Sr. Scientist, Formulation Development-CMC

Sr. Scientist, Formulation Development-CMC

Exton, PA (Research)

Responsibilities

  • Lead multiple formulation/process/scale up development projects at various stages for solid, or semisolid, or parental dosage forms
  • Perform literature/patent search for innovation product development and generic product development in supporting of regulatory submissions of INDs, NDAs, and ANDAs or patent filings. Apply Quality-by-Design (QbD) principles to product development
  • Review analytical data, draft GMP manufacturing batch records/protocols, and product development reports
  • Lead manufacturing investigations as required
  • Prepare project updates to group and sponsor in a timely manner
  • Provide documents in eCTD format to support regulatory filing. Collaborate with team members (formulators, analytical chemists, quality assurance and manufacturing technicians) to ensureassigned projects to meet agreed timelines

Requirements

  • Ph.D. in Pharmaceutics, Chemistry, Chemical Engineering (or closely related scientific disciplines) with 2-6 years work experience; or MS degree in Pharmaceutics with 5-10 years work experience
  • Hands on experience in Pharmaceutical product development and GMP manufacturing preferably ANDA development and filing experience
  • Familiarity and working knowledge of manufacturing processes and equipment set up, operation and troubleshooting for various pharmaceutical dosage forms
  • Strong written and oral communication skills Good team player r to work with groups CRO experience would be a plus
  • Qualified candidates should forward their resume to HumanResource@frontagelab.com. Please reference the job title in the subject line

Apply Online