Process Development Senior Scientist - Pivotal Drug Product Technologies

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 ORMasters degree and 3 years of scientific experience ORBachelors degree and 5 years of scientific experience
• Advanced Degree in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Chemistry, Materials Science, Pharmaceutics or related field
• Experience in pharmaceutical/biotechnology development and manufacturing
• Experience in biologics process development, formulation development, fill-finish process engineering, technical transfers to global manufacturing sites, and statistical design and analysis of experiments
• Experience with development and characterization of formulations and drug product manufacturing processes
• Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down model development, characterization, and scale-up
• Understanding of physical/chemical stability of proteins and how process related stress impacts product quality
• Proficiency in at least one statistical software package (e.g. SAS, JMP or Minitab)
• Critical thinking, problem solving and independent research skills
• Strong project management skills, including the ability to manage ones project resources (material, workforce, time, etc.)
• Good organizational skills with strong attention to detail
• Strong ability to operate well in a fast-paced, matrixed environment and collaborate successfully cross-functionally