Head of Protein Science and Process Development

13 hours ago

Taipei Taipei City, Taiwan PharmaEssentia Corp. Full time NT$2,000,000 - NT$2,500,000 per year

About the job

We are seeking an experienced and strategic scientific leader to join our R&D leadership team as the Head of Protein Science and Process Development. The successful candidate will bring deep technical expertise in biologics development, strong leadership capabilities, and a proven track record of advancing biologic candidates through the development lifecycle. This position will lead cross-functional teams responsible for developing robust, scalable, and compliant manufacturing processes for Discovery Research, Clinical, and Commercial Productions.

Key Responsibilities

  • Lead the preclinical production team to support discovery research by enabling early-stage protein candidate screening and evaluation across a diverse biotherapeutics pipeline, including cytokines, monoclonal antibodies, and bispecific proteins.
  • Lead and manage all CMC Process Development activities (cell line, cell culture, purification, analytical, and formulation development) for protein-based biotherapeutic products using E. coli and CHO expressing systems.
  • Implement technological tools to enhance product development, scaling, and troubleshooting processes. This includes utilizing Design of Experiments (DoE) and conducting thorough risk assessments.
  • Oversee the technology transfer to GMP manufacturing facilities to ensure consistent performance in both clinical and commercial production.
  • Contribute to CMC strategy, ensuring robust, scalable, and regulatory-compliant processes to support IND/IMPD and commercial production.
  • Collaborate with quality, regulatory, and manufacturing teams and ensure compliance with ICH, FDA, EMA, and other global regulatory requirements for organizational & pipeline milestone deliverables.
  • Work closely with cross-functional teams in discovery, pharmacology, toxicology, quality, regulatory, and program management to align scientific strategy with project milestones.
  • Develop compelling team vision and strategies for sustained technology platform innovation and operational excellence.
  • Participate in R&D leadership discussions and work with executive management to drive strategic alignment, resource planning, and execution of development programs.

Qualifications

  • Ph.D. in Biochemistry, Chemical Engineering, or a related field.
  • Minimum of 10 years of industry experience in biologics development, including CMC leadership from early development through IND submission.
  • Experience in GLP/GMP production, successful IND/BLA CMC submissions and regulatory GMP inspections.
  • Extensive expertise in protein expression and purification across multiple expression systems, including GLP/GMP-compliant production; well-versed in novel bispecific and multifunctional biotherapeutic formats.
  • Strong background in CMC strategy for biologics, including formulation and analytical method development to meet regulatory expectations.
  • Familiarity with regulatory requirements and documentation for early-stage biologics development and IND filings.
  • Proven team management experience, preferably with oversight of 20+ scientists across multiple functional areas.
  • Experience with AI- or automation-enabled CMC technologies is highly desirable.
  • Knowledge of protein engineering and optimization is a strong plus.
  • Knowledge in cell therapy and ADC manufacturing is a plus
  • Demonstrated ability to operate in a fast-paced, matrixed biotech environment with cross-functional collaboration.

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