Associate Scientist, Pharmaceutical Analysis-Microbiology

Job Description

Associate Scientist, Pharmaceutical Analysis-Microbiology

Full-time

Exton, PA

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, pharmokinetics/ 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.

Full-time