MSAT/MC Lead (Late Stage Tech Transfer & CMC Lifecycle Management)

1. Provide global technical leadership to integrate and streamline technology transfer activities and control strategies within company global MFG network and across projects.
2. Lead the technology transfer of late-stage projects, including the identification and assessment of risks in technology, process, quality, and regulations, and develop good regulatory filing strategies.
3. Lead the activities of facility fit, safety risk assessment for new product introduction and site change of late-stage projects.
4. Guide the process validation, equipment verification, and environmental monitoring.
5. Lead the development of manufacturing strategy, as well as the implementation, optimization and completion of production plan and product quality control for late-stage and commercial projects.
6. Lead the continuous monitoring of commercial production and the management of the product lifecycle. Identify areas for improvement and implement measures to improve efficiency and reduce production costs.
7. Guide the deviation investigation and change control for late-stage and commercial projects.
8. Provide support for clients and regulatory audits and lead the team to respond to audit related questions and implement corrective actions to address audit findings.
9. Promote good customer relationship and explore customer business needs and support contract proposal and discussion along with BD team for late-stage projects.

Opportunities:

1. Join a highly dynamic CRDMO company with locations in China, APAC, Euro and USA
2. Working with cross-function teams with deep scientific and GMP manufacturing expertise
3. Offered opportunities to utilize and develop your CMC experience in the pharmaceutical industry from process develop, tech transfer, and commercialization
4. Develop strong leadership and communication skills to facilitate contributions from different functions

1. Advanced degree (PhD or MS) in Bio/Chemistry, Bio/Chemical Engineering, Biotechnology, Life Science or related major with 8+ years of applicable work experience.
2. Good knowledge and experience in CMC strategy, risk and resource management, tech transfer, process qualification, biomanufacturing, deviation investigation, regulatory filing and life cycle management.
3. Excellent project management and communication capability.
4. Willingness to travel up to 10%
5. Be willing and able to work in China and other countries

Preferred (but not required) Qualifications:

1. Experience in two or more functional areas in Project Management, Cell Line Development, Cell Culture, Purification, Analytical, Formulation, Manufacturing, Manufacturing Support, QC or QA in the biologics industry.
2. Ability to effectively work across all levels, functions and sites.
3. Excellent verbal and written communication skills in both English and Chinese.
4. Ability to work on multiple late-stage and commercial projects at the same time.

Keywords: MC, MSAT, MS&T