Principle Scientist, Product Development

Key Skills

Apache Hadoop, C Programming, C++, Data science techniques, Java Programming, Machine learning techniques, MapReduce, Python Programming, PyTorch, R Programming, Scala Programming, SQL, TensorFlow

Job Description

Requirements:

Academic Requirements: Bachelor’s degree in Chemistry, Chemical Engineering or Pharmaceutical Sciences with a minimum of 12 years relevant professional experience. Individuals with advanced degrees in the same field of study with commensurate experience will also be considered.

Professional Experience: The individual must possess deep pharmaceutical formulation and process development familiarity and experience across multiple product types; direct experience with injectable products is preferred. The individual must have advanced laboratory skills, including experience with modern chromatographic (HPLC, GC, IC, TLC, etc.) and wet chemistry (USP) techniques; experience using ICP-MS equipment is also desired; direct analytical method development and validation experience is required. All product development scientists must possess excellent data management skills, good laboratory practices, as well as experience with data mining and analytics, including the ability to perform scientific calculations, statistical analysis, and data processing using MS Excel or equivalent software. All product development scientists must also possess excellent writing and scientific communication skills, including direct experience creating GMP documentation suitable to support quality and regulatory compliance needs. Excellent learning and teaching skills are also required to advance individual abilities and the institutional knowledge of peers and junior staff members, respectively. Familiarity and experience with handling radiopharmaceutical products are required.

Other Requirements: This position requires hands on bench work in a laboratory setting. The individual must be willing to work on projects with high visibility and short timelines as well as be flexible with frequent changes in project priority. The individual must have a demonstrated ability to advance novel programs from concept into scientifically sound working systems that are properly supported by objective analytical data.

Responsibilities/Accountabilities:

The Product Development organization is responsible for developing and commercializing internal (NPHS) and external (sponsor) drug products under a services model. For the current role, the incumbent will provide hands-on laboratory work and technical expertise across analytical, formulation, and process development activities for new sponsor products. The individual will design development studies, write and execute protocols in collaboration with operations personnel, collect and analyze scientific data, and prepare study reports. The individual will create, troubleshoot, resolve, and implement process improvements, identify and develop scientific solutions using sound statistical experimental designs and multivariate analysis, and apply the principles of physical/organic chemistry and materials science for product development.

The individual will need to effectively communicate with personnel in other departments, present technical data at team and department meetings, and provide key timeline information to project management. Representing analytical, formulation, and process functions on cross functional project teams, the individual will coordinate development activities at local manufacturing sites with different stakeholders. The individual will play a critical role in large scale product and process development programs.