What are the responsibilities and job description for the Microbiologist (Rochester, MN) position at CEDENT?
The Microbiologist will play a key role in the execution of microbiological Quality Control (QC) methods and support Client drug development.
Description
PRINCIPAL RESPONSIBILITIES:
Bachelor's degree in biology or related area required, advanced degree preferred.
Minimum of 3 years of related experience required within cGMP Microbiology laboratory.
Minimum of 3 years of related experience required sterile pharmaceutical compounding.
Working knowledge of 21 CFR 210, 211, 212 required.
Working knowledge of USP and/or highly preferred.
Writing of Microbiological QC SOPs, test methods, protocols, and reports, required.
Experience with aseptic techniques while performing Sterility, Endotoxin, and Bioburden testing of drug products, intermediates, and raw materials per USP and Standard Operating Procedures required. Testing of radioactive drug products, preferred.
Radioactive material handling of gamma, beta and/or alpha emitters in radiological facilities (shielded glove boxes, hot cells etc.) preferred.
Work in facilities compliant with ICH Q7, GxPs, 21 CFR 211 and/or 21 CFR 212 required. Knowledge of regulations applicable to drugs and (21 CFR Parts 210/211, ICH, and FDA guidance, etc.) and the ability to apply them based on the phase of the project (GLP, Phase I, Phase II/III, etc.) required.
Advanced ability to effectively lead one or more projects with competing priorities to meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities.
Extended hours, night shift and weekend work may be required occasionally.
In-depth critical thinking skills to evaluate issues and identify a potential solution. Creatively addresses complex or new problems.
Advanced interpersonal skills, including but not limited to problem-solving, teamwork development, and leadership with other team members. Works well with others to achieve common goals.
Ability to foster an inclusive and cooperative work environment.
Ability to work sitting and standing for extended periods, grasping/gripping, fine motor control with hands.
Ability to lift / move, transport, position equipment and work items weighing up to 30 pounds across on a frequent basis.
Ability to work in a cleanroom and sterile compounding environment, adhering to strict health and hygiene standards to ensure the safety and quality of drug products.
Must report any health conditions (e.g., rashes, active infections) that could impact product integrity or contamination risks.
Chronic health conditions that prevent long-term performance of essential job functions may require evaluation and could affect employment status.
Description
PRINCIPAL RESPONSIBILITIES:
- Develops and executes microbiological methods for radioactive drug products in a GxP environment, including Sterility and Bioburden testing of radioactive drug products, intermediates, and raw materials per USP and Standard Operating Procedures (SOP).
- Review and interpret domestic (FDA) and international regulations (if applicable) standards and guidelines covering cleanroom management, aseptic techniques, sterilization, and microbial contamination control in the manufacture of aseptic Clientceutical products.
- Perform Growth Promotion testing per USP Methods for various microbiological media.
- Prepare and analyze Biological Indicators in support of Validation and Qualification activities.
- Perform environmental monitoring (EM) activities.
- Analyze microbial samples to quantify growth and subculture pure isolates as required. Provide support and assistance with environmental monitoring activities.
- Provides support and assistance for laboratory personnel in daily activities to fulfill client and GMP requirements.
- Responsible for training Microbiology Techs on cGMP guidelines 21 CFR 210, 211, 212 (as applicable) and microbiological test methods.
- Responsible for training QC Techs in microbiological testing methods.
- Serves as a Subject Matter Expert for microbiological testing on site. This may involve participation in customer audits and regulatory inspections.
- Collaborate with other groups within the facility to understand goals and communicate changes throughout the organization.
- Writes necessary SOPs, Validation Protocols and Validation Report.
- General laboratory housekeeping duties and maintenance of the department, premises, and equipment.
- Coordinate inventory of laboratory supplies.
- Collaborate with other team members to ensure the consistent and timely completion of all testing and other tasks in support of business needs.
- Ensure a safe and quality-minded working environment through conformance with training, general awareness, compliance to safety/Quality guidelines and SOPs, and radiation protection guidelines.
- Attend mandatory trainings as required by site regulatory requirements and management.
- Perform other general duties associated with the position as required by supervision.
- Performs other duties as assigned.
Bachelor's degree in biology or related area required, advanced degree preferred.
Minimum of 3 years of related experience required within cGMP Microbiology laboratory.
Minimum of 3 years of related experience required sterile pharmaceutical compounding.
Working knowledge of 21 CFR 210, 211, 212 required.
Working knowledge of USP and/or highly preferred.
Writing of Microbiological QC SOPs, test methods, protocols, and reports, required.
Experience with aseptic techniques while performing Sterility, Endotoxin, and Bioburden testing of drug products, intermediates, and raw materials per USP and Standard Operating Procedures required. Testing of radioactive drug products, preferred.
Radioactive material handling of gamma, beta and/or alpha emitters in radiological facilities (shielded glove boxes, hot cells etc.) preferred.
Work in facilities compliant with ICH Q7, GxPs, 21 CFR 211 and/or 21 CFR 212 required. Knowledge of regulations applicable to drugs and (21 CFR Parts 210/211, ICH, and FDA guidance, etc.) and the ability to apply them based on the phase of the project (GLP, Phase I, Phase II/III, etc.) required.
Advanced ability to effectively lead one or more projects with competing priorities to meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities.
Extended hours, night shift and weekend work may be required occasionally.
In-depth critical thinking skills to evaluate issues and identify a potential solution. Creatively addresses complex or new problems.
Advanced interpersonal skills, including but not limited to problem-solving, teamwork development, and leadership with other team members. Works well with others to achieve common goals.
Ability to foster an inclusive and cooperative work environment.
Ability to work sitting and standing for extended periods, grasping/gripping, fine motor control with hands.
Ability to lift / move, transport, position equipment and work items weighing up to 30 pounds across on a frequent basis.
Ability to work in a cleanroom and sterile compounding environment, adhering to strict health and hygiene standards to ensure the safety and quality of drug products.
Must report any health conditions (e.g., rashes, active infections) that could impact product integrity or contamination risks.
Chronic health conditions that prevent long-term performance of essential job functions may require evaluation and could affect employment status.
