Scientist, Manufacturing Science and Technology, Purification

BeiGene; Hopewell (NJ); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

401(k)

Equity awards

Employee stock purchase plan

Wellness program

Job summary

BeOne Medicines Ltd. seeks a Scientist in Manufacturing Science and Technology (Purification) to lead purification operations, develop scalable processes, and support technology transfer from development to manufacturing.

You will work with chromatography, filtration, viral clearance, and GMP-compliant documentation across multiple teams. The role emphasizes data analysis, problem solving, and cross-functional collaboration with Drug Substance Manufacturing, Quality, Regulatory, and other BeOne

Qualifications

• BA/BS in chemical engineering, biochemistry, biotechnology, biology, and/or related discipline.
• 2+ years of relevant experience in life sciences/biotechnology industry is required.
• Knowledge of monoclonal antibody facilities and process design and development.
• Knowledge of biopharmaceutical equipment qualification and validation activities.
• Purification knowledge including chromatography operations, filtration operation, viral clearance concepts, and drug substance stability.
• Familiarity with stainless-steel large-scale equipment and single-use systems.
• Data analysis and risk management abilities.
• Experience with technology transfer to/from clinical/commercial manufacturing facilities.
• DOE study design and study/report writing.
• Proven planning and data analysis skills and statistical software usage.
• Project management across internal and external teams.
• Knowledge of cGMP FDA/EMA/ICH/PDA guidelines.
• Experience in purification laboratory or manufacturing.
• Understanding preclinical/clinical/commercial requirements.
• FDA/EMA regulatory submission familiarity.
• Effective oral and written communication in a multidisciplinary team.
• Proficiency with Microsoft Office and JMP or similar tools.

Responsibilities

• Monitor at-scale purification processes and report data.
• Troubleshoot operations and support technology transfer.
• Design and execute laboratory experiments; analyze data.
• Prepare process descriptions, control strategies, and related reports.
• Collaborate with Drug Substance Manufacturing, Quality, Regulatory, and MST counterparts at other sites.

Skills

Data analysis

Root cause analysis

DOE study design

Project management

Regulatory knowledge

cGMP knowledge

Statistical software

Communication skills

Team collaboration

Process development

Education

Chemical engineering degree

Biochemistry/Biotech background

Tools

JMP

Microsoft Office

Job description

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:

This Scientist, Manufacturing Science and Technology, Purification position is a critical role within the MST Purification person-in-plant and MST laboratories specifying and supporting downstream unit operations, such as chromatography, normal and tangential flow filtration, viral inactivation, buffer preparation, drug substance fill and long-term frozen storage. Previous experience with these is preferred. The position will be responsible for monitoring at scale-process, reporting on process data, and troubleshooting operation. The function supports design and execution of laboratory experiments, data analysis and authoring of various reports. This position reports directly to the Director, Manufacturing Science and Technology (MST) Purification at the Hopewell, NJ site.

The position will support process improvements, troubleshooting, and compliance related activities and provide technical support to Drug Substance manufacturing. Process monitoring and trend analysis of manufacturing operations will be a key activity required for the position.

The position will be involved with technology transfer activities through the lifecycle of a project, generating technical transfer plans, performing gap and risk assessments, process descriptions and control strategies, related protocols and reports, and continuous process verification.

Working in MST Purification provides a unique growth opportunity for professional exposure to large-molecule process development and drug substance manufacturing. This position involves close collaboration with Drug Substance Manufacturing, Supply Chain, Procurement, Quality Control, Quality Assurance, Regulatory, Process Development groups and MST counterparts located in other sites and countries. **** In addition, with advancement in BeOne large-molecule pipeline, unique opportunities and challenges will be presented for career advancement.

Qualifications:

· BA/BS in chemical engineering, biochemistry, biotechnology, biology, and/or related discipline

· 2+ years of relevant experience in life sciences/biotechnology industry is required.

· Knowledge of monoclonal antibody facilities and process design and development.

· Knowledge of biopharmaceutical equipment qualification and validation activities.

· Purificationknowledge including chromatography operations, filtration operation, viral clearance concepts, and drug substance stability

· Familiarity with stainless-steel large-scale equipment and single-use systems.

Ability and aptitude for analyzing data, detecting inconsistencies, determining relative importance, conducting root cause analysis,and risk management.

· Experience with technology transfer to/from clinical/commercial manufacturing facilities.

· Knowledge of DOE study design and authoring of study protocols / reports.

· Proven planning and data analysis skills, and statistical software analysis.

· Project management skills related to internal and external teams.

· Knowledge of cGMP regulations and guidelines of FDA, EMA, ICH, PDA.

· Demonstrated experience working in purification laboratory or manufacturing.

· Knowledge of preclinical, clinical and commercial requirements.

· Familiarity with FDA and EMA regulatory requirements for submissions.

· Effective oral and written communication in a multi-disciplinary, project-driven work environment.

· Experience with Microsoft Office suite, JMP or other statistical software.

Physical Requirements:

· Must be able to reach above shoulder level, bend/stoop, push/pull, and handle/grip frequently.

· Must be able to work scheduled 40 hours with the ability to work overtime as needed.

· Must be comfortable in 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 area.

· Work with potentially hazardous materials and chemicals.

· Expected to work nights or weekend intermittently, as projects progresses.

Global Competencies

• 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: $90,400.00 - $120,400.00 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 BeOne Medicines 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [e-mail].