Exela Pharma

Senior Microbiologist

Exela Pharma$75K — $95K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • 5-8 years of relevant laboratory experience
  • Strong understanding of aseptic techniques and cGMP compliance
  • Proven experience in leading investigations and corrective actions (CAPAs)
  • Exceptional leadership, mentoring, and coaching abilities
  • Excellent communication skills and ability to work independently

Responsibilities

  • Lead microbiological testing and troubleshooting efforts
  • Mentor and train junior microbiologists in lab techniques
  • Conduct root cause analysis for microbiological deviations
  • Drive process improvements for laboratory efficiency
  • Serve as microbiology representative during regulatory inspections

Benefits

  • Comprehensive health benefits package
  • Opportunities for professional development and continued education
  • Flexible work environment to balance work-life
  • Involvement in meaningful projects supporting sterile manufacturing operations
  • Participation in impactful continuous improvement initiatives
Full Job Description
Position Summary

The Senior Microbiologist serves as a technical leader within the Microbiology laboratory, responsible for advanced microbiological testing, complex troubleshooting, and oversight of laboratory investigations. This role drives scientific rigor and compliance by leading root cause investigations, owning CAPAs, and executing continuous improvement initiatives.

The Senior Microbiologist is a subject matter expert (SME) in Environmental Monitoring (EM), Water for Injection (WFI), and product-related microbiological testing, and plays a key role in mentoring and developing laboratory personnel while supporting cGMP sterile manufacturing operations.

Job Responsibilities
  • Technical Expertise & Laboratory Leadership
    • Serve as a subject matter expert (SME) for microbiological methods, testing techniques, and equipment.
    • Maintain training and provide technical guidance to Microbiologists on all microbiological testing including product and water bioburden, endotoxin testing, TOC and Conductivity, sterility, and organism identification.
    • Lead and execute complex microbiological testing, method troubleshooting, and atypical result evaluations.
    • Evaluate and improve microbiological methods for robustness, compliance, and efficiency.
    • Support method validations, verifications, and transfers.
  • Investigations, CAPAs, & Quality Systems
    • Lead and own microbiological deviation and laboratory investigations, including thorough root cause analysis.
    • Author and drive corrective and preventative actions (CAPA) to completion against defined timelines, ensuring effectiveness and sustainability
    • Act as primary microbiology representative in investigations impacting manufacturing, utilities, or product quality
    • Execute microbiological change controls for laboratory and manufacturing processes with technical accuracy
  • Process Improvement & Continuous Improvement
    • Lead process improvement initiatives to enhance laboratory efficiency, compliance, and audit readiness
    • Drive risk-based decision making for prioritization
  • Mentorship & Team Development
    • Provide bench-side mentorship, coaching, and technical training to Microbiologists
    • Develop training materials and ensure effective onboarding and ongoing competency development
    • Act as a resource for troubleshooting and scientific problem-solving for the team
  • Regulatory Inspections & Audit Readiness
    • Serve as the primary microbiology representative during regulatory inspections
    • Responsible for ensuring inspection readiness
    • Maintain effective communication with inspectors
    • Drive actions for successful resolution of audit observations or improvements identified.
  • This position may be involved with the transportation and handling of hazardous waste; must successfully complete Resource Conservation Recovery Act (RCRA) training within 1 year of hire, and annually thereafter.

Experience Requirements
  • Minimum of 5-8 years of related laboratory experience, academic or otherwise
  • Knowledge of aseptic techniques
  • Knowledge of cGMP
  • Experience in activities pertaining to aseptic manufacturing and knowledge of how to maintain an aseptic environment
  • Demonstrated experience leading investigations, CAPAs, and root cause analysis
  • Strong leadership, mentoring, and coaching skills
  • Ability to multi-task, work under pressure with time constraints
  • Must be flexible and able to adapt to changes in task priority
  • Excellent communication skills and ability to work independently to complete tasks


Education Requirements

  • Bachelor of Science (BS) Degree in Microbiology, Biology, or related Life Sciences.

About Exela Pharma

Exela Technologies, Inc. is an American business process automation company. It was created with the merger of SourceHOV LCC, Novitex Holdings, Inc. and Quinpario Acquisition Corp. 2. Exela’s software and services include multi-industry department solution suites addressing finance & accounting, human capital management, and legal management, as well as industry-specific solutions for banking, healthcare, insurance, and public sectors. Exela Technology services include workflow automation, digital mail rooms, attended and un-attended cognitive automation, print communications, and payment processing. In 2018 the company declared serving 3,500 customers in more than 50 countries. It has 1,100 onsite client facilities and 150 "delivery centers" in the Americas, Europe and Asian continent. In June 2018, Exela Technologies was listed as a major contender in the Everest Group – "Know your customer-Anti Money Laundering BPO – State of the Market with PEAK Matrix Assessment 2018". In July 2019, Exela Technologies added Martin Akins to their board of directors. In March 2020, Exela completed the divestment of SourceHOV Tax, the company's tax consulting group, for $40 million to private equity firm Gainline Capital Partners. Greenlight Capital is one of the top investors in Exela Technologies. As per the latest financial results published in August 2022, the number of employees stood at approximately 17,500.
Learn more about Exela Pharma

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