Scientist, Manufacturing Science and Technology, Cell Culture (Hopewell, NJ)

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 position is a critical role within the MST Cell Culture laboratories and activities may include but are not limited to Media Preparation Inoculum Seed/Production Cultivation and Harvest process therefore previous experience is preferred. The position will be responsible for design and execution of laboratory experiments data analysis and authoring of various reports. This position reports directly into the Associate Director Manufacturing Science and Technology (MST) Cell Culture and is located at the Hopewell NJ site.

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

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

Working in Cell Culture MST provides a unique growth opportunity for professional exposure to many facets of process development and drug substance manufacturing. This position involves close collaboration with Manufacturing Supply Chain Procurement Quality Control Quality Assurance Regulatory Process Development groups and MST counter parts located in other sites and addition as BeOne Hopewell continues to progress many unique opportunities and challenges will occur for anyone who is looking for career advancement.

Essential Job Functions:

• Participate in cross-functional projects teams that provide tech support to manufacturing and process development and able to present data and study findings in coherent manner.

• Ensure a safe working environment.

• Responsible for execution of laboratory experiments and maintaining support laboratory activities.

• Author study protocols and reports and other documentation supporting deviations and regulatory activities.

• Perform tech transfer activities including facility gap and risk assessments.

• Provide technical support as SME for implementation of cell culture processes.

• Author technical transfer plans process descriptions control strategies and campaign summary reports.

• Author Process validation plan PPQ protocols and various upstream study protocols to support PPQ.

• Perform Continued Process Verification (CPV) and process monitoring during campaigns.

• Effective communication with team members and stakeholders is a must.

• Serve as Person-In-Plant (PIP) during critical steps of the manufacturing process when required.

• Perform manufacturing data analysis as required.

• Any other assignments as are determined by the manager.

Education/Experience Required:

• BA/BS in science biochemistry biotechnology biology chemical engineering and/or related discipline with 2 years of Life Science/Biotechnology experience required

• Knowledge of Mab Facilities and Process Design / Development.

• Knowledge of biopharmaceutical equipment qualification and Validation activities.

• Cell culture knowledge including inoculum processes bioreactor systems harvest processes and analytical equipment.

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

• Experience with tech transfer to clinical/commercial manufacturing facilities.

• Knowledge of study design such as DOE and authoring of study protocols / reports.

• Good understanding of GMP requirements.

• Proven planning and data analysis skills use of statistical software to analyze data

• Project management skills related to internal and external teams

• Knowledge of regulations and guidelines of FDA EMA ICH PDA.

• Demonstrated experience working in cell culture laboratory or equivalent.

• Knowledge of drug preclinical clinical and commercial requirements.

• Familiarity with EMA and FDA regulatory requirements for submissions.

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

• Experience with software such as Microsoft Office JMP or SAP.

Computer Skills:

• Strong PC literacy required; MS Office skills (Outlook Word Excel PowerPoint).

• JMP or equivalent

• SAP or equivalent

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.

• Willing to work off shift when required.

Travel: Some travel may occur as a result of duties assigned to the role up to 20%

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

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 .