BeOne Medicines
Associate Director, Drug Product, Manufacturing Sciences and Technology
BeOne Medicines, Pennington, New Jersey, us, 08534
General Description:
This role in the Manufacturing Science and Technology (MST) department supports BeOne's Drug Product Manufacturing site in New Jersey (Hopewell). This role will lead the site drug product MST function to support technology transfer, validation, continued process verification, investigations, change management and manufacturing startup. Reporting to the MST leadership, this role is responsible for managing the technical operations supporting both clinical and commercial manufacturing activities.
Essential Functions:
Serve as MST DP Subject Matter Expert (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 related activities
Support engineering teams on equipment selection, qualification, and start up activities.
Establish CPV program for process performance
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.
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 Technical Development to successfully transfer Drug Product processes including final formulation, parenteral vials and lyophilized products.
Lead investigations and resolve complex manufacturing issues.
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 Education/Experience:
BA/BS or higher in science, biochemistry, biotechnology, biology, chemical engineering and/or related discipline.
Expert level knowledge in Drug Product aseptic filling operation including, isolators, lyophilizers, and automated inspection.
Expertise in late stage/commercial biopharmaceutical Drug Product technology transfer, process characterization and process validation.
Experience leading execution of PPQ activities, including authoring protocols and reports.
Leading investigations and CAPA for major deviations.
Experience with CPV and lifecycle process improvements.
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.
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
Professional Experience
Minimum of 8+ 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.
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.
This role in the Manufacturing Science and Technology (MST) department supports BeOne's Drug Product Manufacturing site in New Jersey (Hopewell). This role will lead the site drug product MST function to support technology transfer, validation, continued process verification, investigations, change management and manufacturing startup. Reporting to the MST leadership, this role is responsible for managing the technical operations supporting both clinical and commercial manufacturing activities.
Essential Functions:
Serve as MST DP Subject Matter Expert (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 related activities
Support engineering teams on equipment selection, qualification, and start up activities.
Establish CPV program for process performance
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.
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 Technical Development to successfully transfer Drug Product processes including final formulation, parenteral vials and lyophilized products.
Lead investigations and resolve complex manufacturing issues.
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 Education/Experience:
BA/BS or higher in science, biochemistry, biotechnology, biology, chemical engineering and/or related discipline.
Expert level knowledge in Drug Product aseptic filling operation including, isolators, lyophilizers, and automated inspection.
Expertise in late stage/commercial biopharmaceutical Drug Product technology transfer, process characterization and process validation.
Experience leading execution of PPQ activities, including authoring protocols and reports.
Leading investigations and CAPA for major deviations.
Experience with CPV and lifecycle process improvements.
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.
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
Professional Experience
Minimum of 8+ 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.
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.