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.

Note: To be considered for our 2025 Summer Internship program you must be enrolled in a university degree program and cannot be graduating sooner than December 2025. 

Education Required: Enrolled in a bachelor’s degree program in a related scientific discipline

General Description:

This position is based in Hopewell, NJ.  Supports QA material inspection and QA Manufacturing activities, ensuring the successful day to day operations by supporting: logbook and documentation reviews, material inspection activities, document reviews, material complaint support, shop floor observations, and related Quality support activities. Works to support QA Key Performance Indicators (KPIs) such as SOP mandated cycle times, on time closure dates, and QA objectives, whilst adhering to regulatory compliance and achieving business success. Creates and/or reviews SOPs need to support the business.

Supports QA related tasks as assigned by QA Management.

Essential Functions of the job:

·       Ensuring all activities are performed in accordance with GMPs, SOPs and Health and Safety policies.

·       Gowns into classified areas to observe manufacturing operations in drug substance and drug product manufacturing.

·       Performs facility GEMBAs

·       Redline procedures and GMP documentation for future revision and process improvement initiatives

·       Revise documentation based on operational redlines during validation and/or engineering runs

·       Supports Warehouse and Material Release QA with material inspection against approved specifications.  Supports specification review.

·       Reviews GMP documentation for compliance with site procedures.

·       Generates KPI metrics for department, as needed

·       Supports Quality Assurance activities to ensure compliance with FDA/EU regulations.   

·       Supports QA Compliance of departmental SOPs (writing and/or revising), ensuring regulatory compliance in conjunction with being ‘fit for purpose’ operationally and commercially.

·       Awareness of USP/EP, ICH Guidelines, QC methodology updates to ensure compliance with current testing and specifications.

·       Ensuring appropriate escalation and follow up for non-conformities within GMP areas, and issuing deviations when appropriate.

·       Ensuring that the Quality department meets or improves key performance indicators (KPIs).

·       Undertaking any other duties for any department within the business, which may be requested by Management, for which training and/or an explanation has been provided and understood.

Core Competencies, Knowledge, and Skill RequirementsScientific degree in progressWorking knowledge of cGMPs:  21CFR parts 2010 & 211, knowledge of 21CFR600 – Biologics desirable.Preferred experience working with an ERP system, such as SAP, and eQMS systems such as Trackwise or Veeva.Good personal leadership skills and experience. Good collaboration ability.Credible and confident communicator (written and verbal).Customer focused, Strong analytical and problem-solving ability.Good project management skills.Hands-on approach, with a ‘can do’ attitude.Ability to prioritize, demonstrating good time management skills.Good 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.Highly Desirable:  Good IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project and Outlook)Significant Contacts

Interacts with primarily with peer levels of BeiGene employees

Computer Skills:

Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).Ability to work on a computer for extended periods of time

Other Qualifications:

 Must be able to work in the US without corporate sponsorship.

Travel:

None

Pay range: $27.50/hr (undergrad/bachelors)

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 TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with Clarity

Salary Range: $ - $ per hour

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.