The principal scientist is responsible for the following duties:
· Carrying out laboratory work with minimal direction from senior laboratory leaders
· Develop and execute topical drug development strategies leading to regulatory submission
·Mentor junior scientists in semi-solid product development
· Subject matter expert for CMC related activities; including formulation development, process development, container/closure.
·CMC lead to project teams
·Knowledgeable of regulatory requirements for new drug applications in USA and international
·Knowledgeable of eCTD format for regulatory filings
· Familiar with ICH requirements
· Maintain data packs for assigned projects
·Support GLP/GMP manufacturing, including provision of process instructions, batch record review, hands on resource
·Data entry into notebooks or other source documents
·Verification of transcription processes, such as verifying calculations
·Peer review of laboratory notebooks and batch records
· Writing specifications for raw materials and components.
·Project tracking and updates as requested of assigned projects
· Point of contact for external contract research organizations as relevant to Form Dev activities.
· Science degree from an accredited institution with focus in chemistry, biology, pharmaceutics, or similar
· PhD with 3-5 years’ experience, MS with 5-8 years, BS with 8-10+ years
· Experience in semi-solid dosage form development for topical drug delivery
· Experience with dermatology therapeutic area
· Experience with CMC and regulatory filing requirements
· Experience in project management as either project leader or functional lead to project team
·Ability to interact with clients and contractors
· Skilled in drug delivery optimization, using DOE where applicable.