Senior Microbiologist

TalentCraft; Aliso Viejo (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

TalentCraft is seeking a Microbiologist to support microbiological activities for Glaukos organization, including R&D and commercial manufacturing. The candidate will develop strategies to ensure compliance with industry standards and regulations, conduct microbiological testing, and maintain accurate documentation.

The ideal candidate will have a Bachelor's degree, a minimum of 8 years of pharmaceutical experience in a cGMP environment, and proficiency in microbiological techniques. Strong organizational skills, attention to detail, and effective communication are essential for success in this role.

Qualifications

• Minimum 8 years of related pharmaceutical experience in a cGMP environment.
• Understanding of quality systems including change control and CAPAs.

Responsibilities

• Develop and implement microbiological strategies and procedures.
• Perform method development, feasibility and validation of products.
• Conduct routine microbiological testing and analysis.

Skills

Microbiological techniques

Aseptic testing

Organizational skills

Attention to detail

Written and verbal communication

Problem-solving abilities

Regulatory knowledge

Education

Bachelor's degree in Microbiology or related field

Tools

Microbiological testing equipment

Microsoft Office programs

Job description

This microbiologist role will have a strong background in performing method development, method validation, 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. The ideal candidate would be versatile, flexible, extremely organized, ability to adapt to project demands and ability to prioritize work to meet timelines. The candidate must have an understanding of aseptic processes and manufacturing.

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
• 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

Requirements

Minimum Required Qualifications

• Bachelor's degree in Microbiology, Biology or related scientific field
• Minimum 8 years of related pharmaceutical experience in a cGMP environment

Required Skills

• Proficiency in microbiological techniques such as aseptic testing, microbial monitoring, gram staining, and plating
• Proficiency in 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; support investigations as needed
• Ability to handle multiple tasks concurrently and complete tasks in a timely manner
• Strong written and verbal language skills to effectively read and write SOP’s and related lab reports and effective communication skills to present data with personnel at all levels in the organization
• Excellent teamwork skills, organizational skills, and strong attention to detail
• Knowledgeable in regulatory requirements and industry standards related to microbiology
• Proficient in using microbiological testing equipment and software; Knowledge and proficiency in computer software (e.g. Microsoft Office programs)
• Attention to detail and high level of accuracy in performing microbiological tests and analysis and excellent analytical and problem-solving abilities to interpret test results, troubleshoot issues, and recommend solutions
• 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