General Description:
This role in the Manufacturing Science and Technology (MST) department supports BeOne's 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.
Required Leadership Skills:
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 BeOne's pipeline and product portfolio.
Required Skills/Experience:
Expert level knowledge in all Drug Product aseptic filling operation
Expert level knowledge of Isolator, packaging and automated inspection machines.
Lead technology transfer for cGMP manufacturing focused drug product fill/finish.
Expert level knowledge in IQ/OQ/PQ and process engineering
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.
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.
Education/Experience Required:
BA/BS or higher in science, biochemistry, biotechnology, biology, chemical engineering and/or related discipline.
Minimum of 8+ years of experience working in Biopharmaceutical DP process development or manufacturing experience.
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
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.
Other Qualifications: Health authority inspections (FDA, EMA, ICH regulations and guidelines). Execution and optimization of controlled procedures. Technical and business writing. Business process development.
Travel: International and domestic - periodically.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
