Process Development Senior Scientist

What you will do

• 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

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
• Experience integrating formulation, stability, and analytical data to advance biologics including enzyme, mAb and peptide candidates is highly desirable
• Demonstrated understanding of biologics drug product development considerations, including protein stability, degradation pathways, quality attributes, and product/process comparability
• Experience developing or characterizing enzymes, including assessment of activity, stability, and performance under relevant formulation or process conditions
• Experience in formulation and co-formulation development, fill-finish process engineering, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments
• Strong foundation in analytical and biophysical techniques relevant to biologics (e.g., UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, subvisible particle analysis, etc.)
• Experience with programming, application of AI-enabled tools as well as data visualization tools (e.g. Tableau, Spotfire)
• Skilled communicator with experience contributing to regulatory submissions (CTAs, BLAs)
• Strong project management skills, including the ability to manage one's project resources (material, workforce, time, etc.)
• Critical thinking, problem solving and independent research skills
• Strong ability to operate well in a fast-paced, matrixed environment and collaborate successfully cross-functionally