Head of MSAT, China

Position Summary

We are seeking a visionary and experienced Head of Manufacturing Science & Technology (MSAT) to provide strategic and technical leadership for commercial manufacturing in a biologics CRDMO organization.

This role will cover technology transfer, process validation, material science, lifecycle management and Continued Process Verification (CPV) ensuring manufacturing robustness for Biologics modalities including monoclonal antibodies (mAbs), recombinant proteins, bispecific molecules and next‑generation biologics.

The incumbent will lead 100+ leaders, scientists and engineers at various levels to drive technical compliance and competence, accelerate commercialization, and ensure production reliability and cost competitiveness.

The role requires close cross‑functional collaboration with development, manufacturing, quality, supply chain and regulatory affairs to secure scalable, stable production from late‑stage development through commercialization.

Key Responsibilities:

Strategic and Organizational Leadership

Develop and execute MSAT strategy and annual plans aligned with the company’s growth, network expansion and commercialization objectives in China region.

Build and lead a high‑performance MSAT organization covering upstream, downstream, formulation interfaces (where applicable), drug substance and manufacturing science functions.

Drive organizational excellence through talent development, succession planning and capability building.

Establish a standardized framework for technical governance, risk management and lifecycle management, ensuring alignment with global/regional policies.

Serve as the senior technical representative in executive reviews, client governance meetings and regulatory inspections.

Commercial Manufacturing Technical Enabling

Provide technical guidance and on‑site support for commercial biologics manufacturing; lead complex investigations, root cause analysis, CAPA and deviation resolution.

Improve manufacturing success rates, process robustness and continuous improvement; support batch release and lot release strategies.

Work closely with operations and quality to enhance operational efficiency, reduce cycle times and increase manufacturing reliability.

Technology Transfer and Process Validation

Own the end‑to‑end technology transfer plan and implementation for late‑stage technology transfers from development / clinical into clinical and commercial manufacturing sites.

Oversee the development and execution of Process Performance Qualification (PPQ), engineering runs, comparability studies and validation strategies to ensure successful local manufacturing/scale‑up/out.

Ensure scale‑up and scale‑out activities are executed smoothly across multi‑site network using science‑ and risk‑based validation approaches.

Process Lifecycle Management and CPV

Establish and oversee CPV programs and statistical process monitoring systems to support long‑term product compliance.

Lead pre- and post‑market change management, process optimization, yield improvement and cost‑reduction initiatives to drive manufacturing cost efficiency.

Define and execute lifecycle management strategies that meet regulatory requirements and global expectations.

Technical Innovation and Digitalization

Drive adoption of advanced manufacturing technologies such as intensified/continuous bioprocessing, perfusion/high‑density culture, Process Analytical Technology (PAT), real‑time release (RTR), AI‑driven process monitoring and digital twins, advanced analytics and automation platforms.

Enable local pilots and scale‑up of next‑generation manufacturing platforms to improve scalability, speed and cost efficiency.

Customer and Regulatory Interface

Act as the senior technical liaison for customers, on‑site audits and regulatory inspections; support technical exchanges and inspection responses with regulatory authorities.

Support regulatory submissions (including INDs, marketing authorization/biologics license applications, supplements and post‑market changes).

Build and maintain technical trust with clients and participate in technical support and commercial expansion activities for late‑stage projects.

Qualifications

Education

PhD, MS, or equivalent advanced degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Biochemistry, or related scientific discipline preferred.

Experience

15+ years of experience in biologics process development, MSAT, manufacturing sciences, or technical operations within the biotechnology, pharmaceutical, or CRDMO industry.

Significant leadership experience managing regional technical organizations and cross-functional teams.

Demonstrated experience supporting commercial biologics manufacturing and late-stage programs.

Deep expertise in:

Upstream and downstream bioprocessing

Process validation and PPQ

Technology transfer

CPV and lifecycle management

Regulatory inspections and filings

Experience with mAbs and other complex biologics; candidates with experience working across multi‑site/multi‑factory networks are preferred.

English proficiency to support communication with global teams and international clients is preferred.

Preferred

Strong understanding of FDA, EMA, ICH, and global GMP regulatory expectations.

Proven track record driving manufacturing robustness, operational excellence, and technical innovation.

Demonstrated success leading large-scale technical investigations and commercialization programs.

Experience implementing digital manufacturing, PAT, automation, or AI-enabled process systems.

Strong business acumen with experience supporting P&L, client engagement, and strategic growth initiatives.

Leadership and Personal Attributes

Strategic mindset with a broad perspective able to align regional goals with corporate strategy.

Strong execution orientation and ability to influence at senior levels; excellent communication and reporting skills.

Deep technical expertise balanced with pragmatic decision‑making and the ability to weigh tradeoffs in complex situations.

High sense of responsibility and results orientation; ability to drive cross‑functional change to completion.

Collaborative, customer‑focused and performance‑driven management style.

Why Join Us

Join a rapidly growing global biologics CRDMO at the forefront of innovation, commercialization, and next-generation manufacturing technologies. This role offers the opportunity to shape the future of biologics manufacturing while leading world-class technical organizations supporting life-changing therapies worldwide.