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.
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
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.
Skills Required
- B.S. in Biology or related discipline
- 1-3 years relevant experience in pharmaceutical or related industry
- Experience in pharmaceutical product and facility testing (MLT/Bioburden, Sterility, Endotoxin, Environmental Monitoring, AET)
- Knowledge of and compliance with cGMP regulatory requirements
- Capable of setting priorities in a fast-paced, changing environment
- Excellent oral and written communication skills, attention to detail and data quality, and experience working on collaborative teams
- CRO experience
- Experience working in a BSL2 laboratory
What We Do
Frontage Laboratories, Inc. is a CRO that provides integrated, science-driven, product development services throughout the drug discovery and development process to enable pharmaceutical and biotechnology companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of molecules through development and file regulatory submissions in the United States, China and other countries.
