Manufacturing Control (MC) Lead

WuXi Biologics; New Jersey; On-site; USD 120,000 - 150,000; Full time

Job summary

A leading biotechnology company in New Jersey is seeking a Director for global technical leadership in manufacturing projects. The ideal candidate will lead technology transfer and ensure quality compliance in production. An advanced degree and extensive experience in biomanufacturing is required. The role involves project management, client support, and cross-functional collaboration. Candidates should be willing to travel and work in international locations.

Benefits

Opportunities to develop CMC experience

Dynamic work environment

Cross-functional collaboration

Qualifications

• Advanced degree (PhD or MS) in Bio/Chemistry, Bio/Chemical Engineering, Biotechnology, Life Science or related major with 8+ years of applicable work experience.
• Good knowledge and experience in CMC strategy, risk and resource management.
• Excellent project management and communication capability.

Responsibilities

• Provide global technical leadership to integrate and streamline technology transfer activities.
• Lead the technology transfer of late-stage projects and develop good regulatory filing strategies.
• Guide the process validation, equipment verification, and environmental monitoring.

Job description

Overview

Direct message the job poster from WuXi Biologics

Responsibilities

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.

About WuXi Biologics / Why join

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

Required Qualifications

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

Seniority level

• Director

Employment type

• Full-time

Job function

• Project Management

Industries

• Pharmaceutical Manufacturing