Director Process Development

Role Summary

Director Process Development. Drive cross-functional teams in the development of biosimilar products from pre-clinical through commercial stages, leading analytical and nonclinical similarity assessments to support regulatory approval and commercial success. Provide scientific, business, and tactical leadership across internal and external stakeholders.

Responsibilities

• Lead the development and execution of analytical and nonclinical similarity assessment strategies, including biological, biochemical, and biophysical characterization, in accordance with current regulatory guidance.
• Oversee cross-functional collaboration with Research Therapeutic Discovery, Translational & Safety Pharmacology, Clinical Development, Process Development, Quality, Manufacturing, Regulatory, Legal, and Commercial teams.
• Guide process development to achieve similarity, leveraging expertise in structure-function relationships and risk ranking of quality attributes.
• Provide scientific leadership in characterizing biochemical, biophysical, and functional properties of antibodies and recombinant proteins.
• Design and implement in vitro pharmacology study plans to demonstrate nonclinical similarity.
• Advise on statistical analysis and graphical presentation approaches for regulatory submissions, including briefing documents and dossiers.
• Author and review analytical similarity sections for regulatory submissions throughout the product lifecycle (briefing books, INDs, amendments, marketing applications).
• Lead responses to scientific questions from global regulatory agencies.
• Collaborate with internal and external partners, including contract labs, to support analytical development.
• Contribute to biosimilar publication plans and external scientific communications (oral presentations, posters, articles).

Qualifications

• Basic Qualifications: Doctorate degree and 4 years of pharmaceutical experience OR Master’s degree and 8 years of pharmaceutical experience OR Bachelor’s degree and 10 years of pharmaceutical experience. In addition, at least 4 years’ experience directly managing people and/or leadership experience leading teams, projects, programs, or directing resource allocation.
• Preferred Qualifications: Advanced degree (Ph.D., Pharm.D., or equivalent) in Chemistry, Biochemistry, Biology, or related field; extensive experience in process development within pharma/biotech with a focus on biosimilars; expertise in analytical sciences, structure-function characterization, nonclinical pharmacology, regulatory submissions, and cross-functional leadership; strong knowledge of FDA, EMA, and global biosimilar regulatory requirements; excellent communication, collaboration, and project management skills; proven ability to mentor and lead scientific teams.

Skills

• Analytical sciences
• Structure-function characterization
• Nonclinical pharmacology
• Regulatory submissions
• Cross-functional leadership
• Communication and project management

Education

• Doctorate degree or Master’s/Bachelor’s with equivalent pharmaceutical experience (as defined above)