The candidate is responsible for creating and qualifying/validating analytical methods and providing technical guidance for development projects and commercial product creation. This role is responsible for starting, leading and delivering scientific research, while keeping a broad knowledge of analytical techniques.
- Create and overlook (qualify/validate) new methods analytical techniques (e.g., HPLC, GC, LC-MS)
- Give technical and analytical guidance to support new drug product creation and manufacture of new products.
- Create, execute and interpret experimental study results.
- Summarize findings for internal presentation (e.g. slide presentations, reports).
- Review findings in lectures, technical reports, and documents for external distribution and/or presentation.
- Write and/or review documents for regulatory submissions (e.g. INDs, NDAs, SOPs, analytical methods, qualification and validation documentation) .
- Maintain high level of technical knowledge in areas of accountability.
- Provide strong working knowledge of the use, maintenance and repair of research laboratory equipment
- Tutor or supervise less experienced team members, where proper.
- Apply the expertise, skills and experience obtained to increase efficiency in solving new difficulties.
- Comply with cGMPs where suitable.
- Preserve cooperative working relationships with other areas (e.g. Formulation Development, Process Development QC, QA, Regulatory).
- Preserve good documentation and exercise clear, concise interaction skills.
Qualifications:
- PhD in relevant field of study (e.g. Analytical Chemistry, Physical Chemistry, Pharmacy, etc.) plus at least 3 years of experience in the pharmaceutical industry, or MS with at least 8 years of experience.
- Broad knowledge of analytical techniques utilized in the pharmaceutical industry with a strong emphasis on HPLC method development and qualification/validation.
