Responsibilities for this role include:
- Conduct independent literature research to gain new knowledge and understanding required to progress project development.
- Act as the subject matter expert (SME) in the area of chromatography, including HPLC and HR-MS, and other analytical techniques related to characterization of complex molecules.
- Act as point of contact for technical and troubleshooting assistance for the team. Plans and performs analytical method development and validation.
- Provide expertise in defining analytical sameness/equivalence plan for complex products in relation to Innovator products. This also leads to decision making on new APIs screening and selection process for new products.
- Analytical knowledge of peptide products is essential with focus on chromatographic methods, including peak separation and identification by HPLC and HR-MS.
- Lead new projects and drive the timely and successful completion of these projects while harnessing good communication within the team and with other departments within the company.
- Schedule experiments in the lab and provide guidance to individuals in more junior positions.
- Supports formulation and process development studies.
- Assist in transfer of analytical methods to QC or other sites or from other sites into PD.
- Set technical standards to comply with FDA/EMA or regional regulatory requirements.
- Ensure the analytical activities are performed to Viatris EHS standards.
- Experience in LCMS is essential
The minimum qualifications for this role are:
- Minimum of a Bachelor’s degree in a science related discipline (Preferably Chemistry, Biochemistry or Biotechnology) PhD ideally.
- Minimum of 6 years pharmaceutical analytical laboratory experience however relevant academic experience will be considered.
- Previous experience of analytical project lead is desirable. However, a combination of experience and/or education will be taken into consideration.
- Must possess knowledge of analytical operating systems and techniques (especially HPLC and HR-MS). Must have considerable experience of developing wet chemistry, chromatographic or biological methods. Must have analytical knowledge in peptide complex products. Knowledge of FDA/EMA regulations is very desirable.
- Must possess excellent verbal and written communication, organizational skills and computer skills including Excel, Word and Outlook. Be able to work as a flexible analytical lead member of a project team, Quality Orientated, Tight Deadline Awareness, Housekeeping Aware. Strong technical background.