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 role provides a good opportunity for setting a new analytical lab and engaging analytical test method transfer for late phase clinical phase/commercial products as a senior analytical scientist in BeiGene Manufacturing Science and Technology team (MST) located in Hopewell NJ. The senior scientist will manage equipment IOQ, then design, execute, and document comparability test for analytical method. Also, the test for small scale samples from MST upstream and downstream parts by transferred analytical method. The position requires experience in quality control team or analytical team in process development or similar team in biological pharmaceutical or life science company. The candidate must have experience working with cross-functional stakeholders and demonstrated ability to thrive in a fast-paced, matrixed environment.
Essential Functions of the job:
- Planning, implementing, and reporting technical transfer for physiochemistry and biochemistry methods (using LC, ELISA, CE, and qPCR).
- Preparing documents such as test methods, test record, standard operation procedure, protocol, and report.
- Managing analytical equipment from installation and operation qualification (IOQ) to periodical preventive and maintenance (PM).
- Cross functional work with production, QC, QA, Engineering, procurement, and supply chain.
- Capability to work with the other site stakeholders in different time zone.
Qualifications:
- Master’s degree with 2+ years of experience or Bachelor’s degree with 4+ years of experience
- Experience of quality, regulations, and compendial methods
- Experience on technical transfer for non-GMP or GMP production
- Understanding of physiochemistry and biochemistry analysis for monoclonal antibody in terms of Process Analytical Technologies (PAT)
- Communication skills and work in cross-functional teams in various geographic locations in different time zones
- Solid understanding of Good Manufacturing Practice (GMP) and data integrity
- Excellent technical writing skill in test methods, technical documents
- Hands on experience on physiochemistry, biochemistry tests
- Experience for cell-based assay and protein characterization are beneficial (using LC-MS, CD, SPR)
Computer Skills:
- Waters Empower, JMP, LIMS, Microsoft Office (Word, Excel, PowerPoint, Visio, Project)
Other Qualifications:
- 4+ years of experience working in quality team or analytical development team for biopharmaceutical or any biomolecular production related life science industries.
- Work experience with cross-functional stakeholders and demonstrated ability to thrive in a fast-paced, matrixed environment.
Travel:
- Must be willing to travel approximately 10%.
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: $93,000.00 - $128,000.00 annually
BeiGene is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
Top Skills
What We Do
BeiGene is a global biotechnology company that is developing and commercializing innovative and affordable oncology medicines to improve treatment outcomes and access for far more 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 8,500 colleagues spans five continents, with administrative offices in Beijing, China; Cambridge, U.S.; and Basel, Switzerland. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneGlobal.
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