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
Develop and characterize liquid formulations for biologics, with particular emphasis on enzyme drug product formulation or co-formulations
Build process understanding across unit operations to support scalable drug product development
Apply machine learning, AI, and data science to predictive modeling, workflow acceleration, and decision-making
Author/review guideline documents, technical protocols and reports, risk assessments, and regulatory sections in support of IND and marketing application submissions
Provide support to clinical and commercial technology transfer activities and manufacturing operations through process fit assessments, process capability analysis, troubleshooting, root cause analysis, and product impact assessments for process changes/improvements and non-conformance investigations
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 drug product platforms and contribute to process design improvement projects
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.
Basic Qualifications
Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]
OR
Master’s degree and 3 years of Scientific experience
OR
Bachelor’s degree and 5 years of Scientific experience
Preferred Qualifications
PhD in Pharmaceutics, Biotechnology, Chemical Engineering, Bioengineering, Biochemistry, or related field with 2–4 years of postdoc or industry experience
