Associate Scientist

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.

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Job Summary

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 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 Associate Scientist (Microbiology) may assist in providing problem solving support and Laboratory Investigation Report ownership for the Microbiology Department.

**This is a 1st Shift: Wednesday - Saturday, 8:00am - 6:30pm.

On-Site Expectations

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

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.
• 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.

Qualifications

• 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.

Knowledge, Skills, and Abilities

• Aseptic Technique.
• Sterility Testing within an isolator (USP<71>), including traditional and rapid methods.
• Microbial Identification using a genetic sequencer.
• Kinetic Endotoxin Testing using 96-well plate readers and Multi-Cartridge Systems (USP <85>).
• Microbial Examination and In-Process Bioburden Testing (USP<60>, <61> & <62>).
• Method Validation of endotoxin, sterility, microbial examination.
• Growth Promotion Testing.
• Media Fill Support.
• Sub-visible Particulate Matter Testing (USP<787>, <788> & <789>).
• 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.

Travel Expectations

• Up to 5% travel required.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 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.