Microbiologist I

6 days ago


East Windsor, United States Empower Pharmacy Full time

Position Summary:
As a Microbiologist I at Empower, you will be a vital contributor to the quality and safety of our medications. Your role is essential in maintaining our high standards through meticulous microbiological testing of raw materials, finished products, and environmental samples. With a focus on our values, people, quality, service, and innovation, you will be utilizing a variety of advanced techniques, including microbial enumeration, identification, and antimicrobial effectiveness testing, to ensure our products meet rigorous quality and safety standards.

In this position, your analytical skills will be crucial as you interpret experimental results using statistical methods and bioinformatics tools, contributing valuable insights to research discussions and project meetings. By documenting procedures, results, and observations meticulously, you will ensure the integrity and reproducibility of our scientific work, preparing technical reports, presentations, and scientific publications for both internal and external audiences.

Your role will also involve developing and validating microbiological test methods, and ensuring compliance with regulatory standards, current Good Manufacturing Practices (cGMP) requirements, and company policies. You will actively participate in internal and external audits and implement best practices and innovative solutions to enhance laboratory efficiency and effectiveness.

At Empower, we are dedicated to producing innovative medications to help people live healthier, happier lives. As a Microbiologist I, your work will be pivotal in achieving this mission, and you will be part of a team that values continuous learning and professional growth. If you are passionate about science and driven by the desire to make a tangible difference, we invite you to join our team and help us expand access to quality, affordable medication.

Duties and Responsibilities:

- Conducts microbiological testing of raw materials, finished products, and environmental samples using a variety of techniques, including microbial enumeration, identification, and antimicrobial effectiveness testing.
- Designs and executes experiments to investigate microbial physiology, genetics, and interactions. Utilizes state-of-the-art laboratory equipment and techniques to collect and analyze data.
- Analyzes experimental results using statistical methods and bioinformatics tools. Interprets findings and contributes insights to research discussions and project meetings.
- Documents experimental procedures, results, and observations in detailed laboratory notebooks.
- Prepares technical reports, presentations, and scientific publications for internal review and external dissemination.
- Adheres to established laboratory protocols, safety guidelines, and regulatory requirements. Maintains a high level of accuracy, precision, and reproducibility in all experimental procedures.
- Collaborates effectively with cross-functional teams, including other microbiologists, engineers, and project managers. Communicate research findings and progress updates in a clear and concise manner.
- Develops and validates microbiological test methods in accordance with compendial and regulatory requirements.
- Maintains accurate and detailed records of all microbiological testing and analysis performed. Prepares and reviews reports, protocols, and standard operating procedures related to microbiological activities.
- Ensures compliance with regulatory standards, cGMP requirements, and company policies and procedures. Participate in internal and external audits as needed.
- Implements best practices and innovative solutions to enhance efficiency and effectiveness.
- Assists with microbiology-related projects, including method transfers, validations, and investigations.
- Identifies opportunities for process improvements and optimization within the microbiology laboratory.
- Performs other duties as assigned.

To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

While performing the responsibilities of the job, the employee is required to talk and hear. Must be able to bend at the waist and knees as well as twist at the trunk. Must be able to lift up to 25 lbs. Must be able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. Personal protective equipment and Respirators are essential for the health and safety of employees. Position requires working in the laboratory as well as sitting Microbiological method development and method validation procedures like BET, Sterility, MLT, BIO Assay and Disinfectant qualification and microbiological hold time validation