Associate Scientist, Pharmaceutical Analysis-Microbiology

ZipRecruiter; Exton (Chester County); On-site; USD 55,000 - 75,000; Full time

Job summary

A leading contract research organization is seeking an Associate Scientist in Pharmaceutical Analysis-Microbiology. The role involves performing microbiology sample analyses, developing methods, and ensuring compliance with regulatory requirements. Ideal candidates will have a B.S. in Biology and relevant experience in the pharmaceutical industry.

Qualifications

• 1-3 years of relevant experience in pharmaceutical or CRO industry.
• Experience in pharmaceutical testing: MLT/Bioburden, Sterility, Endotoxin.

Responsibilities

• Develops and validates methods under supervision.
• Prepares study protocols and cGMP documentation.
• Ensures compliance with cGMP regulatory requirements.

Skills

Communication

Attention to Detail

Collaboration

Education

B.S. in Biology

Job description

Job Description Associate Scientist, Pharmaceutical Analysis-Microbiology

Full-time

Location: Exton, PA

About Frontage Laboratories:

Frontage Laboratories Inc. (Frontage) is a global contract research organization supporting pre-clinical and clinical drug development. With locations across the USA, Canada, and China, our core services include drug metabolism, PK/PD, safety and toxicology, bioanalytical services, chemistry and manufacturing controls, and core laboratory services for clinical trials.

Analytical Chemistry-CMC:

We specialize in analytical services, method development, validation, transfer for product development, clinical trial materials support, and commercial product release and stability testing.

Position Summary:

Performs routine and non-routine microbiology sample analyses (e.g., MLT/Bioburden, Endotoxin, Environmental Monitoring, Sterility, AET) and supports product development to meet project timelines.

Responsibilities:

1. Develops and validates methods under supervision.
2. Prepares study protocols, reports, investigation reports, and cGMP documentation.
3. Performs quality checks of data, notebooks, and scientific documentation.
4. Maintains instrument qualification and compliance; troubleshoots technical issues.
5. Reports and resolves unexpected issues under supervision.
6. Ensures compliance with all relevant cGMP regulatory requirements.
7. Collaborates with team members to meet drug product delivery timelines.
8. Identifies and implements opportunities for quality improvement.

Requirements:

1. B.S. in Biology or related field with 1-3 years of relevant experience in pharmaceutical or CRO industry.
2. Experience in pharmaceutical testing: MLT/Bioburden, Sterility, Endotoxin, Environmental Monitoring, AET.
3. Experience working in a BSL2 laboratory is a plus.
4. Ability to prioritize in a fast-paced, changing environment.
5. Strong communication skills, attention to detail, and ability to work collaboratively.

Equal Opportunity Statement:

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or other protected status.