Scientist II - Microbiology

 

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

On-Site Expectations

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:30am - 5:00pm.

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.
• Performs tests on water, test articles and the environment to detect harmful microorganisms and to obtain information on types and levels of microbial contamination.
• Studies impact of microorganisms on products and evaluate impact of microbial control strategies on microorganism survival.
• Performs assigned tasks carefully and on schedule according to standard operating procedure and supervisor instructions.
• Analyzes information for technical correctness and accuracy.
• Complies with applicable GMPs, peer checks information and signs for GMP review. Brings aberrant information to the attention of supervisor.
• Maintains a safe, clean, and organized work environment free of safety hazards.
• Suggests improvements for safety, work quality, and productivity.
• Seeks to cultivate mentorship, build leadership skills, and fosters a culture of ‘team first.’
• Other duties as assigned.

Qualifications

• Masters degree in Biology, Microbiology or similar field with 0+ years related experience.
• Bachelor’s degree in Biology, Microbiology or similar field with 4+ years related experience.OR
• Associates degree in Biology or related field with 10+ years related experience.

Knowledge, Skills, and Abilities

• Strong Aseptic Technique.
• Strong knowledge of Sterility Testing within an isolator (USP<71>), including traditional and rapid methods.
• Strong knowledge of Microbial Identification using a genetic sequencer.
• Strong knowledge Kinetic Endotoxin Testing using 96-well plate readers and Multi-Cartridge Systems (USP <85>).
• Strong knowledge of Microbial Examination and In-Process Bioburden Testing (USP<60>, <61> & <62>).
• Strong knowledge off Method Validation of endotoxin, sterility, microbial examination.
• Strong knowledge of Growth Promotion Testing.
• Strong Media Fill Support technique.
• Sub-visible Particulate Matter Testing (USP<787>, <788> & <789>).
• Strong knowledge of GMP regulations.
• Strong working knowledge of Microsoft Office applications.
• Strong familiarity with classes of organisms.
• Strong knowledge of microbial taxonomy procedures.
• Ability to recognize deviations from procedures and need for investigations. Good working knowledge of ERP project status and time entry functions.
• General working knowledge of applicable lab standard operating procedures.
• Able to perform routine microbiological test procedures with supervision.
• Strong understanding of proper documentation practices.
• Excellent knowledge of use of lab equipment and some more complex equipment with assistance.
• Accurately executes procedures as written.

 

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.