Staff Scientist

BeOne Medicines; Hopewell (NJ); On-site; USD 114,000 - 155,000; Full time

Job summary

BeOne Medicines is seeking a Staff Scientist to join their Manufacturing Sciences & Technology team. This pivotal role involves technology transfer, process qualification, and compliance support, requiring expertise in chromatography and purification processes. The ideal candidate will have a strong background in life sciences and a passion for advancing cancer treatment.

Benefits

Comprehensive benefits package

401(k) plan

Employee Stock Purchase Plan

Qualifications

• Minimum of 5 years in Life Science/Biotechnology with a BS, or 4 years with an MS.
• Experience in a cGMP manufacturing environment.
• Knowledge of FDA, EMA, ICH regulations.

Responsibilities

• Lead data analysis and author various protocols and reports.
• Design experiments to support parameter classification.
• Support compliance-related activities and provide technical support.

Skills

Analytical Thinking

Data Analysis

Technical Writing

Education

BS in Life Science/Biotechnology

MS in Life Science/Biotechnology

Tools

Microsoft Office

SAP

Job description

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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

Reporting directly to the Director of Manufacturing Sciences & Technology (Purification), this position is pivotal within the MST Purification team. Responsibilities include technology transfer, campaign readiness, process qualification, monitoring, deviation/CAPA management, process improvement projects, and Continued Process Verification (CPV). The role requires expertise in unit operations such as chromatography, tangential flow, depth, viral and dead-end filtration, buffer preparation, and product quality analysis. Key duties involve leading data analysis, authoring protocols and reports, and designing experiments to support parameter classification and control ranges. The position also supports compliance-related activities and provides technical support to manufacturing.

Key Responsibilities

• Lead data analysis and author various protocols and reports.
• Design experiments to support parameter classification and control ranges.
• Support compliance-related activities and provide technical support to manufacturing.
• Author department standard operating procedures and ensure training of junior staff.
• Support regulatory filings by authoring required sections, responding to regulatory authority questions, and participating in inspections.
• Collaborate closely with Manufacturing, Supply Chain, Procurement, Quality Control, Quality Assurance, Regulatory, and Process Development groups.
  
  

Essential Job Functions

• Participate in cross-functional project teams supporting manufacturing and process development.
• Ensure a safe working environment.
• Author study protocols, reports, and documentation supporting deviations and regulatory activities.
• Perform technology transfer activities, including facility gap and risk assessments.
• Provide technical support as a SME for purification process implementation.
• Author technical transfer plans, process descriptions, control strategies, and campaign summary reports.
• Author process validation plans, PPQ protocols, and downstream study protocols to support PPQ.
• Perform CPV and process monitoring during campaigns.
• Communicate effectively with team members and stakeholders.
• Serve as Person-In-Plant (PIP) during critical manufacturing steps.
• Perform manufacturing data analysis.
• Support on-site supervision and management of contract employees or third parties as required.
  
  

Qualifications

• Minimum of 5 years in Life Science/Biotechnology with a BS, or 4 years with an MS.
• Demonstrated experience in a cGMP manufacturing environment and purification laboratory.
• Knowledge of drug preclinical, clinical, and commercial requirements.
• Familiarity with EMA and FDA regulatory requirements for submissions.
• Effective communication skills, both oral and written, in a multi-disciplinary, project-driven environment.
• Proficiency with software such as Microsoft Office and SAP.
• Expertise in Mab Facilities and Process Design/Development.
• Proficiency with large-scale downstream equipment (e.g., chromatography systems, tangential flow filtration, filtration, and analytical equipment).
• Experience with commercialization of large molecules and/or Mabs, including downstream process design, optimization, and tech transfer to clinical/commercial manufacturing facilities.
• Expertise in manufacturing data acquisition, process monitoring, and process historian (PI).
• Knowledge of FDA, EMA, ICH regulations and guidelines, and experience with regulatory inspections.
• Experience responding to regulatory requests for information.
• Subject matter expert in process statistical methods, process capability assessments (Cpk), and out-of-trend procedures.
• Strong analytical skills, including data analysis, detecting inconsistencies, and utilizing risk analysis tools.
• Expertise in study design (DOE) and authoring study protocols/reports.
• In-depth knowledge of GMP requirements.
• Proven planning and data analysis skills, including the use of statistical software.
• Project management skills for internal and external teams.
  
  

Physical Requirements

• Ability to reach above shoulder level, bend/stoop, push/pull, and handle/grip frequently.
• Ability to work scheduled 40 hours with the flexibility to work overtime as needed.
• Comfort working in varying temperatures.
• Ability to gown and work in manufacturing areas when required.
• Some reaching, bending, stooping, and twisting.
• Repetitive motion and substantial movement of the wrists, hands, and/or fingers.
• Environment requires dedicated gowns, depending on the area.
• Work with hazardous materials and chemicals.
• Willingness to work off-shift when required.
  
  

Supervisory Responsibilities

• None
  
  

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: $114,900.00 - $154,900.00 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. 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

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