Science required.
- Proven experience and track record in Vaccine clinical research and/or Bioanalytical Labs
- Previous experience comparable to 10+ years or equivalent combination of education, training, & experience
- 5+ years of management responsibility
- Proven leadership skills
- 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
Benefits
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Health Incentive Programs
- Employee Assistance Programs
- Family Support Programs
- Commuter Benefits
- Tuition Reimbursement
- Paid Time Off
- Paid Holidays
- Paid Parental Leave
- Accident Insurance
- Life Insurance
- Short-Term Disability Insurance
- Long-Term Disability Insurance
- 401(k) Retirement Savings Plan
- Employee Stock Purchase Plan
- Annual Performance Bonus
Company overview
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. The company's mission is to enable customers to make the world healthier, cleaner, and safer. With over 100,000 employees globally, Thermo Fisher provides an unrivaled combination of innovative technologies, purchasing convenience, and pharmaceutical services through its industry-leading brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. The company serves customers across healthcare, life sciences, applied markets, and pharmaceutical sectors, offering solutions that accelerate research, solve complex analytical challenges, improve patient diagnostics, and increase laboratory productivity. Headquartered in Waltham, Massachusetts, Thermo Fisher operates globally, delivering critical scientific products, services, and workflow solutions that support researchers, organizations, and companies in addressing some of the world's most pressing issues.