Microbiology Scientist I — Sterility & Endotoxin Testing

Alcami Corporation; Charleston (SC); Hybrid; USD 55,000 - 75,000; Full time

Job summary

Alcami Corporation's Microbiology Laboratory is seeking a Scientist I to perform complex microbial analyses in a fast-paced sterile manufacturing support role. The position emphasizes aseptic technique, isolator-based sterility testing, microbial identification via MicroSeq, and endotoxin testing using a 96-well reader.

The candidate will contribute to method development, validation, and GMP-compliant documentation, with on-site duties and a 1st shift schedule.

Qualifications

• Bachelor’s degree in Biology, Microbiology or related field with 2+ years related experience, or an Associates degree with 6+ years related experience.
• Experience in sterility testing using an isolator and performing microbial genetic identification (MicroSeq); experience with kinetic endotoxin testing using a 96-well plate reader.
• Proficiency with GMP regulations, aseptic technique, and documentation practices; able to perform testing and maintain electronic records and ERP tracking.

Responsibilities

• Demonstrates strict aseptic technique in sample handling and testing.
• Performs microbiological testing of raw material, in-process and finished product samples including microbial examination and bioburden testing.
• Isolates and cultures bacteria or microorganisms in prescribed media with control of moisture, aeration, temperature, and nutrition.
• Examines organisms to identify and classify them using microscopy and other relevant equipment.
• Manages incubation, plate reading and reporting of results; completes GMP reviews as assigned.
• Maintains knowledge of instrumentation and methodologies; documents results in the ELN.

Skills

Aseptic Technique

Kinetic Endotoxin Testing

Microbial Examination

Method Validation

Growth Promotion Testing

Media Fill Support

Particulate Matter Testing

GMP Regulations

MS Office

Microbial Taxonomy

Education

Bachelor’s degree in Biology or Microbiology

Associates degree in Biology

Tools

MicroSeq

96-well plate endotoxin reader

Job description

Alcami Corporation's Microbiology Laboratory is seeking a Scientist I to perform complex microbial analyses in a fast-paced sterile manufacturing support role. The position emphasizes aseptic technique, isolator-based sterility testing, microbial identification via MicroSeq, and endotoxin testing using a 96-well reader.

The candidate will contribute to method development, validation, and GMP-compliant documentation, with on-site duties and a 1st shift schedule.