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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.
Are you interested in joining our team?
Job Summary:
The Sr. Scientist I, Microbiology is accountable for driving results in a fast-paced environment by performing more complex microbial analysis and assisting in method development and validation. This position takes on the role of troubleshooter and trainer and will provide direct assistance to manufacturing and cleanroom qualification efforts. The Sr. Scientist I, Microbiology participates more actively in lab investigations and corrective and preventative actions. The role initiates procedural revisions and performs editing and review functions. The Sr. Scientist I, Microbiology may serve as a primary technical contact with clients.
On-Site Expectations:
- 100% on-site position.
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1st Shift: Monday - Friday, 8:00am - 5:30pm.
Responsibilities:
- Experience in supporting aseptic manufacturing or clean room ISO100 operations.
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Experience with sterilization processes both steam and VHP.
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Maintains advanced knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned task.
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Performs assigned tasks carefully and on schedule according to standard operating procedure and supervisors’ instructions.
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Isolates and makes cultures of bacteria or other microorganisms in prescribed media, controlling moisture, aeration, temperature, and nutrition.
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Performs tests on water, test articles and the environment to detect harmful microorganisms and to obtain information on types and levels of microbial contamination.
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Examines physiological, morphological, and cultural characteristics, using microscope and other relevant equipment, to identify and classify microorganisms in test articles.
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Studies impact of microorganisms on products and evaluate impact of microbial control strategies on microorganism survival.
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Prepares technical write up and assist in report generation as needed. Offer conclusions and recommendations based upon study outcomes.
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Accurately completes GMP reviews.
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Participates actively in lab investigations and corrective and preventative actions.
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Trains others on individual core technologies.
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Interacts with clients.
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Initiates procedural revisions and perform editing and review functions.
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Performs method development and validation independently.
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Participates in process improvements.
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Participates in company training and maintains current status of certifications.
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Complies with applicable GMPs.
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Provides technical training and leadership for subordinate technical positions.
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Maintains a safe, clean, and organized work environment free from safety hazards.
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Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
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Other duties as assigned.
Qualifications:
- Bachelor’s degree in Biology, Microbiology, or related field with 8+ years of experience, a master’s degree with 4+ years of experience or a PhD with 2+ years of experience is required.
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Prior pharmaceutical or CDMO experience required.
Knowledge, Skills, and Abilities:
- Proficiency in any or all of the following: , USP<60>, <61>, <62>, <1119> (Microbial Examination), USP<55> (Biological Indicators), USP <56> (Methods for Determination of Resistance of Microorganisms to Sterilization, USP<85> (Bacterial Endotoxins Testing), Growth Promotion of Media, – required.
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Understanding of USP <71> (Sterility Testing using an isolator), USP <788> Particulate Matter in Injections
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Ability to perform lab investigations, microbial risk assessments, and corrective and preventative actions a plus.
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Excellent verbal and written communication and documentation skills required.
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Excellent detail orientation and organizational skills required.
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Excellent problem-solving and basic trouble-shooting ability required.
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Excellent knowledge of Laboratory equipment and safety required.
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Excellent knowledge of Laboratory Documentation is required.
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Strong knowledge of cGMP in a pharmaceutical or regulated environment preferred.
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Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.
Travel Expectations:
- Up to 5% domestic travel.
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.
