BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. BeOne 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:
Manages and supports the analytical development and QC activities at designated Contract Manufacturing Organizations. This includes working with CMO Quality as a QC representative to review and approve technical documents such as stability reports, analytical procedures and analytical record reviews. Manage and support product development and commercial global launches by serving as analytical/QC SME in the areas of method qualification/validation/transfer, specification development and management, stability studies, shelf-life updates and associated change control. Support global projects improve analytical/QC related systems and processes.
Essential Functions of the job:
- Perform QC review on specifications, analytical record, CoAs, stability protocols and reports, and other technical documents.
- Manage stability studies at CMOs
- Manage methods transfer and methods validation activities to CMOs, including transfer/validation strategy and approval of protocols and reports.
- Maintain proactive engagement with QC counterpart at the CMO.
- Support CMC activities at CMO as necessary.
- Provide QC oversight on assigned development and commercial projects.
- Ensure current projects are in compliance with BeOne SOPs.
- Support Global Quality Systems and Global Standards implementation.
- Assess and revise, as needed, SOPs for GMP Quality functions and identify opportunities to streamline systems and processes.
- Perform duties as assigned to ensure compliance to global and local regulations.
Core Competencies, Knowledge and Skill Requirements
- 5+ years working experience and 2 years team management experience in an FDA-regulated pharmaceutical company.
- Expert with pharmaceutical analytical and microbial testing and related equipment/instrument.
- Familiar with the USP/EP and the cGMP/EU GMP.
- Wide knowledge of analytical methods and electronic systems.
- Strong leadership/team management skills and experience.
- Credible and confident communicator (written and verbal) at all levels.
- Strong analytical and problem-solving ability.
- Excellent project management skills.
- Hands-on approach, with a ‘can do’ attitude.
- Ability to prioritize, demonstrating good time management skills.
- Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
- Self-motivated, with the ability to work proactively using own initiative.
- Committed to learning and development.
Significant Contacts
- Interacts with all levels of BeiGene employees including CMOs and suppliers.
Project Management - Communicates changes and progress; Completes projects on time and budget.
Computer Skills:
- Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)
Other Qualifications:
5+ years' experience with Bachelor of Arts, or 4+ years with above degree in a related scientific discipline. 2+ years with PHD.
Travel:
- Must be willing to travel approximately 5%
- Ability to work on a computer for extended periods of time
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, 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: $108,100.00 - $148,100.00 annually
BeOne 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. BeOne 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
BeiGene Cambridge, Massachusetts, USA Office
55 Cambridge Parkway, Suite 700W, Cambridge, MA, United States, 02142
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