Microbiologist

Job Title:Microbiologist

Isotopia is a global biotech company manufacturing key ingredients for pharmaceutical cancer drugs. At our US headquarters in Indianapolis, we will be close by to our key customers, delivering our products just in time, each day, every day. We are seeking a highly motivated and detail-oriented Microbiologist to join our dynamic team. You will play a crucial role in ensuring the safe and efficient production of our products.  You will be part of a family and team, dedicated to our mission to deliver on our covenant with our customers.

Responsibilities:

• Performing microbiological testing of raw materials, in-process materials, and finished product for batch approval and release.

• Development and management of an environmental monitoring program.

• Supporting the development and execution of a microbiological trending program and preparation of periodic reports for the facility.

• Supporting and executing qualifications and validations for microbiological testing equipment and site sterility assurance programs.

• Leading investigations for OOS (out-of-specification) environmental monitoring recoveries and sterility testing and for other issues related to aseptic processing deviations.

• Providing input and support for resolution of facility issues and CAPA (corrective actions/preventive actions).

• Preparing materials and training for aseptic principles and contamination control.

• Performing routine inspections of laboratory notebooks and of the laboratory environment in accordance with written inspection procedures.

• Maintaining inventory of materials required for microbiological testing.

• Assisting with qualification, calibration, and maintenance of EM sampling equipment (viable and non-viable sampling equipment).

• Coordinating sampling plans and shipment of samples to third party labs for any necessary third-party testing.

• Development and implementation of a contamination control plan.

• Performing any other tasks related to analytical testing as necessary.

Requirements

Education and Skills:

• Bachelor’s degree in biology, microbiology, or related life science is required.

• Previous experience with USP microbiological test methods such as sterility and bioburden is preferred.

• Previous experience in pharmaceutical / radiopharmaceutical quality control is preferred.

• Strong understanding of cGMP requirements and radiation safety practices is preferred.

• Detail-oriented mindset with excellent organizational and record-keeping skills.

• Effective communication and teamwork abilities, with a focus on collaborative problem-solving.

• Ability to work in a regulated and fast-paced environment while maintaining a high level of accuracy.

• Flexibility to work in shifts and handle time-sensitive processes.

• Strong commitment to safety, ethical conduct, and compliance with regulations.

• Physical ability to stand for extended periods, lift moderately heavy objects up to 50 pounds, and to handle frequent stooping and crouching, and wear appropriate PPE.

Benefits

Isotopia USA offers a comprehensive salary and benefits package.