QC Associate Manager

About us

BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn and X (formerly known as Twitter).

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.

Job Description:

General Description:

The incumbent is responsible for Quality Control activities to provide support for the early-stage development and clinical production of Beigene’s Cell Therapy products, and ensuring adherence to supplemental local regulatory requirements.

Essential Functions of the job:

• Continuously build a highly efficient quality control laboratory.
• Create, maintain and archive all QC documents, including specification, test methods, standard operating procedures (SOPs), quality agreements, and test reports, etc.
• Establish and manage the raw material management system that encompasses setting raw material specifications, conducting release tests, and performing batch release.
• Handle QC related quality events, such as OOS, OOT, change control, trend reports, etc.
• Manage the test sample, reference standard and reagents.
• Perform in - process control testing, final product release and Stability testing.
• Oversee analytical equipment qualification and life cycle.
• Set up and perform microbiological testing procedures for raw materials, in-process products and final products to ensure product safety and compliance with specification.
• Work with contract testing lab and manage the out-sourced testing.
• Review the specification document and testing report for material/cell bank/product release.
• Plan and execute analytic method transfer, verification and validation.
• Develop and implement a comprehensive environmental monitoring program.
• Participate in department budget’s estimate and planning.

Qualification Required:

Education Required:

Bachelor degree or above, Major in Pharmaceutics, or biotechnology related

Core Competencies, Knowledge and Skill Requirements

• In-depth knowledge of PIC/S GMP, FDA, EMA, USP and EP guidance.
• Experience with regulatory compliance inspections.
• Knowledge of quality control on CGT is a plus.
• Familiar with flow cytometry, cytotoxicity, ELISA, qPCR/dPCR, etc.
• Knowledge of environmental monitoring and microbiological testing.
• Excellent verbal, written and interpersonal communication skills.
• Ability to analyze and resolve issues calmly under tight timeline and uncertainty
• Ability to work independently with departmental and interdepartmental subteams.

Communication & Interpersonal Skills

•  Good interpersonal skills, including listening, writing, negotiations, facilitation of discussions, possesses great attention to detail

Experience

• 3+ year pharmaceutical or biotechnology industry GMP experience
• 2+ years’ experience in quality control in CGT
• Experience in verification/validation of bioassay is plus
• Experience in microbial control of CGT
• Demonstrated experience in driving cross-functional project
• Agility in change
• Experience on tight timeline and uncertainty project of developing product is a plus
• Fluent English in spoken and written

What We Offer To Our Valued Employees

• Market competitive compensation package including performance-based annual bonus scheme
• Company shares (generous welcome grant and performance-based annual equity plan!)
• In-house and external learning and development opportunities
• Fantastic benefits program and keep improving!
• Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
• Join us and Make momentum in your career!

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

BeiGene is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.

Due to BeiGene’s global operation, job applicants’ data will be stored overseas with adequate protection. Besides, job applicants’ data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeiGene. For further details, please refer to BeiGene’s Job Applicant Privacy Policy (https://www.beigene.com/privacy-policy).

If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeiGene’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeiGene’s Job Applicant Privacy Policy as well as the relevant privacy terms.

If you have any concern, please DO NOT provide any resume or other personal information to us.