Microbiologist II

Job Description:

• This microbiologist role will have a strong background in performing method development, method validation, and method transfer activities; as well as routine testing of raw materials, in-process testing and finished product. This exciting role will support microbiological activities for the Glaukos organization, which includes R&D as well as commercial manufacturing.
• The candidate must have experience in cGMPs, regulatory body requirements and FDA compliance. The candidate must be proficient in microbiological testing per USP/EP/JP and other industry regulations/guidance’s (e.g. ISO, AAMI, FDA etc.)
• The ideal candidate would be versatile, flexible, recognize the importance of timely completion, schedules and prioritizes tasks effectively and executes project deliverables to meet project goals and milestones for a successful outcome.

Responsibilities:

• Develop and implement microbiological strategies and procedures to ensure compliance with industry standards and regulations
• Perform method development, feasibility and validation of raw materials, in-process and final product
• Conduct routine microbiological testing and analysis of samples, ensuring accuracy and reliability of results
• Perform routine and stability testing of GLP and GMP supplies
• Write and revise SOP’s, validation protocols/reports, test methods etc.
• Perform testing as needed to generate data for validation and special projects
• Make recommendations and validate new laboratory equipment (e.g., Installation Qualification, Operational Qualification (IQOQ), and Performance Qualification (PQ)
• Maintain accurate and up-to-date documentation of all microbiological activities, including test results, procedures, and reports
• Review and interpret test results, prepare reports, and communicate findings to relevant stakeholders
• Identify and implement improvements to existing microbiological processes, methods, and techniques to enhance efficiency and productivity
• Collaborate with cross-functional teams, such as quality assurance, research and development, and production, to support product development and continuous improvement initiatives
• Stay updated with the latest advancements and trends in the field of microbiology and recommend and implement new technologies and methodologies as appropriate
• Ensure compliance with relevant regulatory requirements and standards, such as Good Manufacturing Practices (GMP), Hazard Analysis and Critical Control Points (HACCP), and ISO standards

Required Skills:

• Proficiency in microbiological techniques such as aseptic testing, microbial monitoring, gram staining, and plating
• Proficiency in aseptic techniques
• Proficiency in microbiology testing according to AAMI/ISO/USP Standards
• Knowledge and control of laboratory equipment including calibration and maintenance
• Ability to understand and perform all required tasks by adhering to company Standard Operating Procedures and all current Good Manufacturing Practices
• Understanding of quality systems including change control, deviations and CAPAs
• Strong written and verbal language skills to effectively read and write SOP’s and related lab reports and communicate with personnel at all levels in the organization
• Excellent teamwork skills, organizational skills, and strong attention to detail
• Excellent analytical and problem-solving abilities to interpret test results, troubleshoot issues, and recommend solutions
• Good understanding of regulatory requirements and industry standards related to microbiology
• Proficient in using microbiological testing equipment and software
• Effective written and verbal communication skills, written and verbal to present findings, reports, and recommendations to various stakeholders
• Attention to detail and high level of accuracy in performing microbiological tests and analysis
• Ability to work collaboratively in cross-functional teams and adapt to changing priorities and deadlines
• Strong organizational and time management skills to prioritize tasks and meet project timelines
• Ability to handle multiple tasks concurrently and complete tasks in a timely manner

Minimum Required Qualifications:

• Bachelor's degree in Microbiology, Biology or related scientific field
• Minimum 5 years of related pharmaceutical experience in a cGMP environment

Physical Requirements:

Ability to lift 25 lbs.

Ability to stand or sit 8 or more hours a day