Scientist - Exton, PA, US
18 hours ago
Job description
Scientist/Sr. Scientist
Division/Department: Analytical Services, CMC (Chemistry, Manufacturing, and Controls)
Reports to: Manager/Group Leader
Full-time
Location: Exton, PA
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.
Job Summary
The Scientist or Sr. Scientist is responsible for supporting in vitro release Testing /In vivo Release testing on drug products. The scientist's duties include analytical method development/method validation, protocol/report writing, IVRT/IVPT apparatus maintenance and qualification.
Role & responsibilities
1. Hands-on experience in conducting, planning and monitoring In-vitro skin permeation studies and Invitro Release Testing: IVPT/IVRT development, validation, pilot study and pivotal study.
2. Thorough knowledge and complete understanding on FDAs requirement for IVPT studies.
3. Data interpretation and day-to-day troubleshooting related to IVPT studies.
4. Should have experience in review of raw data and protocol/report preparation for development, validation, pilot and pivotal studies.
5. Adhere to compliance and regulatory requirement for in-vitro studies.
6. Implementation and revision of SOP's related to IVRT and IVPT studies.
7. Good Subject knowledge related to Bio-analytical methods/Bio samples analysis and interpretation of bioanalytical data.
8. To ensure routine calibration and preventive maintenances of IVRT and IVPT lab instruments within timelines.
9. Should have experience in writing justification and design of experiments to address Agency's deficiencies on IVRT and IVPT.
10. Review and preparation of all study protocols and reports.
11. Interaction with cross functional team and to meet the project timelines.
12. Comfortable handling and/or working with biological tissues such as human skin .
13. Follow company policies and conduct work according to appropriate Frontage SOPs and comply with GLP/cGMP guidelines.
Essential Duties & Responsibilities
Method development/Validation on IVRT/IVPT testing.
Any other drug product testing work.
Protocol/Report writing, Data Review.
Educational/Training Requirement: bachelor's degree or above
Experience: at least two years of related work experience
Knowledge, Skills, and Abilities (KSAs): Clear communication, organization, and teamwork.
Travel Requirements: 0%
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.
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