Principal Scientist​/Director – Biologics Drug Substance Commercialization

• Lead downstream and/or integrated drug substance teams for late-stage clinical and commercial programs
• Provide technical leadership for laboratory-scale and manufacturing-scale studies involving process characterization, validation, investigations, and continued process verification
• Serve as a downstream subject matter expert across core unit operations and upstream, analytical, and GMP manufacturing interdependencies
• Ensure process and product knowledge are developed, documented, and transferred according to company standards and regulatory expectations
• Support technology transfer to internal and external manufacturing sites, including scale-up, process validation, and manufacturing readiness
• Contribute to manufacturing investigations and lifecycle management for commercial processes
• Author and review technical and regulatory documentation, including regulatory submission sections
• Drive division-wide biologics manufacturing and commercialization initiatives
• Influence multi-year planning for capability needs, digital systems, and platform evolution
• Represent BDSC on cross-functional and cross-divisional teams
• Collaborate with internal stakeholders and external partners, including contract development and manufacturing organizations
• Lead, coach, and mentor downstream scientists
• Promote innovation, continuous improvement, and operational excellence in the laboratory
• Support resource planning, staffing strategies, hiring decisions, and talent development

• BS, MS, or PhD in Chemical Engineering, Biological Engineering, Chemistry, or a related discipline
• Fourteen (14) years of industry experience with a BS, twelve (12) years with an MS, or six (6) years with a PhD
• Deep technical expertise in downstream processing of biologics
• Ability to independently design, direct, execute, analyze, and document all stages of process development
• Experience supporting biologics commercialization, including late-stage development and/or commercial manufacturing
• Ability to prioritize and deliver complex objectives in fast-paced, dynamic environments
• Strong leadership and collaboration skills within cross-functional, matrixed organizations
• Action-oriented problem-solving mindset with a track record of innovation and continuous improvement
• Commitment to coaching and mentoring scientific staff
• Excellent written and verbal communication skills
• Preferred: leadership experience on drug substance working groups or program teams
• Preferred: direct people management experience
• Preferred: hands-on experience with technology transfer, scale-up, and validation of biologics processes
• Preferred: in-depth knowledge of preparative chromatography, tangential flow filtration, and virus retentive filtration
• Preferred: experience developing or supporting multi-specific antibody therapeutics
• Preferred: experience with process characterization, viral clearance studies, PPQ, and validation
• Preferred: experience authoring regulatory submission content and/or working with external development or manufacturing partners
• Preferred: working knowledge of analytical characterization of biologics, cGMPs, and U.S./EU regulatory expectations
• Preferred: experience applying lean leadership and operational excellence principles
• Willingness to travel 10%

Demonstrates deep technical expertise in downstream processing of biologics, with a strong focus on process development, technology transfer, and regulatory compliance. Proven leadership in managing cross-functional teams and driving innovation in biologics manufacturing and commercialization.

• Downstream Processing of Biologics
• Process Development and Validation
• Regulatory Submission Authoring
• Leadership in Cross-Functional Teams
• Technology Transfer and Scale-Up

• Process Characterization
• Viral Clearance Studies
• Preparative Chromatography
• Tangential Flow Filtration
• Virus Retentive Filtration
• Multi-Specific Antibody Therapeutics
• PPQ
• CGMP Compliance
• Analytical Characterization of Biologics
• Lean Leadership Principles

• Strong Leadership Skills
• Collaboration Skills
• Action-Oriented Problem Solving
• Coaching and Mentoring
• Excellent Communication Skills

• Biologics Manufacturing
• Commercialization
• GMP Manufacturing
• Regulatory Expectations
• Process Verification
• Lifecycle Management
• Innovation
• Operational Excellence
• Cross-Functional Collaboration
• Talent Development