Downstream Process Development Leader (Principal Scientist to Director)

Key Responsibilities (Applicable to All Levels)

Project Leadership & Delivery

• Lead downstream process development programs across the full CMC lifecycle, including process development, optimization, characterization, scale-up, and technology transfer.
• Develop purification strategies and project execution plans aligned with program objectives, timelines, quality requirements, and budget considerations.
• Drive key technical decisions related to chromatography, viral clearance, UF/DF, process robustness, and scale-up strategy.
• Identify technical and program risks and develop mitigation plans to ensure successful project delivery.
• Ensure deliverables including study protocols, development reports, technical assessments, and client-facing materials meet high quality standards.

Technical Expertise & Process Development

• Design efficient, robust, and scalable downstream purification processes suitable for clinical and commercial manufacturing.
• Apply statistical and scientific approaches, including Design of Experiments (DoE), process characterization, and data-driven decision-making.
• Address manufacturing challenges related to process yield, purity, aggregates, HCP/DNA clearance, viral safety, and scalability.
• Support process characterization and regulatory readiness activities required for late-stage development and commercialization.

Cross-functional Collaboration & Client Engagement

• Serve as a key technical interface with internal stakeholders including Upstream Development, Analytical Sciences, MSAT, Manufacturing, Quality, and Regulatory Affairs.
• Lead client interactions including technical discussions, project reviews, issue resolution, and milestone communications.
• Facilitate effective cross-functional collaboration to ensure alignment and efficient execution across development and manufacturing activities.

Regulatory & Compliance Support

• Support regulatory submissions including IND, BLA, and other global filings through preparation and review of technical documentation.
• Contribute to regulatory inspections, client audits, and internal compliance activities.
• Ensure development activities comply with applicable GMP and quality requirements.

Responsibilities for Principal Scientist Candidates

Scientific & Project Leadership

• Serve as the end-to-end technical and project leader for downstream development programs.
• Own project scope, timelines, resource forecasts, and critical deliverables while ensuring successful program execution.
• Drive alignment among cross-functional stakeholders and facilitate timely issue escalation and resolution.
• Lead multiple projects simultaneously while maintaining high standards for technical excellence and client satisfaction.

Responsibilities for Director Candidates

Organizational Leadership

• Lead, mentor, and develop a team of downstream scientists and project leaders in a fast-paced environment.
• Build organizational capabilities through talent development, succession planning, coaching, and performance management.
• Foster a culture of scientific excellence, innovation, accountability, and collaboration.

Strategic & Business Leadership

• Provide strategic direction for downstream process development activities across multiple programs and platforms.
• Partner with department leadership to establish departmental objectives, resource planning, and operational priorities.
• Oversee project portfolio execution, resource allocation, budgeting, laboratory utilization, and workforce planning.
• Coordinate priorities across functional groups to meet organizational goals and business objectives.

Technology Innovation

• Identify opportunities to advance downstream technology platforms and enhance organizational competitiveness.
• Lead evaluation, development, validation, and implementation of innovative purification technologies and digital/process improvement initiatives.
• Establish long-term technical strategies that improve platform performance, scalability, and operational efficiency.

Qualifications

For Principal Scientist Candidates

• M.S. with 8+ years or Ph.D. with 5+ years of industry experience in downstream process development for biologics.
• Strong understanding of downstream purification platform technologies including Protein A, ion exchange chromatography, hydrophobic interaction chromatography, mixed-mode chromatography, viral inactivation/filtration, and UF/DF.
• Demonstrated experience in process development, scale-up, process characterization, and technology transfer.
• Experience leading cross-functional project teams and managing client-facing interactions.
• Strong understanding of late-stage development requirements and commercial manufacturing considerations.
• Experience with statistical tools and methodologies, including DoE and data analysis.
• Excellent communication skills in English and Chinese.

For Director Candidates

• M.S. with 10+ years or Ph.D. with 8+ years of progressively responsible experience in biologics downstream process development, with substantial experience supporting late-stage and commercial programs.
• Minimum 4 years of people management experience with demonstrated success in building and leading high-performing teams.
• Strong leadership capability with experience managing project portfolios, resource planning, and organizational priorities.
• Deep understanding of manufacturing constraints and commercial-scale process design.
• Experience with budgeting, workforce planning, and laboratory operations management.
• Significant experience supporting global regulatory filings (IND/BLA) and interactions with health authorities and auditors.
• Demonstrated success driving organizational initiatives, technology platform development, and process innovation.

Preferred Qualifications (All Levels)

• Experience supporting PPQ, commercialization, and post-approval lifecycle management activities.
• Experience supporting client audits, regulatory inspections, and regulatory agency interactions.
• Knowledge of digitalization, process modeling, automation, or advanced data analytics.
• Experience working within a CDMO or complex multi-program environment.
• Proven ability to manage multiple priorities while maintaining delivery excellence.