Senior Project Manager, CMC

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:
This is an individual position for CMC and Project management of initial start of facility and tech transfer that requires advanced technology expertise in biological cell culture, purification and/or drug product process. Of equal importance, it is the ability to develop rapport internal and external to CMC.  This role will directly support Project Management, Technology Transfer, Regulatory Filings/Inspections. This position plays a PM and CMC leading role in Technology Transfer and CMC regulatory filings by setting clear objectives and empowering their team. This position involves close collaboration within regulatory CMC, MS&T, Process Development, Manufacturing, Quality Control, Quality Assurance, and Regulatory groups.

Technical/Skills Required:

• Project management skills related to internal and external teams for equipment CQV and technology transfer.
• Broad understanding of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation and drug product technologies, and distribution across multiple regions.
• Process and equipment knowledge related to cell culture and/or purification as well as analytical instruments commonly used in manufacturing
• Experienced in Tech Transfer and solving manufacturing related issues
• Accountable for availability of clinical and commercial supplies, timely development of high-quality regulatory filing content, development of robust manufacturing processes and analytical methods and completion of all necessary validation activities within a matrix structure with the expertise areas and external partners to deliver new drug applications in multiple markets.
• Experienced in the regulations and guidelines of the FDA, EMA, ICH, PDA
• History of supporting regulatory inspections.

Working Experience:

• BS or higher in science, biochemistry, biotechnology, biology, chemical engineering and/or related discipline
• 7+ years of experience in the pharmaceutical/biotechnology PM and CMC management of development and commercial programs
• Experienced in biological manufacturing upstream and/or downstream and/or drug product manufacturing development and production operations
• Ability to operate effectively within an entrepreneurial and science-driven company environment; self-motivated, delivery-oriented, assertive, able to inspire others, driven and hands-on with unquestionable integrity and the highest ethical standards
• Familiarity with EMA and FDA regulatory requirements for submissions
• Broad knowledge of drug development, CMC, preclinical and clinical requirements
• Experience in effectively managing scientific groups and projects
• Demonstrated effective communication, oral and written, in a multi-disciplinary, project-driven work environment
• Demonstrated skill in leading project teams tasked with resolving complex production related issues
• Good written and communication skills
• Familiar with software such as Microsoft Office including Microsoft Project, Visio, etc.

Physical Requirements:

• Must be able to stand for long periods, up to 8 to 10 hours/day
• Must be able to work scheduled 40 hours with the ability to work overtime as needed
• Must be comfortable in working in varying temperatures
• Environment requires dedicated gowns, depending on project schedule
• Willing to work any shift
• On-site work (not remote work)

Supervisory Responsibilities:  

• N/A

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range: $127,900.00 - $172,900.00 annually

BeiGene is committed to fair and equitable compensati