Downstream Process Development (DSPD) Function Lead

WuXi Biologics; United States; On-site; USD 140,000 - 200,000; Full time

Job summary

WuXi Biologics in the United States seeks an experienced project leader to own downstream DSPD projects end-to-end, delivering milestones on time and within quality standards.

You will drive cross-functional collaboration across analytical, upstream, and manufacturing teams, manage risks, and prepare client communications and technical reports.

This role requires strong DoE, data analysis, and project coordination skills, with experience in GMP environments.

Qualifications

• Experience with commercial or late-stage projects (PPQ, GMP tech transfer, IND/BLA docs).
• Experience supporting client audits or regulatory inspections.
• Modeling/statistical/digital capabilities (e.g., DoE, data analysis automation).
• Team management or project coordination across multiple deliveries.

Responsibilities

• Full lifecycle management of downstream DSPD projects: define scope, milestones, and plans.
• Develop downstream purification strategies and scale-up plans.
• Lead cross-functional collaboration and client communications to ensure milestones and risk management.

Skills

DoE

Data analysis

Team management

Cross-functional collaboration

Client communication

Job description

Please note: the positions (multiple levels) are based in Wuxi, Jiangsu Province, China.

Role Objective

End-to-end accountability for downstream DSPD projects, ensuring the delivery of client/internal milestones within defined cost, timeline, and quality standards. As the project lead, efficiently drive cross-functional collaboration, identify and manage risks, and facilitate critical decision-making.

1. Project Delivery & Planning Management

• Responsible for full lifecycle management of downstream projects from initiation to delivery: define project scope, key deliverables, critical path, and milestones; establish and continuously update project plans (including resource/FTE requirements).
• Accountable for key project deliverables, including but not limited to: experimental protocol design, data integrity and quality, development reports, process strategy outputs, and client communication materials.
• Continuously identify risks and deviations during project execution; proactively drive issue resolution and escalation to ensure on-time project delivery.

2. Technical Strategy & Experimental Execution

• Based on a comprehensive understanding of the CMC lifecycle, develop downstream purification process development strategies and overall timelines, and drive effective execution of such strategies.
• Responsible for key process development decisions, including resin screening, new technology application, critical process parameter definition, process robustness assessment, and scale-up strategy formulation.
• Identify key technical challenges and risks during manufacturing scale-up (e.g., yield, purity, aggregates, HCP/DNA, viral safety, and scale-up risks), drive the development of solutions, and oversee their implementation.
• Collaborate closely with relevant functional teams (Analytical, Upstream, Manufacturing, etc.) to ensure consistency and executability of technical approaches and data outcomes.

3. Cross-functional Collaboration & Client Communication

• Serve as the primary internal and external interface for downstream projects; coordinate with Upstream (CCPD), Analytical Sciences (AS), Manufacturing Science and Technology (MSAT), Manufacturing (MFG), and other teams to facilitate smooth process development and scale-up activities.
• Organize and lead client communications, including requirements clarification, technical alignment, key risk identification and escalation, and delivery of key conclusions, to enhance client satisfaction and trust.
• Proactively drive issue closure and resource coordination in cross-functional collaborations to ensure overall project delivery efficiency.

Preferred Qualifications

• Experience with commercial or late-stage projects, such as PPQ support, GMP technology transfer, or regulatory filing support (IND/BLA module documentation, etc.).
• Experience supporting client audits or regulatory inspections.
• Modeling/statistical/digital capabilities (e.g., DoE, data analysis automation, or process digitalization project experience).
• Team management or project coordination experience, with the ability to simultaneously advance multiple project deliveries.

Other Requirements

• Solid knowledge of downstream process and purification platforms: Protein A, ion exchange, hydrophobic interaction, mixed-mode chromatography, viral inactivation/filtration, UF/DF, etc., with an understanding of DoE, process characterization, and scale-up logic.
• Strong communication and written expression skills in both Chinese and English; capable of independently organizing client meetings and drafting meeting minutes, technical reports, and summary materials.
• Quality and compliance awareness; familiarity with basic GMP requirements and deviation/change/investigation logic (depth may vary by position level).
• Data-driven analytical capabilities; able to support project decisions and management reporting based on data.