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Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Director – Vaccine Testing Labs

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeRichmond, VA, USA

About the Job

Requirements

  • A Ph.D. in Biological Science is required.
  • Proven experience and a track record in vaccine clinical research and/or bioanalytical laboratories.
  • Comparable to 10 or more years of relevant experience, or an equivalent relevant combination of education, training, and experience.
  • At least 5 years of management responsibility.
  • Full understanding of laboratory requirements, PPD and client standard operating procedures, ICH guidelines, USP requirements, and FDA guidance.
  • Technical troubleshooting of analytical instrumentation and problem-solving abilities.
  • Project and time management skills.
  • Ability to implement quality systems and process improvements.
  • Ability to provide clients with guidance 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 drive for results.

Responsibilities

  • Serve as the primary contact for a large pharmaceutical customer to ensure successful implementation and execution of program objectives.
  • Supervise and assist group leaders, scientists, and laboratory technologists in complex operations.
  • Manage scheduling, resource management, and technical and compliance-related issues.
  • Plan, direct, and implement improvements in laboratory systems, processes, and procedures to increase efficiency, productivity, and quality.
  • Assist the Business Unit Leadership Team with 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, scopes of work, and pricing; 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 standard operating procedures.
  • Review and approve laboratory investigations, deviations, and quality assurance 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 at technical conferences.
  • Assist upper management with strategic planning, budgeting, new capabilities development, and other responsibilities.
  • Prepare and implement standard operating procedures and company operational policies; ensure adherence and recommend quality system improvements.

About the Company

Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Thermo Fisher Scientific makes and sells the instruments, chemicals, consumables and lab services that drug companies, hospitals, universities and industrial labs use for research, testing and production. Its products cover work from gene sequencing and protein analysis to diagnostic tests and lab freezers, and its distribution arm ships supplies to labs worldwide. Drug developers also hire it to run clinical trials and to manufacture medicines under contract. It earns money from consumables that labs buy again and again, along with instrument sales, service contracts and outsourcing fees. The company traces its roots to Thermo Electron, founded in 1956, which merged with Fisher Scientific in 2006, and it is based in Waltham, Massachusetts.

Company size
10,001+
Company stage
IPO
Headquarters
Waltham, MA
Founded
1956

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