Location: Exton,PA, USA
Scientist I, Pharmaceutical Drug Development
Title: Scientist I
Location: Exton, PA (CMC)
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.
Responsibilities:
* Perform necessary literature and patent search to support studies for development of drug products and generate data/development reports for use by the sponsors as part of their regulatory submissions or patent filings.
* Plan and perform various stages of product development studies, including pre-formulation, formulation development, process development, optimization, and technology transfer.
* Incorporate Quality-by-Design tools in drug development. Develop prototype formula and evaluate the predetermined QTPPs and CQAs.
* Write and review GMP documentation, including manufacturing batch records, and appropriate study protocols, and interface with CTM Manufacturing Team for technology transfer for CTM Batch Manufacturing.
* Collaborate with team members (Analytical Scientists, Quality Assurance, Material Coordinator, and Manufacturing Technicians) to meet timelines for drug product delivery.
* Assist department supervisor in collaborating with sponsor(s) to facilitate transfer of knowledge and deliverables of drug product.
* Follow company policies and conduct work according to appropriate Frontage SOPs and comply with cGMP guidelines.
Requirements:
* MS in Pharmaceutics, Pharmaceutical Science or related field with 1-3 years of experience.
* In depth knowledge of theory and techniques in drug development and drug delivery.
* Experience in sterile product development including emulsions, suspensions, and lipid-based delivery systems. cGMP knowledge and hands-on experience in sterile small molecule and Protein/biologics product development is a plus.
* Strong written, and verbal communication, and presentation skills.
* Good understanding cGMP, Regulatory Compliance including FDA/EU/ICH guidance with regards to drug development.
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.