Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

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Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

   

Summary of Objective:

The Microbiologist Team Lead position leads others in a variety of complex tasks under general guidance and in accordance with current GMP/ISO requirements and standards and following all safety Guidelines of PCI.  With general supervision, the microbiologist team lead oversees and performs, when applicable, all day-to-day operations including but not limited to sampling and testing of production environments, lab work, and/or facility clean utilities, as per approved procedures.  Additionally, addresses non routine matters. Utilizes technical knowledge and experience to resolve complex problems.  Escalates matters requiring  resolution by management. Works with, reviews and revises records and standard operating procedures.  Trains and guides less experienced personnel. Is a model of the Guardian values and behaviors. Effectively communicates any issues with upper management to reach business goals effectively.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

Maintains and adheres to safe work habits and all applicable PCI safety procedures and guidelines. Is proactive in identifying safety risks and alerts management to take corrective action.Oversees, performs and provides training for routine Environmental Monitoring of the classified clean roomsOversees, performs and provides training for sampling and test the Water for Injection System, USP Purified Water systems and Clean Steam systems.Oversees, performs and provides training for laboratory work; plate reads and utility testing, growth promotion of mediaAccountable for completing daily tasks and reporting issues to managementMentors less experienced staff in the performance of daily job tasks.Completes training and ensures proper training within the team prior to task assignmentsIdentifies, escalates and documents events that deviate from normal operation; perform investigations as neededPeer review of quality control dataRoutinely performs SOP document changes/updatesPreparation of investigations, reports and execution of complex protocolsVisual inspection of media fill vialsPerform, schedule and oversee general lab maintenance/housekeepingOther duties as assigned

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

Exceptional organizational skills, detail orientedStrong ability to plan and prioritize complex activities to meet goals and objectivesStrong analytical skills to identify risks and prepare balanced decisionsAbility to gown to work in an ISO-5 environmentAbility to work varied hours as required by the production schedulePeople management skillsProfessional verbal communication skills requiredSolid computer skillsWorking/theoretical knowledge of lab equipmentAbility to identify process improvements

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hearAbility to sit or stand for prolonged periods of timeMust be able to walk and drive between locationsPhysically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves Must be able to occasionally lift and/or move up to 50 poundsMust pass eye examComfortable with working/handling of hazardous materialsFollow written instructions.  Perform independent troubleshooting of common issues. Provide expertise for response to complex issues.Able to work in a highly complex environment with competing demands and priorities

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

6-8 years’ experience in a cGMP environment.  Two years of experience may be replaced by Associates/Non- Scientific Bachelor’s degree.  Three years of experience may be replaced with BS/BA degree in Microbiology or related scientific field.High School Diploma required. BS/BA degree in Microbiology or related scientific field preferred.2+ years of cGMP Pharmaceutical experience

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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.