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Astrazeneca5 days ago

Microbiology Laboratory Supervisor — Radio Conjugate Laboratory

$86,266–$113,225 year

On-site · Hamilton, Ontario, Canada

Type
Full Time
Level
Mid Level
Education
Bachelors Degree
Company size
Enterprise

Job Summary

Lead and mentor the microbiology team to supervise all microbiological control activities in a regulated aseptic radiopharmaceutical manufacturing environment, including environmental monitoring, contamination control, and sterilization practices. Oversee risk assessments, CAPA implementation, data integrity, method validations, and cross-functional collaboration with Quality, Engineering, Production, and Validation to ensure GMP compliance across EU, FDA, PIC/S, ICH, ISO, USP/Ph. Eur./JP standards for radioconjugate products. Ensure adherence to regulatory requirements, maintain cleanroom controls and gowning, and support rapid-release manufacturing in a Hamilton, Ontario facility. The role requires expertise in environmental monitoring programs (EMPQ), contamination control strategies (CCS), and radiopharmaceutical-specific oversight, with willingness to work extended shifts and travel as needed.

Required Qualifications

  • Bachelor’s degree in Microbiology, Biological Sciences, or related discipline
  • 5–8 years of experience supervising or leading teams in a laboratory or sterile/aseptic manufacturing environment
  • Experience with environmental monitoring, contamination control, cleanroom operations, and regulatory compliance (EU Annex 1, cGMP, etc.)
  • Willingness for extended shifts, weekends, or holidays; occasional after-hours support
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$86k – $113k / yr

Microbiology Laboratory Supervisor — Radio Conjugate Laboratory · Astrazeneca

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