Microbiology Scientist I: Aseptic Testing & Bioburden

RiseMe; Charleston (SC); On-site; USD 60,000 - 80,000; Full time

Job summary

Alcami is seeking a Scientist I (Microbiology) to perform complex microbial analyses and testing in a fast-paced sterile manufacturing environment. The role emphasizes sterility testing using isolators, microbial identification (MicroSeq), and endotoxin testing with a 96-well reader.

Ideal candidates will have 2+ years in biology/microbiology with hands-on GMP experience and a strong foundation in bioburden, growth promotion, and method validation.

Qualifications

• Bachelor’s degree in Biology, Microbiology or similar field with 2+ years related experience.
• Or Associates degree in Biology or related field with 6+ years related experience.
• Experience in sterility testing using an isolator and microbial genetic identification (MicroSeq) is highly desirable.

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, in-process bioburden, kinetic endotoxin, sub-visible particulate matter testing, microbial in-use studies, media fill qualifications.
• Isolates and cultures bacteria or other microorganisms in prescribed media.
• Examines physiological, morphological, and cultural characteristics to identify microorganisms.
• Manages incubation of samples, plate reading and reporting of results; completes GMP reviews as assigned.
• Maintains knowledge of instrumentation and scientific methodologies; documents testing results in the ELN.
• Uses ERP to track project progress and samples through the chain-of-command system.
• Participates in training and maintains certifications; revises procedures as requested.
• Ensures testing documentation adheres to company policies; supports laboratory safety and housekeeping.

Skills

Aseptic Technique

Kinetic Endotoxin Testing

Microbial Examination

Method Validation

Growth Promotion Testing

Media Fill Support

Sub-visible Particulate Testing

GMP Knowledge

MS Office

Microbial Taxonomy

Education

Bachelor’s degree in Biology or Microbiology

Associates degree in Biology or related field

Job description

Alcami is seeking a Scientist I (Microbiology) to perform complex microbial analyses and testing in a fast-paced sterile manufacturing environment. The role emphasizes sterility testing using isolators, microbial identification (MicroSeq), and endotoxin testing with a 96-well reader.

Ideal candidates will have 2+ years in biology/microbiology with hands-on GMP experience and a strong foundation in bioburden, growth promotion, and method validation.