Scientist, Manufacturing Science and Technology, Purification

BeOne Medicines US Manufacturing Co., Inc.; Hopewell (VA); On-site; USD 90,000 - 120,000; Full time

Job summary

BeOne Medicines Ltd. is seeking a Scientist in Manufacturing Science and Technology, Purification, to support downstream unit operations and process transfer.

The role focuses on chromatography, filtration, viral inactivation, and unit operations while coordinating with cross-functional teams in an FDA/EMA-regulated environment. Applicants should have 2+ years in biotech, a relevant BA/BS, and strong data analysis, DOE design, and project management skills.

Qualifications

• BA/BS in chemical engineering, biochemistry, biotechnology, biology or related discipline.
• 2+ years of experience in life sciences/biotechnology industry.
• 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 root-cause analysis skills.
• Experience with technology transfer to/from clinical/commercial manufacturing facilities.
• Knowledge of DOE study design and reports.
• Proven planning and data analysis skills; statistical software experience.
• Project management skills for internal/external teams.
• Knowledge of cGMP FDA/EMA/ICH/PDA guidelines.
• Experience in purification lab or manufacturing.
• FDA/EMA regulatory knowledge for submissions.
• Strong written and oral communication in a multi-disciplinary environment.
• Proficiency with Microsoft Office and statistical tools.

Responsibilities

• Support downstream unit operations including chromatography and filtration.
• Monitor at-scale processes, report data, troubleshoot operations.
• Design and execute lab experiments; analyze data and generate reports.
• Support technology transfer and risk assessments across sites.
• Contribute to process improvements and compliance activities.

Skills

Chromatography

Filtration

Viral clearance

DOE study design

Data analysis

Root cause analysis

Project management

FDA/EMA regulations

Microsoft Office

JMP

Education

BA/BS in chemical engineering, biochemistry, biotechnology, biology

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.

It 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.
• 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. 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]. BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram. For more information, please visit the link to explore job opportunities in China Mainland. China Mainland Job Posting At BeOne, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things. Patients First Driving Excellence Bold Ingenuity Collaborative Spirit

Patients First Driving Excellence Bold Ingenuity Collaborative Spirit