Posted on OINDPnews on May 2, 2018. Job postings may or may not be removed from the site after the position is filled.
Catalent, Morrisville, NC, USA
Position Summary
The role supports Catalent’s Inhalation product development function from product definition up to commercialization. The ideal candidate would have strong technical and regulatory understanding (i.e. NDA, ANDA, 505b2) of inhaled product development (or similar pharmaceutical dosage forms) and would be expected to support inhalation development projects across a potential range of inhaled delivery platforms (MDI, Nasal, DPI, nebulizers, etc.). This individual would have the ability to provide support in developing scope, analyzing, interpreting, and effectively communicating results of drug product development experiments and product characterization studies, while managing these activities to customer timelines. The candidate must have the ability to provide direct oversight to multidisciplinary team of 3 – 5 development scientists.
The Role
- Provide guidance on the development, oversight, and execution of complex technical deliverables for the development of inhaled drug product using both internal and external resources.
- Ability to effectively communicate technical progress to senior internal and external stakeholders both through written and oral communications.
- Work and communicate effectively with other functional groups and across global respiratory R&D sites.
- Liaise with internal and external (contract development, manufacturing, and analytical) departments to achieve project targets.
- Establish and maintain effective and functional team.
- Should possess knowledge of one or number of areas such as analytical methods, formulation, container-closure systems, device design, and manufacturing processes.
- Working knowledge of applicable global regulatory requirements desired
- Knowledge of FDA requirements (essential), understanding of other regulators (MHRA, EMEA, desirable).
The Candidate
- Doctoral degree, Masters degree, or Bachelors degree in chemistry or closely related physical science from a four-year college/university
- PhD and >5 years related experience, MS and >10 years related experience, BS and >14 years related experience, or equivalent education, experience and training
- Experience and prior use of risk analysis tools and their application.
- Experience and prior use of statistical analysis tools, especially experimental design (DoE)
- Prior experience with regulatory submissions (NDA, ANDA, 505b2) a plus
- Experience with CFR 820 combination device regulations
- Strong analytical skill set desired
For more information and to apply, click here.
