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Microbiologist I

TPP CDMO · San Diego, CA

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About TPP TechTPP Tech LLC is a US-based pharmaceutical development and manufacturing company operating an FDA-registered drug establishment in San Diego, with more than 30 years of continuous cGMP operation. Our Nancy Ridge campus houses sterile formulation and automated vial filling suites, lyophilization, oral solid dose and liquid manufacturing, and on-site cGMP and GLP analytical laboratories. We are DEA-registered for Schedule IV and V manufacturing and analytical testing.The roleReporting to the Director, Quality, the Microbiologist I performs microbiology and environmental monitoring testing for our parenteral facility. This includes testing of all utilities to US and EU standards (ISO 14644 and EU GMP Annex 1) as well as routine testing supporting non-aseptic operations, alongside general laboratory duties and equipment cleaning. This is an on-site role at our San Diego facility.Essential functionsOther duties may be assigned.Perform microbiology testing of raw materials, active pharmaceutical ingredients, and drug productAssist with environmental monitoring of all ISO classified areas and hoods, utility sampling and testing, and cleanroom scienceExecute product suitability and validation testingMaintain the gowning qualification required to perform work in an ISO classified areaMaintain compliance with company policies and proceduresAssist senior QC microbiology team members with investigations as needed for microbiology testing and environmental monitoringMaintain laboratory equipment and perform general laboratory duties as assigned by the ManagerMeet testing timelines associated with project schedulesSupport training and mentoring of other team membersAssist in developing department protocols and reports; prepare Standard Operating Procedures (SOPs) for approval and initiate revisions to current SOPsDevelop, implement, maintain, and continually assess the company's environmental monitoring and microbiology testing activities to ensure contamination control policies and practices meet internal company standards and external global regulatory requirementsEmbody TPP Tech's cultural values and align daily actions with department and company cultureMaintain regular and reliable attendance on a full-time basisExhibit professional behavior with both internal and external business associates that reflects positively on the company and is consistent with company policies and practicesMentor junior microbiologistsSupport cross-functional training programsEducation and experienceBachelor's degree in a life science, generally with one to two years of relevant experienceKnowledge of aseptic laboratory work and techniquePrevious compendial microbiology testing experience preferredStrong verbal and written communication skills, and working knowledge of Microsoft OfficePhysical demands and work environmentThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing these duties, the employee is frequently required to:Sit, and reach to use computers and other office equipmentStand for extended periods of time, up to four hoursView objects at close and distant ranges with hand and eye coordinationCommunicate effectively with others verbally, in person or on video, and in writingLift up to 20 poundsCompensation$28.00 – $36.00 per hour. This is the pay scale TPP Tech reasonably expects to pay for this position. Actual compensation within the range depends on job-related knowledge, skills, and experience.Equal employment opportunityTPP Tech LLC is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, ancestry, age, disability, medical condition, genetic information, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law.TPP Tech will consider qualified applicants with criminal histories in a manner consistent with applicable law, including the California Fair Chance Act. Any offer of employment is contingent upon successful completion of a post-offer background check and drug screen.