Quality Control Microbiologist

Responsibilities

• Design, qualify, and implement microbiological test methods for environmental monitoring, water systems, raw materials, and product testing.
• Participate in the selection, qualification, and validation of microbiological laboratory equipment and methods.
• Author SOPs, protocols, and validation documents related to microbiological testing and Contamination Control Strategy (CCS).
• Perform and interpret microbiological tests, including environmental monitoring, sterility testing, bioburden, endotoxin, growth promotion, and microbial identification.
• Maintain compliant laboratory operations, including media management, equipment calibration, qualification, laboratory data integrity and follow biosafety and radiological safety requirements.
• Lead or support development and implementation of a comprehensive site-specific CCS in collaboration with cross-functional stakeholders.
• Lead risk assessments for contamination sources and recommend mitigation strategies throughout facility design and commissioning.
• Serve as the subject matter expert (SME) for regulatory audits and internal inspections focused on microbiological controls.
• Independently assess and troubleshoot complex microbiological issues, proposing and implementing corrective/preventive actions as needed.
• Train QC and Operations staff in aseptic techniques and microbiology best practices.
• Balance Quality requirements with safety, such as biosafety and radiation safety, in all Quality initiatives.

Qualifications and Skills

• Bachelor's degree in Microbiology, Biology, or related life sciences discipline (or equivalent experience).
• Minimum 5 years of QC Microbiology experience in pharmaceutical, radiopharmaceutical, biologics, or similarly regulated GMP environments.
• Strong knowledge of aseptic technique, microbial testing methods, environmental monitoring, and contamination control principles.
• Experience with GMP Quality Systems (investigations, CAPA, change control, audit readiness).
• Familiarity with regulatory expectations including FDA, ICH, and EU Annex 1.
• Ability to work independently in a fast-paced or startup environment.
• Strong attention to detail, with the ability to interpret federal regulations, guidance, and standards.
• Incorporate relevant requirements into TPI documentation and provide guidance to personnel regarding compliance.
• Excellent written and verbal communication skills, including technical writing proficiency and executive-level reporting abilities.
• Strong independent troubleshooting, analytical, problem-solving skills and decision-making skills, such as those developed in fast-paced environments, and other nuclear or radiopharmaceutical environments is highly preferred.
• Occasional evening or weekend work might be required to support production operations or project deliverables.
• The successful candidate will possess a high degree of trust and integrity, communicate openly, and display respect while fostering teamwork.
• Experience in radiopharmaceutical or nuclear medicine manufacturing environments (preferred).
• Experience with facility startup, cleanroom commissioning, or labs built from the ground up (preferred).
• Prior participation in regulatory inspections as a microbiology SME (preferred).
• Experience with rapid microbiological methods or automated microbial identification systems (preferred).
• Certification in Quality (e.g., ASQ), Lean Six Sigma, or project management (preferred).

Job Functions

• Motor Abilities: Sitting for extended periods, bending/stooping, grasping/gripping, fine motor control (hands)
• Physical exertion and/or requirements: Minimal, with ability to safely lift up to 25 pounds
• Repetitive work: Prolonged
• Special Senses: Visual and audio focused work
• Work Conditions: Stairs, typing/keyboard, standard and/or sitting working environment of >8 hours/day
• Travel required 10-20%

Benefits

• Competitive Compensation
• Comprehensive Medical and Wellness Benefits
• Medical Vision
• Dental
• Life and Disability
• Gender Affirmation Benefits
• Parental Leave
• 401k Plan
• Generous Paid Time Off (PTO)
• Generous Holiday Schedule
• Relocation Assistance
• Professional and Educational Support Opportunities