Assoc Prin. Scientist, Engineering

Job Description

We are currently seeking an Associate Principal Scientist/Engineer for our Pharmaceutical Commercialization Technology (PCT) team. PCT is responsible for pharmaceutical process development of primarily oral solid dosage forms from Phase IIb through regulatory filings, process performance qualification, and into commercial supply. Our work is supported by development facilities in West Point, PA, and Rahway, NJ, a primary commercialization site in Ireland, and a global network of internal and external supply sites.

The Associate Principal Scientist will serve as a key technical and business leader, overseeing process development activities for a segment of the late-stage pharmaceutical project portfolio. This role leads teams responsible for creating and executing process development plans, aligning with clinical supply plans, developing, and documenting the knowledge base needed for regulatory filings, and managing the project through early launch and supply steps. The Associate Principal Scientist also ensures that interfaces with relevant partner groups - upstream, downstream, and parallel are managed collaboratively, efficiently, and effectively.

The successful candidate may lead high-impact, complex, cross-functional teams and initiatives. The Associate Principal Scientist will champion cultural change to support and realize PCT’s and our Company's vision, driving technical excellence and understanding. The Associate Principal Scientist should have fluency in risk-based approaches to development, design of experiments, and process modeling. Proficiency in scientific writing is essential for preparing technical reports and authoring CTD sections to support product registration efforts. 

Primary activities include, but are not limited to:

Advance the pipeline:

• Decides on development plans and outcomes for Final Market Formulations and commercial processes
• As project team leader, develops high-performing teams, or as a key member of multiple smaller teams influences direction for optimal solutions based on use of systematic planning, risk, and options analysis tools. Escalates issues appropriately for visibility and resolution

Technical expertise and technology development:

• Acts as Subject Matter Expert (SME) in technical areas to efficiently solve problems using appropriate tools and prior knowledge. 
• Has fluency of scientific/technical concepts and techniques, applies and furthers those concepts and techniques in pursuit of resolving scientific/technical issues. 
• Supports technical capability build and knowledge sharing within organization
• Technical depth and breadth in all aspects of solid dosage form and process development, including standard and enabled formulations and processes, characterization techniques, experimental data analysis and modeling, including statistical and first principal approaches.
• Leads application of process development in accordance with ICH principles in regulatory filings, with an emphasis on process robustness and flexibility …