Scientist I - Microbiology - 2nd Shift

Job Summary

The Scientist I (Microbiology) at Alcami is accountable for driving results in a fast-paced environment by performing complex microbial analysis and microbiological testing. Alcami is particularly interested in candidates with experience in sterility testing using an isolator, microbial genetic identification using a MicroSeq, and kinetic endotoxin testing using a 96-well plate reader.

On-Site Expectations

• 100% on-site position
• Second shift: Wednesday - Saturday, 1:30pm - 12:00am

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, 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
• Assists in sustaining of the 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

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
• GMP experience required
• Knowledge, Skills, And Abilities:
• Aseptic Technique
• Sterility Testing within an isolator (USP), including traditional and rapid methods
• Microbial Identification using a genetic sequencer
• 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, microbial examination
• Growth Promotion Testing
• Media Fill Support
• Sub-visible Particulate Matter Testing (USP, & )

Physical Demands and Work Environment

• While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to stand. The employee is occasionally required to walk; sit and stoop, kneel, crouch, or crawl.
• The employee 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 by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
• While performing the duties of this job, the employee is frequently exposed to moving mechanical parts and risk of electrical shock, burn hazards and microbial contamination.
• The employee is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals and vibration.
• The noise level in the work environment is usually moderate.
• The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.