Associate Scientist - Microbiology - 3rd Shift

Alcami Corporation•North Charleston, SC

4d•Onsite

About The Position

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. The Associate Scientist (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 membrane filtration, pour plates and growth promotion. The Associate Scientist (Microbiology) may assist in providing problem solving support and Laboratory Investigation Report ownership for the Microbiology Department and Method Suitability Development.

Requirements

Bachelor’s degree in Biology, Microbiology, or a related field.
0 - 4+ years of related work experience.
Prior laboratory experience or work experience in Pharmaceutical, CDMO, or cGMP preferred.
Aseptic Technique.
Microbial Subculturing.
Kinetic Endotoxin Testing using Multi-Cartridge Systems (USP <85>).
Microbial Examination and In-Process Bioburden Testing (USP<60>, <61> & <62> <1119>).
Method Validation of endotoxin, sterility, microbial examination.
Growth Promotion Testing.
Media Fill Support.
Familiar with GMP regulations.
General working knowledge of Microsoft Office applications.
Moderate familiarity with classes of organisms.
Basic knowledge of microbial taxonomy procedures.
Ability to recognize deviations from procedures and need for investigations.
Decision-Making: Has the ability to act decisively, using information and resources to come to informed conclusions.
Initiative: Takes the initiative to recognize areas for continuous improvement and takes action to drive efficiencies.
Independent: Can independently execute desired routine testing with little to no supervision, and more complex methods with supervision, asking questions of other team members and management when necessary.
Collaboration: Works with fellow microbiology and environmental monitoring team members, as well as chemistry and manufacturing personnel to plan and execute assigned tasks.
Organization: Utilizes organizational skills to plan ahead for tasks, ensure items are in place to execute the tasks, follows the task through to timely completion.

Nice To Haves

experience in membrane filtration, pour plates and growth promotion

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, 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.
Performs environmental monitoring of manufacturing areas.
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 cleanliness by maintaining inventory, disposal of waste and routine cleaning of laboratory rooms and equipment.
Ensure required testing documentation is complete and generated with adherence to company policies and procedures.
Other duties as assigned.