Sr. Scientist I - Microbiology

Alcami Corporation•North Charleston, SC

1d•Onsite

About The Position

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.

Requirements

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.
Prior pharmaceutical or CDMO experience required.
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.
Excellent verbal and written communication and documentation skills required.
Excellent detail orientation and organizational skills required.
Excellent problem-solving and basic trouble-shooting ability required.
Excellent knowledge of Laboratory equipment and safety required.
Excellent knowledge of Laboratory Documentation is required.
Strong knowledge of cGMP in a pharmaceutical or regulated environment preferred.
Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.

Nice To Haves

Understanding of USP <71> (Sterility Testing using an isolator), USP <788> Particulate Matter in Injections
Ability to perform lab investigations, microbial risk assessments, and corrective and preventative actions a plus.

Responsibilities

Experience in supporting aseptic manufacturing or clean room ISO100 operations.
Experience with sterilization processes both steam and VHP.
Maintains advanced knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned task.
Performs assigned tasks carefully and on schedule according to standard operating procedure and supervisors’ instructions.
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.
Prepares technical write up and assist in report generation as needed. Offer conclusions and recommendations based upon study outcomes.
Accurately completes GMP reviews.
Participates actively in lab investigations and corrective and preventative actions.
Trains others on individual core technologies.
Interacts with clients.
Initiates procedural revisions and perform editing and review functions.
Performs method development and validation independently.
Participates in process improvements.
Participates in company training and maintains current status of certifications.
Complies with applicable GMPs.
Provides technical training and leadership for subordinate technical positions.
Maintains a safe, clean, and organized work environment free from safety hazards.
Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Other duties as assigned.