Microbiologist

Overview:

Research and Development:

• Serve as a sterilization and microbiology subject matter expert (SME) to support the development of new products and modifications to existing commercial products.
• Provide guidance to product development teams on project scheduling, budget estimates, and deliverables to ensure successful product launches and adherence to relevant regulations and industry standards.
• Develop innovative microbiology solutions to support product development and meet regulatory requirements.
• Offer technical expertise to product development and engineering teams, leveraging sterilization theory and scientific practices across various fields.
• Lead sterilization cycle development, validation, requalification, and product-specific sterilization qualifications and adoptions.

Laboratory Support:

• Analyze samples, ensure compliance, and meticulously prepare, sterilize, and evaluate products.
• Optimize laboratory space to ensure efficient workflow.
• Develop and refine testing methods using various techniques and instrumentation to achieve precise results.
• Create new SOPs when necessary and maintain continuous improvement through SOP version revisions.
• Maintain detailed records and collaborate with teams to ensure compliance and operational efficiency.

Cross-Functional Support:

• Lead formulators to determine the appropriate method and dosage for sterile products.
• Work with packaging and operations teams to ensure correct sterility assurance levels.
• Identify and assess technical and project risks.
• Drive rapid problem-solving and manage risks, ensuring team alignment on project objectives.
• Prepare and deliver technical reports and presentations for internal meetings.
• Contribute to regulatory strategies related to sterilization validation and verification.

Performance Measurements:

1. Demonstrated ability to collaborate effectively with product development and regulatory teams.
2. Ability to communicate scientific findings clearly and contribute meaningfully to projects.
3. Support work stream timelines and balance priorities based on stakeholder needs.
4. Effective communication and collaboration with team members and cross-functional teams.
5. Show scientific excellence and add value to the organization.
6. Take ownership of assigned projects and independently lead initiatives.

Qualifications:

• Bachelor’s degree in Biological Science required.
• Master’s or Ph.D. is an advantage.
• Previous experience in a regulated R&D environment, particularly supporting sterile products.
• Strong understanding of microbiology.
• Familiarity with FDA regulations.
• Minimum of 5 years' experience in sterilization or microbiology for regulated products.
• Responsible for ensuring compliance with standards governing Ethylene Oxide, Dry Heat, X-Ray, and Gamma sterilization.
• Experience working in GxP laboratory settings.
• Exceptional communication skills, both verbal and written, with the ability to explain scientific concepts to management.
• A prudent risk-taker, identifying opportunities and taking calculated risks to achieve objectives.
• Ability to simplify complex ideas, collaborate effectively, and deliver results.