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Global drug and device development services

Senior Manager - Laboratory Operations

Diagnostics & Laboratory ProfessionalsConfirmed live in the last 24 hours
Full-timeFarmingdale, NY, USA

About the Job

Requirements

  • An advanced degree (PhD, MD, DO, MSc, or BSc) in a clinical, biological, chemical, or laboratory science is required.
  • At least 10 years of progressive leadership experience in clinical or specialty laboratory operations is required.
  • Demonstrated experience leading CAP/CLIA-accredited specialty laboratories and managing regulatory inspections is required.
  • A proven track record of scaling laboratory operations and delivering financial performance is required.
  • ASCP certification and a New York State license are required.
  • Laboratory leadership experience in a clinical testing laboratory is required.
  • Regulatory experience with CAP, CLIA, or global equivalents is required.
  • P&L management and investment governance experience is required.
  • Change leadership, automation, and digital transformation experience are required.
  • Stakeholder engagement with Medical, Quality, Commercial, and Clients is required.
  • Talent development and succession planning experience is required.

Responsibilities

  • Develop, implement, and manage staff performance standards related to quality, efficiency, and productivity.
  • Manage adherence to written internal and external quality-control procedures and evaluate means and standard deviations for quality-control materials; maintain corrective-action logs as appropriate.
  • Assist management with recruiting and selecting staff.
  • Liaise with clients, vendors, and staff on department issues.
  • Participate in root-cause analysis investigations and process-improvement initiatives; respond accurately and on time to assigned quality issues.
  • Assess work performance and conduct employee performance evaluations.
  • Review daily, weekly, and monthly department metrics and reallocate staffing as needed to ensure efficiency and quality.
  • Oversee staff work, set team priorities, coordinate work activities and schedules, and arrange work outside normal hours when required.
  • Develop staff skills, encourage growth, provide regular performance feedback, and mentor and coach staff.
  • Manage staff recruitment, training, and development across laboratory sections; provide continuing education for laboratory staff in laboratory sections and sample management.
  • Ensure the quality and timeliness of technical procedures and compliance with CAP, relevant government regulations, GDP, and other applicable standards.
  • Monitor reagents and supplies and assist with inventory management.
  • Oversee reagent and supply orders, approve inventory purchases, code invoices, and work with Corporate Procurement to negotiate vendor pricing and service requirements.
  • Monitor laboratory operations and guide staff in addressing instrument failures, reagent or quality-control issues, sample integrity issues, testing delays, and abnormal-result communication.
  • Manage evaluation and validation of new methodologies and instrumentation in collaboration with the Global Validations Department.
  • Manage compliance with applicable employee health and safety regulations and requirements.
  • Approve purchase orders and other appropriate departmental purchases.

About the Company

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Global drug and device development services

This company provides consulting, development, and commercialization support for drugs and medical devices through a global network of offices. Its team across 53 countries offers end-to-end services, from strategy and regulatory work to manufacturing and market access, helping clients shorten development time, lower costs, and raise quality. It differentiates itself with wide geographic reach and a clear focus on reducing time to market and cost while leveraging deep experience across many therapeutic areas. Its goal is to help clients accelerate the development of life-saving products and improve quality of life by delivering reliable information, practical solutions, and solid performance.

Company size
10,001+
Company stage
IPO
Headquarters
Ireland
Founded
1990

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