Senior Director of Process Development and MSAT

Job Title:
Director /
Senior Director, Process Development and MSAT

Location:
China - travel required

Company:
leading CDMO

We are working with a global, leading CDMO company who are seeking an accomplished and forward-thinking
Senior Director of Process Development and Manufacturing Science & Technology (MSAT)
to lead technical strategy and operations across their biologics development and manufacturing network in
China
.

This leader will oversee end-to-end process development, scale-up, and lifecycle management, ensuring reliable, compliant, and globally competitive manufacturing processes to support all manufacturing locations in China.

Key Responsibilities

• Provide
  strategic and technical leadership
  for Process Development and MSAT teams supporting biologics drug substance and drug product programs.
• Lead the design, optimization, and
  scale-up of robust, efficient, and GMP-compliant manufacturing processes
  for upstream, downstream, formulation, and fill-finish operations.
• Direct
  technology transfer activities
  between R&D and manufacturing sites in China and globally, ensuring smooth transition and knowledge retention.
• Oversee
  process characterization, validation, and continued process verification (CPV)
  to meet regulatory standards (NMPA, FDA, EMA, and ICH guidelines).
• Drive
  innovation in process and manufacturing technology
  , including automation, digitalization, PAT, and continuous manufacturing approaches.
• Partner with
  Quality, Regulatory, and Operations
  teams to support global regulatory submissions, audits, and inspections.
• Provide
  technical governance and oversight
  for commercial manufacturing operations, troubleshooting, and process improvement initiatives.
• Manage departmental budgets, resources, and technical project portfolios in line with corporate and global strategy.
• Build, mentor, and develop a high-performing technical team in China, fostering a culture of scientific rigor, collaboration, and operational excellence.

Qualifications

• Ph.D. or Master's degree in
  Chemical Engineering, Biochemistry, Biotechnology, or related discipline
  .
• Minimum of
  12–15 years of experience
  in process development, MSAT, and manufacturing support within the
  biopharmaceutical industry
  , with at least
  5 years in a senior leadership role
  .
• Proven track record in
  biologics process development and technology transfer
  from clinical to commercial scale.
• Strong knowledge of
  GMP operations
  ,
  process validation
  , and
  global regulatory requirements
  (NMPA, FDA, EMA, ICH).
• Demonstrated experience managing
  cross-functional and cross-site teams
  in a global or multinational environment.
• Excellent
  leadership, communication, and stakeholder management
  skills, with the ability to collaborate effectively across cultures.
• Fluency in
  English and Mandarin
  preferred; ability to work effectively with global teams and partners.

Desirable Attributes

• Experience in
  late-stage and commercial biologics programs
  , including lifecycle and cost optimization.
• Exposure to
  emerging modalities
  such as ADCs, bispecific antibodies, fusion proteins, or mRNA-based therapeutics.
• Strong strategic mindset, with an emphasis on
  innovation, quality, and continuous improvement
  .