Senior Microbiologist: GMP Lab Leader & Growth

Actalent; Town of Florida (NY); Híbrido; USD 7 285 000 - 7 947 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Disability coverage

HSA option

PTO / Vacation or Sick Leave

Resumo da oferta

Actalent is seeking a Sr QC Microbiologist to provide technical leadership for a growing analytical microbiology laboratory. This role supports GMP-compliant operations for product release, API batch release, and stability studies, and is based in Jupiter, FL with a hybrid work arrangement.

The ideal candidate brings 7+ years of GMP pharmaceutical microbiology experience, strong technical writing, and expertise in IQ/OQ/PQ, environmental monitoring, and regulatory inspections.

Qualificações

• Bachelor's degree in Microbiology or a related scientific discipline.
• At least seven years of GMP pharmaceutical microbiology experience.
• Strong experience with technical writing, equipment qualification, and laboratory validation.
• Previous experience supporting regulatory inspections and client audits.
• Demonstrated knowledge of pharmaceutical microbiology and cGMP laboratory operations.
• Excellent communication, organization, leadership, and project-management skills.
• Ability to manage multiple laboratory priorities in a growing operational environment.

Responsabilidades

• Provide technical leadership for the analytical microbiology laboratory.
• Support the design, startup, and expansion of GMP-compliant laboratory operations.
• Lead the selection, qualification, and implementation of analytical instrumentation, including IQ, OQ, and PQ activities.
• Develop and maintain standard operating procedures, laboratory protocols, technical reports, and training programs.
• Perform and oversee method suitability, process verification, and microbiological testing activities.
• Establish and maintain environmental monitoring programs for cleanrooms and separative devices.
• Partner with Quality Assurance to support investigations, corrective and preventive actions, and overall cGMP compliance.
• Serve as the microbiology subject-matter expert during client interactions, regulatory inspections, and audits.
• Support laboratory accreditation activities, including alignment with ISO/IEC requirements.
• Establish programs for procurement, qualification, handling, storage, inventory control, traceability, and routine use of reference standard and challenge organisms.
• Ensure microbiological reference materials and laboratory practices comply with applicable USP requirements and recognized industry standards.
• Supervise, train, and professionally develop QC laboratory analysts as laboratory operations expand.
• Manage sample schedules, testing priorities, and laboratory workflow.
• Improve laboratory efficiency, throughput, and testing capacity.
• Oversee microbiological media, reference organisms, and related inventory.
• Coordinate activities with QC Chemistry and Quality Assurance.
• Support laboratory investigations and stability studies.
• Expand the laboratorys testing capabilities to meet operational and client needs.

Conhecimentos

Microbiology

Environmental monitoring

Aseptic technique

Bioburden testing

Quality control

Plating

Microbial testing

Laboratory leadership

Formação académica

Bachelor's degree in Microbiology or related discipline

Master's degree preferred

Descrição da oferta de emprego

Actalent is seeking a Sr QC Microbiologist to provide technical leadership for a growing analytical microbiology laboratory. This role supports GMP-compliant operations for product release, API batch release, and stability studies, and is based in Jupiter, FL with a hybrid work arrangement.

The ideal candidate brings 7+ years of GMP pharmaceutical microbiology experience, strong technical writing, and expertise in IQ/OQ/PQ, environmental monitoring, and regulatory inspections.