Senior Specialist, Drug Product Commercial Small Molecule, External Supply Quality

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:

The incumbent will report to the Associate Director, Drug Product Commercial Small Molecule, External Supply Quality and be responsible for supporting activities relating to BeiGene’s external GMP operations in the US as well as internal BeiGene GMP processes, ensuring procedures and systems are in place to support BeiGene’s commercial products.

The incumbent will provide support in ensuring that commercial products are manufactured, packed, labelled, distributed, and controlled in accordance with regulatory expectations and applicable quality standards.

Essential Functions of the job:

• Batch Record review and release preparation of commercial APIs, primary packed products and finished products manufactured by contract manufacturers on behalf of BeiGene.
• Follow up on and asses CMO deviations and other issues
• Assess change controls, perform change actions and follow up on change status
• Monitor CMO performance metrics
• Close collaboration with BeiGene's Manufacturing, Supply Chain and Regulatory teams
• Support the update of Quality Agreements with BeiGene’s external partners
• Lead or support quality document updates.
• Perform other tasks as assigned in accordance with SOPs, regulatory agencies and GxP guidelines and provide support to cross-functional teams when needed.

Experience:

• At least 4 years pharmaceutical or biotechnology industry experience.
• GMP experience in a quality function.
• Commercial QA experience preferred.

Core Knowledge and Skill Requirements:

• Knowledge of Quality principles, concepts, industry practices and standards.
• Working Knowledge and experience with 21CFR210, 21CFR211, ICHQ7 as well as international regulations.
• Excellent verbal, written and interpersonal communication skills.
• Ability to work independently with scientific/technical personnel.
• Apply principles of logical and scientific thinking to a wide range of intellectual and practical problems.
• Excellent interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail.
• Spoken/Written fluency in English required

Computer Skills:   

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
• Experience with electronic quality management systems preferred
• Ability to work on a computer for extended periods of time

Education Required:

Bachelor’s degree in science or combination of education and equivalent work experience

Travel: 

• May travel approximately 5 - 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

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.