Job Description and Responsibilities：

The position of MSAT Sr. Manager/Associate Director is responsible for technology transfer, manufacturing technical support (on-site support to Phase III and commercial manufacturing, deviation investigations, change controls, CAPAs, and quality improvements), process validation and NDA/BLA filing.

This position will also provide advice and guidance on manufacturing technology issues, manufacturing capacity planning, process scale up, new facilities designing, and continuous improvement.

Manage MSAT site drug substance group, recruiting and coach the team members.

Lead/participate the technology transfer including the transfer from development department to GMP commercial sites, site to site, as well to external CMO/partner sites.

As the process owner, initiate risk assessment & mitigation plan during technology transfer and manufacturing.

Function as subject matter expert (SME), provide on-site technical support, and perform process monitoring, deviation investigation, troubleshoot investigation-driven events, and problem solving.

Develop and review manufacturing relative technical documents, such as process specification, control strategies, master batch records, in process sampling plan, microbial control strategies, change control proposals, deviation impact assessments.

Lead process validation and continued process verification

Draft and review NDA/BLA dossier (manufacturing process section), support PAI (Pre-approval Inspection) and GMP audits.

Trend analysis for commercial products and process monitoring.

Lead post approval process change, assess the impact to product quality and regulatory compliance

Oversight CMOs routine production activities and provide technical support.

Establish/utilize scale down model in laboratory to support deviation investigation, change control evaluation, new-sourced material qualification, process scale up and post-launch process optimization.

New technology exploration, support new facility design, process equipment selection and new facility start up.

Liaise with different commercial sites and clinical manufacturing groups to establish and implement best practices.

Network with other companies and industrial organization for benchmarking new manufacturing technologies



Qualifications:

Master or Ph.D, Chemistry, Pharmacy, Biology or equivalent major with minimum of 5+ year relevant experience in biologics process development or commercial manufacturing.

Having experience in upstream/downstream process development, process characterization, scale up or manufacturing.

Experience in CMC project management, CTD filing to EMA or FDA is preferred.

Experience in GMP production under NMPA, EMA and FDA regulations is preferred.

Good communication skills of both English and Mandarin (written and spoken).

Goal-oriented and adaptable, with the ability to model a corporate culture that emphasizes Quality, Speed, and Innovation.