Pay Range: $80,000-$100,000


Key Responsibilities

Research & Development

• Serve as the subject matter expert (SME) in microbiology and sterilization, supporting both new product initiatives and improvements to existing offerings.

• Provide strategic guidance on timelines, budgets, deliverables, and compliance with regulatory and industry standards to ensure successful product development.

• Design and execute innovative microbiological strategies that align with project goals and regulatory requirements.

• Offer technical leadership in microbiology and sterilization practices to development and engineering teams.

• Oversee sterilization cycle development, validation, requalification, and implementation for specific products.

Laboratory Operations

• Perform testing and analysis to ensure compliance and sterility of products through accurate sample preparation, sterilization, and data review.

• Optimize laboratory workflows and physical layout to improve efficiency and throughput.

• Develop, enhance, and apply advanced analytical methods and instrumentation to ensure reliable testing outcomes.

• Draft, update, and maintain standard operating procedures (SOPs), address process inefficiencies, and drive continuous improvement initiatives.

• Maintain meticulous documentation and collaborate across functions to support compliance and operational goals.

Cross-Functional Collaboration

• Partner with formulation teams to determine appropriate sterilization methods and dosing requirements for sterile product development.

• Collaborate with packaging and operations teams to ensure required sterility assurance levels are achieved.

• Assess technical risks and project hurdles; develop and implement mitigation strategies.

• Lead problem-solving efforts, proactively manage project risks, and align stakeholders around shared objectives and timelines.

• Present technical findings and documentation in team meetings and cross-functional forums.

• Support development of regulatory strategies related to sterilization validation and compliance.

Performance Expectations

• Build strong collaborative relationships with product development and regulatory teams.

• Clearly communicate scientific principles and contribute to project success.

• Manage competing priorities and adjust plans based on evolving business needs.

• Foster transparent communication and alignment across departments.

• Apply deep scientific expertise to deliver measurable impact.

• Exhibit ownership, initiative, and accountability for project outcomes.

Qualifications

Education

• Bachelor’s degree in microbiology, biology, or a related life science is required.

• Master’s or Ph.D. degree is preferred.

Experience & Knowledge

• Demonstrated experience in a regulated research and development environment supporting product innovation.

• Solid expertise in microbiology and sterilization methods.

• Knowledge of FDA or other relevant regulatory frameworks is advantageous.

• Minimum 5 years of experience in sterilization or microbiology within a regulated industry.

• Proficiency with sterilization standards, including Ethylene Oxide, Dry Heat, Gamma, and X-Ray sterilization.
  
  This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
  
  INDBH