Aseptic Microbiology Specialist

We are seeking a skilled Aseptic Microbiology Specialist to join our team at Perspective Therapeutics. This role is responsible for ensuring the microbiological quality of our products and processes, adhering to all applicable regulations and standards.

Main Responsibilities:

• Develop and implement contamination control strategies for aseptic manufacture and supply of clinical trial radiopharmaceutical drug products.
• Oversee aseptic and microbiological training of site staff, ensuring they meet industry standards.
• Conduct microbiological testing of raw materials, in-process samples, finished products, and environmental monitoring samples, verifying data accuracy.
• Perform sterility testing, endotoxin testing, microbial limits testing, and other relevant assays according to SOPs and cGMP guidelines.
• Lead protocols/reports for new or changes to processes or procedures, as well as investigations related to sterility assurance.
• Qualify instruments, validate QC laboratory methods, evaluate new materials/products, and establish testing standards.
• Manage calibration and maintenance of equipment, lab supplies inventory, and vendor coordination, including POs and budgeting.
• Assist with inspection readiness and act as department SME during audits/regulatory inspections.
• Utilize electronic systems, such as document/equipment management software, QMS, LIMS, and ERP, and may administer laboratory software systems.
• Author, review, and act as document owner for procedure changes, leading on change controls, CAPAs, and quality system requirements.

Requirements:

• Bachelor's degree in Microbiology, Biochemistry, Biological Sciences, or a related field; Master's degree preferred.
• Minimum 5 years of experience in a microbiology laboratory, within the pharmaceutical or radiopharmaceutical industry.
• Familiarity with regulatory requirements and guidelines (e.g., FDA, EMA, USP, EP).
• Experience performing bioburden and sterility tests, and environmental monitoring using EM Total Particulate/Viable monitors.
• GMP compliant manufacturing following ALCOA+ principle and 21 CFR 211 guidelines highly preferred.
• Radioactive material handling of gamma, beta, and alpha emitters experience preferred.

Benefits:

• Competitive salary: $120,000 - $150,000 per annum.
• Opportunities for professional growth and development.
• A dynamic and collaborative work environment.

Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment, prohibiting discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression.