Scientist, Sterile Product Development-CMC

Scientist, Sterile Product Development-CMC

Exton, PA (Research)

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, perform and lead various stages of product development, including pre-formulation, formulation development, process development, optimization, scale-up studies/technology transfer
  • Incorporate Quality-by-Design tools in drug development. Develop prototype formula and evaluate the predetermined QTPPs and CQAs, and continue to improve the formula to reach the development goal
  • Write and review GMP documentation, including manufacturing batch records, and appropriate study protocols, and lead project-specific clinical manufacturing
  • Collaborate with team members (Analytical Scientists, Quality Assurance, Material Coordinator, and Manufacturing Technicians) to meet timelines for drug product delivery and assist in working out investigation plans related to manufacturing investigations as required
  • Interact and collaborate with sponsor 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 Pharmaceutics, Chemistry, Polymer Chemistry or Chemical Engineering, with 2-6 years of experience, or Master’s with equivalent experience
  • In depth knowledge of theory and techniques in pharmaceutics and drug delivery
  • Solid knowledge in sterile product development and manufacturing per cGMP compliant procedures, as well as for IND and ANDA
  • Hands on experience in sterile product development including emulsion, suspension, and lipid-based delivery systems. Protein/biologics experience is a plus
  • Strong written and verbal communication and presentation skills
  • Good understanding of regulatory stability requirements, including FDA/ICH guidance in regards to sterile drug development

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