Associate Scientist - Microbiology; Wed-Sat (4x10s)

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 a proven regulatory track record.

About the Role

The Associate Scientist - Microbiology is accountable for driving results in a fast-paced environment by performing complex microbial analysis and microbiological testing to support Alcami’s sterile manufacturing facility as well as external clients. This role may also assist in providing problem-solving support and Laboratory Investigation Report ownership for the Microbiology Department.

Schedule

• 1st Shift: Wednesday - Saturday, 8:00am - 6:30pm
• 100% on-site position

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.
• Tracks progress of projects through the company Enterprise Resource Planning (ERP) system and samples through 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.
• Assists in sustaining laboratory safety and cleanliness by maintaining inventory, disposal of waste, and routine cleaning of laboratory rooms and equipment.
• Ensures required testing documentation is complete and generated with adherence to company policies and procedures.
• Other duties as assigned.

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.

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 come to informed conclusions.
• Initiative: Recognizes areas for continuous improvement and takes action to drive efficiencies.
• Independent: Can execute routine testing with little to no supervision and more complex methods with supervision.
• Collaboration: Works with microbiology, environmental monitoring, chemistry, and manufacturing personnel to plan and execute tasks.
• Organization: Utilizes organizational skills to plan ahead, ensure resources are in place, and follow tasks through to timely completion.

Travel Expectations

Up to 5% travel required.

Physical Demands and Work Environment

• 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 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) such as safety eyewear, respirators, lab coats, full protective body coverings, and gloves.