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.
We are seeking an exceptional and highly motivated CMC leader to join the BeiGene Cell Therapy team to enable the cell therapy development. Ideal candidate must be proficient in both CMC strategic planning, execution, and matrix team management. The successful applicant will spearhead the management of GTP/GMP facility, while develop internal cell therapy CMC capability including required resources, budgets, technology needs to enable programs.
Job Functions
- Strengthen internal cell therapy CMC capability by work with internal stakeholders and external partners to evaluate and enable cell therapy related GTP/GMP facility, along with delivering clinical material for cell therapy trials.
- Develop a vendor selection strategy to select services for development and manufacturing of discovery and oncology early development clinical assets.
- Plan, track, execute on programs from a pre-clinical stage through clinical proof of concept.
- Lead cross-functional team to author CMC/ quality sections of regulatory submissions (INDs/CTDs).
- Building scope and design of experiments as well as troubleshooting to generate robust GMP processes and analytics for cell therapy products.
- Assembling relevant CMC data and authoring regulatory filing documents (CMC sections) and responses to questions from regulatory agencies. Routinely supporting release of GMP batches of cell therapy products.
- Responsible for drug product management and generating and reviewing technical reports and technology transfer documents.
- Ensures effective communication and collaboration of all involved functions and third parties.
- Partnering and aligning with Discovery, Regulatory, Operations, Quality, and Clinical functions, and managing CMC-focused deliverables and timelines to move programs from lab to the clinic and beyond. Routinely presenting updates on CMC progress
Qualification
- Doctoral degree in biochemical engineering, bioengineering, biotechnology, or relevant process development and manufacturing of biologics.
- ≥8 years of industrial experience in CMC of biologics. Experience with cell therapies is a plus.
- Broad understanding of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation and drug product technologies, distribution across multiple regions.
- Excellent writing skills. Good understanding of iPSC related manufacturing processes and analytics is a plus
- Experience authoring SOPs, regulatory and quality documents.
- Experience working in cGMP manufacturing facilities and IND filing of biological products.
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: $207,500.00 - $287,500.00 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.
