Scientist/Senior Scientist, Pharmaceutical Analysis in Exton

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Job DescriptionJob DescriptionScientist/Senior Scientist - Pharmaceutical Analysis - Large Molecule

Location: Exton, PA

Full-time

Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our 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.

Roles and Responsibilities:

• Develop and apply biochemistry, biophysics methods, immunoassays, and other state of the art analytical technologies to analyze and characterize oligonucleotides, cell and gene products, biotherapeutic proteins, their conjugates, and variants.
• Perform method development, validation, tech transfer, product characterization, impurity profiling, routine and stability testing across varieties of biologics products.
• Prepare project proposals, protocols, reports, Certificate of Analysis, investigation reports, and generate cGMP documents.
• Prepare and review notebooks in compliance with Frontage CMC SOPs.
• Maintain qualification and compliance of instruments, and conduct technical and instrumental troubleshooting.
• Manage projects from initiation to completion and ensure the projects are on time, on budgets, and meeting pre-established quality standards.
• Under guidance of supervisor, contribute and/or lead the creation of new service portfolios for emerging biotherapeutics.

Skills/Knowledge Required:

• PhD in Biological Science, Biochemical Engineering, or related discipline with 0-2+ year’s relevant industrial analytical development experience, or MS with 0-4+ year’s analytical development experience for biologics.
• It is a plus to have experience in applying biochemistry (e.g., icIEF, CE-SDS, HPLC, LC-MS, ELISA, etc.) and biophysics (CD, DSC, DLS, etc.) analytical method for characterization and release of biologics such as recombinant proteins and monoclonal antibodies.
• Excellent oral and writing communication, and organization skills.
• Demonstrated enthusiasm to learn and collaborate.

Salary and Benefits:

Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, insurance, and life insurance.

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to , , , , , , , , status as a protected veteran, among other things, or status as a qualified individual with .

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