Sr. Scientist/Scientist, Pharmaceutical Drug DevelopmentTitle: Sr. Scientist/Scientist
Location: Exton, PA (CMC)
Full timeResponsibilities:- 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:- PhD in Pharmaceutical Sciences or related fiels with 2-3 years of experience OR MS in Pharmaceutics, Pharmaceutical Science or related field with 7-8 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.
