Scientist I - Microbiology
About the role
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Scientist I (Microbiology) is accountable for driving results in a fast-paced environment by performing complex microbial analysis and performing microbiological testing to support Alcami’s sterile manufacturing facility as well as external clients. Alcami is especially interested in candidates with experience in sterility testing using an isolator, experience in microbial genetic identification, using a MicroSeq and experience with kinetic endotoxin testing using a 96-well plate reader. Additional areas of desired knowledge and experience include growth promotion testing and microbial method development and validation. The Scientist I (Microbiology) may assist in providing problem solving support and Laboratory Investigation Report ownership for the Microbiology Department.
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 makes cultures of bacteria or other microorganisms in prescribed media, controlling moisture, aeration, temperature, and nutrition.
- Examines physiological, morphological, and cultural characteristics, using microscope and other relevant equipment, to identify and classify microorganisms in test articles.
- Manage the incubation of samples, plate reading and reporting of results.
- Accurately completes GMP reviews as assigned.
- Maintains working knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks.
- Utilizes company Electronic Lab Notebook system to perform and document testing and results.
- Utilizes company tools to track progress of projects through company Enterprise Resource Planning (ERP) system and track samples through company chain-of-command software.
- Participates in company training and maintains current status of certifications.
- Reviews and revises procedures as requested.
- Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
- Assist in sustaining of the laboratory safety and