Microbiology Manager

Penn Life Sciences; Langhorne (Bucks County); Presencial; USD 110.000 - 150.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401(k) with company match

Health, vision, and dental Insurance

Childcare expense reimbursement

Tuition reimbursement

Annual bonus eligibility

Annual merit increases

Paid Time Off and Flexible Holidays

Descripción de la vacante

Penn Life Sciences, Inc. in Langhorne, PA seeks a Microbiology Manager to act as SME and coordinate critical quality control projects, including MLT, bioburden, endotoxin, sterility testing, TAMC, and coliform detection. You will drive ISO-compliant testing and method validation in a regulated environment.

The role also requires maintaining QMS per 21 CFR Part 11, leading CAPA investigations, and supervising 5 microbiologists to ensure product quality and regulatory readiness.

Formación

• Bachelor’s degree in Biological Sciences, Biochemistry, or Microbiology; 2 years experience.

Responsabilidades

• Lead SME for microbiological quality control projects (MLT, bioburden, endotoxin, sterility, TAMC, coliform detection).
• Perform method validation on BET for materials and finished products; conduct testing under ISO-5/6/7/8.
• Maintain QMS within Master Control; ensure 21 CFR Part 11 compliance and regulatory audits.
• Lead investigations and CAPA; supervise 5 microbiologists.

Conocimientos

BET

Bioburden testing

Aseptic processing

QMS

OOS/OOT

ISO-5/6/7/8

Vitek 2

Educación

Bachelor’s degree in Biological Sciences

Herramientas

Vitek 2 analyzer

Descripción del empleo

Microbiology Manager (Langhorne, PA) – Act as Subject Matter Expert (SME) and lead coordinator for critical microbiological quality control projects, including Microbial Limit Testing (MLT), bioburden tests, bacterial endotoxin testing, sterility testing, Total Aerobic Microbial Count (TAMC), coliform detection, endotoxin challenge recovery evaluations, OOS/OOT investigations, and biological indicator performance verification testing; Lead in critical analysis of quantitative and qualitative microbiological testing of pharmaceutical drug products and raw materials in compliance with FDA/GMP, using aseptic processing techniques; Perform method validation on Bacterial Endotoxin Testing (BET) for raw materials, packaging materials and pharmaceutical finished drug products; Perform Microbial Limit and Bioburden tests using Vitek 2 analyzer; Execute EMPQ and gowning qualification programs in compliance with ISO-5/6/7/8; Conduct sterility testing within validated BioQuell Isolators under strict aseptic conditions to ensure product sterility assurance levels; Maintain the Quality Management System (QMS) within Master Control, ensuring compliance with 21 CFR Part 11 and regulatory audits; Lead investigations and root cause analyses of laboratory deviations and nonconformances, using CAPA; Supervise 5 Microbiologists.

Must have bachelor’s degree in Biological Sciences, Biochemistry, or Microbiology plus 2 years experience in job offered. Require skills and working knowledge of BET, MLT/Bioburden Tests, ISO-5/6/7/8, EMPQ, method validation, QMS, OOS/OOT, Aseptic Processing.

Job location: Langhorne, PA.

• 401(k) with company match
• Health, vision, and dental Insurance
• Childcare expense reimbursement
• Tuition reimbursement
• Annual bonus eligibility
• Annual merit increases
• Paid Time Off and Flexible Holidays