Analytical and Microbiological Quality Control Lead

Genezen5 months ago

Indianapolis, IN, United States

Hybrid

Full-time

Junior Level (1-3 years)

Job Description

Genezen is seeking a leader for their Analytical and Microbiological Quality Control (QC) laboratories. This role involves providing scientific and technical expertise for all QC activities, supporting Analytical Development for method qualification/validation, and serving as the facility's aseptic subject matter expert.

Responsibilities:

Ensuring timely testing of biopharmaceuticals
Maintaining familiarization with various analytical and bioassay methods for viral vectors
Managing the environmental monitoring program
Developing EM trending programs
Implementing an in-house isolates program
Overseeing disinfectant efficacy
Managing laboratory equipment and software
Supporting method qualification/transfers
Representing QC in client meetings
Establishing stability programs
Overseeing LIMS development
Managing laboratory logistics
Handling external contracts
Supporting investigations
Analyzing regulatory guidelines
Presenting operational metrics
Participating in audits
Leading team development
Ensuring compliance

Required Skills

Environmental Monitoring Program Management

LIMS Development

Client Communication

Analytical Development

Laboratory Equipment Management

Team Leadership

Operational Metrics Analysis

Audit Participation

Aseptic Technique

Method Qualification/Validation

Regulatory Compliance

Disinfectant Efficacy Testing