Overview In this role you will support drug product development within Frontage's CMC-focused operations. You will contribute to pre-formulation, formulation development, process development, and technology transfer, applying Quality-by-Design tools. You will collaborate with analytical, QA, and manufacturing teams to meet sponsor timelines and regulatory expectations. The position offers impact across development stages and potential involvement in submissions and filings. This is an opportunity to advance drug product delivery within a globally operating, award-winning CRO.
Compensation / Benefits- health and dental insurance
- 401(k) plan
- disability insurance
- life insurance
Responsibilities- Perform literature and patent searches to support development studies and generate data for regulatory submissions or patent filings
- Plan and execute stages of product development (pre-formulation, formulation, process development, optimization, tech transfer)
- Incorporate Quality-by-Design tools and define QTPPs and CQAs
- Write and review GMP documentation and batch records; interface with CTM Manufacturing Team for technology transfer
- Collaborate with Analytical, QA, Material Coordination, and Manufacturing teams to meet timelines
- Assist supervisor in sponsor communications to transfer knowledge and deliverables
- Follow SOPs and comply with cGMP guidelines
Key requirements- PhD in Pharmaceutical Sciences or related field with 2-3 years of experience or MS in Pharmaceutics, Pharmaceutical Science or related field with 7-8 years of experience
- Deep knowledge of drug development and delivery theories and techniques
- Experience in sterile product development (emulsions, suspensions, lipid-based systems)
- cGMP knowledge and experience in sterile small molecule and protein/biologics development is a plus
- Strong written, verbal, and presentation skills
- Understanding of cGMP and regulatory guidance (FDA/EU/ICH) relevant to drug development
- Strong communication
- Team collaboration
- Attention to detail
- Sterile product development
- QbD tools
- Technology transfer
