Sr. 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 Sr. Scientist II is accountable for driving results in a fast-paced environment by performing microbiological routine and non-routine testing in support of pharmaceutical product development or pharmaceutical manufacturing and stability. A Sr. Scientist II will rountinely lead method suitability/method validation projects. Bacterial endotoxins, sterility, microbial examination, and antimicrobial effectiveness based methodologies are commonly employed in the described testing. Other key methodologies applied include liquid particulate matter and genetic identification testing. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company).

On-Site Expectations

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

Responsibilities

• Combination of basic and advanced skills in multiple techniques, to include use of proper aseptic technique, operation of microscope, Gram staining, pH measurement, isolation of pure cultures, understanding of rapid techniques and strong pipetting skills.
• Isolates and makes cultures of bacteria or other microorganisms in prescribed media, controlling moisture, aeration, temperature and nutrition.
• Performs tests on water, test articles and the environment to detect harmful microorganisms and to obtain information on types and levels of microbial contamination.
• Examines physiological, morphological and cultural characteristics, using microscope and other relevant equipment, to identify and classify microorganisms in test articles.
• Studies impact of microorganisms on products and evaluate impact of microbial control strategies on microorganism survival.
• Achieves results by solving problems of a diverse scope.
• Drives initiatives outside of standard work function.
• Writes methods, test procedures, protocols and reports.
• Executes method suitability/validation and routine testing with little to no assistance.
• Maintains working knowledge of routine instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks.
• 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.
• Participates in company sponsored training and maintains current status of certifications.
• Maintains a safe, clean, and organized work environment free of safety hazards.
• Suggests improvements for safety, work quality, and productivity.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Seeks to cultivate mentorship, build leadership skills, and fosters a culture of ‘team first’.
• Other duties as assigned.

Qualifications

• PhD in Biology, Microbiology or related related field with 4+ years of related operational experience.
• Master's degree in Biology, Microbiology or related related field with 6+ years of related operational experience.
• Bachelor's degree in Biology, Microbiology or related related field with 10+ years of related operational experience.
• Prior laboratory experience or work experience in Pharmaceutical, CDMO, or cGMP required.

Knowledge, Skills, and Abilities

• Knowledge of Chemistry and Biology plus course work in Microbiology.
• Basic mathematical functions.
• Strong familiarity with major classes of microorganisms.
• Working knowledge of applicable GMP regulations.
• General computer program operations, inc. Word, Excel, Outlook.
• Advanced theory of microbiology test procedures.
• General working knowledge of ERP project status and time entry functions.
• Working knowledge of applicable lab standard operating procedures.
• Able to perform routine microbiological test procedures without supervision.
• Proper documentation practices.
• Use of basic lab equipment and some more complex equipment with minimal assistance.
• Execute procedures as written.
• Ability to recognize deviations from procedures and need for investigations.
• Excellent aseptic technique.

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 the 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.