Associate Scientist, Pharmaceutical Analysis-Microbiology

Frontage; Exton (Chester County); On-site; USD 55,000 - 85,000; Full time

Job summary

Join a dynamic and innovative organization as an Associate Scientist in Pharmaceutical Analysis-Microbiology. In this role, you will engage in routine and non-routine microbiology sample analysis, ensuring compliance with cGMP standards while supporting product development. Collaborating with a team of dedicated professionals, you will contribute to the advancement of drug development through method validation and quality checks. This position offers the opportunity to work in a fast-paced environment where your skills in microbiology and analytical chemistry will be valued and developed. If you are passionate about science and eager to make a difference in the pharmaceutical industry, this is the perfect opportunity for you.

Qualifications

• B.S. in Biology or related discipline with 1-3 years relevant experience.
• Experience in pharmaceutical product testing and BSL2 laboratory is a plus.

Responsibilities

• Perform microbiology sample analysis and method development under supervision.
• Collaborate with team members to meet timelines for drug product delivery.

Skills

Microbiology Sample Analysis

Method Development

Quality Checks

Data Quality

Collaboration

Education

B.S. in Biology

Experience in Pharmaceutical Industry

Tools

cGMP Compliance

BSL2 Laboratory

Job description

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Associate Scientist, Pharmaceutical Analysis-Microbiology

Full Time
Exton, PA, US

Frontage Laboratories:

Frontage Laboratories Inc. (Frontage) is a global contract research organization with broad expertise in supporting pre-clinical and clinical drug development. Frontage operates out of several different locations within the USA, Canada, and China. Frontage’s core competencies include drug metabolism, pharmacokinetics/pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.

Analytical Chemistry-CMC:

We specialize in analytical services and method development, validation and transfer for product development and clinical trial materials (CTM) manufacturing support, as well as commercial product release and stability testing.

Position Summary:

Performs routine and non-routine microbiology sample analysis (specifically, MLT/Bioburden, Endotoxin, Environmental Monitoring, Sterility, and AET) and a variety of tasks to support product development, ensuring agreed timelines.

Responsibilities:

• Performs method development and validation under supervision
• Prepares study protocols, reports, investigation reports, and generates cGMP documents as needed
• Performs quality checks of data, laboratory notebooks, and other scientific documentation as required
• Maintains qualification and compliance of instruments, and conducts technical and equipment troubleshooting as needed
• Reports and resolves any unexpected issues under supervision
• Complies with all relevant cGMP regulatory requirements while carrying out assigned studies
• Collaborates with team members (Analytical Scientists, Quality Assurance, Material Coordinators, and Manufacturing Technicians) to meet timelines for drug product delivery
• Identifies opportunities for improvement in quality of services, and works with the team to implement

Requirements:

• B.S. in Biology or related discipline with 1-3 years relevant experience in pharmaceutical or related industry (CRO experience is a plus)
• Experience in pharmaceutical product and facility testing (MLT/Bioburden, Sterility, Endotoxin, Environmental Monitoring, AET)
• Experience working in a BSL2 laboratory is a plus
• Capable of setting priorities based in a fast-paced, changing environment
• Excellent oral and written communication skills, attention to detail and data quality, and experience working on diverse collaborative teams.

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.