Senior Manager, Process Engineering Drug Substance and Drug Product
About The Position
BeOne Medicines is seeking a highly motivated and organized Senior Manager of Process Engineering for Dug Substance and Drug Product to join our team at the Hopewell, NJ site. The successful candidate will be responsible for leading a hands-on team of subject matter experts focused on supporting technology transfers and new equipment selections, troubleshooting and supporting day-to-day manufacturing, supporting deviation/investigation root cause analysis, regulatory inspections, and continuous improvement. This role works independently, with minimal supervision and direction and will provide technical direction, Project Management support.
Requirements
- Minimum 7 years of experience GMP pharmaceutical operations support. in biopharmaceutical manufacturing, engineering, and/or project management and at least 5 years of project management experience in biologics or GMP.
- Effective leadership of technical teams.
- Passion and expertise developing a team of Engineers
- Effectively gives and receives feedback.
- Proactively identifies, shares, and implements improvement opportunities that supports the site.
- Proven ability to manage multiple complex priorities simultaneously under tight timelines.
- Analytical problem-solving skills and proactive decision-making.
Nice To Haves
- OE and/or LEAN Methodologies
- Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word, Outlook).
- Experience with project management tools such as Microsoft Project, Autocad, Smartsheet.
- Familiarity with data management and visualization tools (e.g., SharePoint, Teams, Power BI).
- Ability to create and maintain Gantt charts, dashboards, and tracking templates.
- Comfortable working within document management systems (e.g., Veeva Vault, eQMS, or similar).
Responsibilities
- Effective leadership of technical teams with focus on right-first time Quality.
- Prior hands-on experience in the design, selection, and troubleshooting of systems and equipment used in commercial Drug Substance and Drug Product manufacturing.
- Support of technology transfer and qualification studies associated with the development and implementation of processes, systems, and facilities related to drug product manufacturing.
- Partner with Operations, Quality, and Automation functional areas.
- Develop and review technical documentation
- Participate and lead in controls fault analysis and remediation
- Directly support operations with troubleshooting and issue resolution
- Requires working in an industrial manufacturing environment including gowning
- Support operations and ensure compliance with regulatory, corporate and site requirements
Benefits
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
- Discretionary equity awards
- Employee Stock Purchase Plan
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What This Job Offers
Job Type
Full-time
Career Level
Senior
