Principal Scientist, Drug Product

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 role in the Manufacturing Science and Technology (MST) department supports BeOnes Drug Product Manufacturing Technology Transfer and support. based in New Jersey (Hopewell) this role will be to lead the Hopewell drug product MST function to support technology transfer validation continued process verification investigations change management and site startup of Hopewell internal drug product manufacturing activities. Reporting to the MST leadership this role is responsible for managing the technical operations supporting both clinical and commercial manufacturing activities.

Leadership:

• Serve as MST DP SME and process lead for drug product ensuring the materials strategy and documentation are in place.
• Collaborate with DP/SC/QC/QA to develop testing strategy for DP raw materials and in-process samples.
• Author and maintain process control strategy documents throughout the lifecycle of a program and maintain process risk assessment documents.
• Author PPQ protocols and reports. Oversee execution of PPQ and PPQ related activities
• Support engineering teams on equipment selection qualification and start up activities.
• Monitor and CPV trend process performance including input and output parameters.
• Responsible for technical transfer validation investigation and technical support of aseptic manufacturing operations in Hopewell and CMOs. Collaborate with Drug Product Operations to establish robust and compliant manufacturing performance.
• Collaborate with Global DP MS&T and Technical Development to enable new DP filling capability at Hopewell Location.
• Provide technical support for Drug Product Operations. Provide input into operational metrics budgeting and planning.
• Establish a data and metrics driven culture. Relentlessly maintain alignment with other global manufacturing sites through shared knowledge shared manufacturing data shared manufacturing issues and common solutions.
• Partner with GZ Technical Development to successfully transfer and validate HPW DP processes. Product scope includes parenteral vials and lyophilized products. Collaborate with Technical Development in investigating and resolving complex manufacturing issues at CMOs.
• Manage and coordinate global change ensuring stakeholders alignment. Assist in Regulatory filings and Health Authority site inspections to license and maintain BeOnes pipeline and product portfolio.

Essential Functions:

• Lead technology transfer for cGMP manufacturing focused drug product fill/finish.
• Ensure effective information flow risk assessment timeline execution issue resolution and documentation for cross-functional teams. Includes leading tech transfer detailed process definition and facility fit assessment exercises.
• Execute scale down model of manufacturing processes. Maintains a good laboratory practice.
• Author and maintain process control strategy documents throughout the lifecycle of a program and maintain process risk assessment documents
• Author PPQ protocols and reports. Oversee execution of PPQ and PPQ related activities
• Support engineering teams on equipment selection qualification and start up activities.
• Monitor and trend process performance including input and output parameters.
• Investigate root causes of major deviations for cGMP manufacturing and implement CAPA for major deviations
• Identifying opportunities to improve systems and practices
• Work with counterparts in Process Development Process Sciences Manufacturing Quality Project Management teams etc. to facilitate technology transfer and project success.

Preferred Skills/Experience

• Facility Start-Up
• Commissioning Qualification & Validation
• Equipment and/or Process Design
• Quality Risk Assessments
• Health Authority Interaction/Audits
• OE and/or LEAN Methodologies
• Distributed Control system / Control Systems
• Deviation Assessments / Investigations
• SAP LIMS CMMS Veeva
• Expert level knowledge in all Drug Product aseptic filling operation
• Expert level knowledge of Isolator packaging and automated inspection machines.
• Expert level knowledge in IQ/OQ/PQ and process engineering
• Expertise in late stage/commercial Drug Product technology transfer process characterization and process validation biopharmaceutical/gene transfer vector manufacturing preferred.
• Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing.
• Ability to work both independently and as part of a team.
• Ability to function in a fast-paced dynamic team environment and balance prioritize multiple projects
• Excellent troubleshooting skills and ability to solve complex technical issues. Ability to compile analyze and interpret data; Ability to write routine reports and correspondence.
• Strong interpersonal and communication skills verbal and written. Ability to speak effectively before groups of customers. Ability to communicate in a dynamic environment.

Qualifications:

• BA/BS or higher in science biochemistry biotechnology biology chemical engineering and/or related discipline.
• Minimum of 7 years of experience working in Biopharmaceutical DP process development or manufacturing experience.

Physical Requirements:

• Must be able to stand for long periods up to 8 to 10 hours/day.
• Must be able to reach above shoulder level bend/stoop push/pull and handle/grip frequently.
• Must be able to work scheduled at least 40 hours/week (on-site).
• Must be comfortable in working in varying temperatures.
• Frequent lifting pushing pulling and carrying. Ability to lift up to 40 lbs.
• Regular 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 hazardous materials and chemicals.

Computer Skills: Familiarity with computer-based systems. Word Excel and PowerPoint a must.

Travel: International and domestic periodically.

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 .