Sr Scientist

Responsibilities

• Participate in Drug Product Commercialization Teams responsible for conducting process development of pipeline products and for supporting commercial products through lifecycle management
• Design, plan, complete, and document formulation and process development studies
• Apply scientific/engineering principles and techniques to develop, characterize and implement processes and next generation technologies and to solve technical challenges
• Apply advanced statistical/data analytics techniques to draw conclusions and inform decisions
• Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for process changes/improvements and non-conformance investigations
• Author/review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions
• Stay current on the latest developments in the industry and scientific community to continue innovating and to meet future business needs
• Effectively and consistently communicate with management, cross-functional partners and relevant team members on progress towards achievements and forthcoming program needs
• Lead cross functional initiatives enhancing Pivotal Drug Product platforms
• Manage and contribute to process design improvement projects

Qualifications

• Doctorate degree PhD OR PharmD OR MD OR Masters degree and 3 years of Scientific experience OR Bachelors degree and 5 years of Scientific experience