Associate Director, Drug Product, Manufacturing Sciences and Technology

Role Summary

Associate Director, Drug Product, Manufacturing Sciences and Technology. Lead the site drug product MST function to support technology transfer, validation, continued process verification, investigations, change management and manufacturing startup. Manage the technical operations supporting both clinical and commercial manufacturing activities at BeOne’s Drug Product Manufacturing site in New Jersey (Hopewell).

Responsibilities

• 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. Align with other global manufacturing sites through shared knowledge, data, issues, and 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 stakeholder alignment. Assist in regulatory filings and Health Authority site inspections to license and maintain BeOne‚Äôs pipeline and product portfolio.

Qualifications

• Required: BA/BS or higher in science, biochemistry, biotechnology, biology, chemical engineering or related discipline.
• Required: Expert knowledge in Drug Product aseptic filling operations including isolators, lyophilizers, and automated inspection.
• Required: Expertise in late stage/commercial biopharmaceutical Drug Product technology transfer, process characterization and process validation.
• Required: Experience leading execution of PPQ activities, including authoring protocols and reports.
• Required: Leading investigations and CAPA for major deviations.
• Required: Experience with CPV and lifecycle process improvements.
• Required: Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing.
• Required: Ability to work independently and as part of a team; able to function in a fast-paced dynamic environment and balance multiple projects.
• Required: Excellent troubleshooting skills; ability to compile, analyze and interpret data; ability to write routine reports and correspondence.
• Required: Strong interpersonal and communication skills, verbal and written; ability to speak effectively before groups of customers; ability to communicate in a dynamic environment.

Skills

• 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

Experience

• Minimum of 8+ years of experience working in Biopharmaceutical DP process development or manufacturing.

Education

• BA/BS or higher in science or related discipline.

Additional Requirements

• Must be able to stand for long periods, up to 8 to 10 hours/day; capable of lifting up to 40 lbs; work on-site at least 40 hours/week; capable of working in varying temperatures; may require gowning depending on area; work with hazardous materials and chemicals.
• Health authority inspections experience (FDA, EMA, ICH) and execution/optimization of controlled procedures; strong technical and business writing; experience with business process development.
• Travel: International and domestic ‚Äì periodically.