主要职能 Primary Function:

The ideal candidate should thrive in a fast-moving, collaborative team setting. The candidate will work with both internal and external partners to support analytical and formulation development across multiple projects. Close cooperation with Research, Process Development, Manufacturing, Quality, and Regulatory teams is essential to advance products through clinical stages and ultimately towards BLA approval. Joining the vibrant, innovative Analytical Development and CMC teams offers ongoing learning opportunities and a chance for broad cross-functional growth, developing into a scientific and technical leader beyond one’s primary area of expertise.

主要职责 Major Responsibilities and Duties:

•Manage the analytical and formulation team and oversee all related activities in the Biologics CMC.

•Collaborate with cross-functional teams and stakeholders to advance the company's biologics pipeline. Represent Biologics CMC in global and technical meetings. 

•Contribute to strategic planning and the long-term development of Biologics CMC.

•Collaborate with internal and external labs to design, plan, and conduct analytical development for regulatory filings and applications.

•Offer guidance and supervision in creating and refining processes, both internally and in collaboration with external CRDMOs.

•Authors CMC sections for regulatory submissions and ensures all documents comply with GMP standards.

•Oversee the recruitment, training, development, and performance evaluation of personnel.

Required:

•Ph.D. in Pharmaceutical Sciences, Chemistry, Biochemistry, or related field with at least 5 years of analytical and formulation development experience

•Strong grasp of pharmaceutical regulatory standards

•Excellent written and spoken English and Mandarin

Preferred:

•Experience with biologics and sterile product formulations

•Skilled in solid dosage, injectables, and advanced drug delivery systems (e.g., PFS, autoinjector)

•Familiarity with Quality by Design (QbD) principles and statistical analysis tools.

Technical Skills and Soft Skills:

•Expertise in formulation software tools and analytical techniques such as HPLC, DSC, and Spectroscopy for formulation characterization

•With solid tracking record of solid formulation and process development, and regulatory dossier preparation experience to support IND or NDA or aNDA submissions.

•Proactive and collaborative mindset, fostering a culture of innovation and teamwork.

•Ability to thrive in a fast-paced, dynamic environment while managing multiple projects and priorities.