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, recognized industry expertise, and a proven regulatory track record. The Scientist I (Microbiology) drives results in a fast-paced environment by performing complex microbial analysis and microbiological testing to support Alcami’s sterile manufacturing facility and external clients. We are especially interested in candidates with experience in sterility testing using an isolator, microbial genetic identification (MicroSeq), and kinetic endotoxin testing using a 96-well plate reader. Additional desired experience includes growth promotion testing and microbial method development and validation. This role may also assist in problem-solving support and Laboratory Investigation Report ownership for the Microbiology Department.

Schedule

100% on-site position. 1st Shift: Monday - Friday, 8:30 AM - 5:00 PM.

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, sterility testing, sub-visible particulate matter testing, microbial in-use studies, and media fill qualifications.
• Isolates and cultures bacteria or other microorganisms in prescribed media, controlling moisture, aeration, temperature, and nutrition.
• Examines physiological, morphological, and cultural characteristics using microscopes and other relevant equipment to identify and classify microorganisms in test articles.
• Manages 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 the company Electronic Lab Notebook system to document testing and results.
• Uses company tools to track project progress via the Enterprise Resource Planning (ERP) system and samples through chain-of-command software.
• Participates in company training and maintains current certifications.
• Reviews and revises procedures as requested.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Assists in sustaining laboratory safety and cleanliness by maintaining inventory, disposing of waste, and routine cleaning of laboratory rooms and equipment.
• Ensures required testing documentation is complete and adheres to company policies and procedures.
• Other duties as assigned.

Requirements

• Bachelor’s degree in Biology, Microbiology, or a similar field with 2+ years of related experience.
• OR Associate’s degree in Biology or a related field with 6+ years of related experience.

Skills

• Aseptic Technique.
• Sterility Testing within an isolator (USP), including traditional and rapid methods.
• Microbial Identification using a genetic sequencer (e.g., MicroSeq).
• Kinetic Endotoxin Testing using 96-well plate readers and Multi-Cartridge Systems (USP).
• Microbial Examination and In-Process Bioburden Testing (USP).
• Method Validation of endotoxin, sterility, and microbial examination.
• Growth Promotion Testing.
• Media Fill Support.
• Sub-visible Particulate Matter Testing (USP).
• Familiarity 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 the need for investigations.
• Decision-Making: Ability to act decisively using information and resources to reach informed conclusions.
• Initiative: Takes action to drive efficiencies and recognize areas for continuous improvement.
• Independent: Can execute routine testing with little to no supervision and complex methods with supervision, seeking guidance when necessary.
• Collaboration: Works with microbiology, environmental monitoring, chemistry, and manufacturing teams to plan and execute tasks.
• Organization: Plans ahead for tasks, ensures resources are available, and follows through to timely completion.

Travel Expectations

Up to 5% travel required.

Physical Demands and Work Environment

The physical demands described are representative of those required to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

• Regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear; and smell.
• Frequently required to stand.
• Occasionally required to walk; sit; stoop, kneel, crouch, or crawl.
• Must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, and occasionally lift and/or move up to 50 pounds.
• Specific vision abilities required include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
• Frequently exposed to moving mechanical parts and risk of electrical shock, burn hazards, and microbial contamination.
• Occasionally exposed to fumes or airborne particles, toxic or caustic chemicals, and vibration.
• The noise level in the work environment is usually moderate.
• Required to wear appropriate personal protective equipment (PPE), which may include safety eyewear, respirators, lab coats, full protective body coverings, and gloves.