Sr. Microbiologist (Contract)
Planet Pharma - Aliso Viejo, CA
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Job DescriptionJob 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 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 regulationsPerform method development, feasibility and validation of raw materials, in-process and final productConduct routine microbiological testing and analysis of samples, ensuring accuracy and reliability of results.Perform routine and stability testing of GLP and GMP suppliesWrite and revise SOP's, validation protocols/reportsPerform 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 reportsReview 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 productivityCollaborate with cross-functional teams, such as quality assurance, research and development, and production, to support product development and continuous improvement initiativesStay updated with the latest advancements and trends in the field of microbiology and recommend and implement new technologies and methodologies as appropriateEnsure compliance with relevant regulatory requirements and standards, such as Good Manufacturing Practices (GMP), Hazard Analysis and Critical Control Points (HACCP), and ISO standardsRequirementsRequired Skills:Proficiency in microbiological techniques such as aseptic testing, microbial monitoring, gram staining, and platingProficiency in testing according to AAMI/ISO/USP StandardsKnowledge and control of laboratory equipment including calibration and maintenanceAbility 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 neededAbility to handle multiple tasks concurrently and complete tasks in a timely mannerStrong 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 organizationExcellent teamwork skills, organizational skills, and strong attention to detail Knowledgeable in regulatory requirements and industry standards related to microbiologyProficient 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 solutionsAbility to work collaboratively in cross-functional teams and adapt to changing priorities and deadlinesStrong organizational and time management skills to prioritize tasks and meet project timelinesMinimum Required Qualifications:Bachelor's degree in Microbiology, Biology or related scientific field Minimum 8 years of related pharmaceutical experience in a cGMP environmentPay $45-57 based on experience Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@, @planet-pharma.co.uk, and @) and not a domain with an alternative extension like .net, .org or .jobs.
Created: 2026-04-15