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Scientist, Pharmaceutical Analysis-Microbiology - Exton, United States - Frontage Laboratories
Description
Scientist, Analytical Services-CMC MicrobiologyFull-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 (Bioburden, Endotoxin, Environmental Monitoring, Sterility, etc.) 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 Coordinator, and Manufacturing Technicians) to meet timelines for drug product delivery.
Requirements:
B.S. in Biology or related discipline with 3-5 years relevant experience in pharmaceutical or related industry (CRO experience is a plus)
Experience in pharmaceutical product and facility testing (Bioburden, Sterility, Endotoxin, Environmental Monitoring)
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.
