Please note: This position is based in Wuxi, Jiangsu Province, China.
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.