Lonza Drug Product Manager – Biotechnology & Biology Apply
Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Job Title: Manager, Drug Product and Materials
Location: United States, Lexington (Massachusetts)
- Preferred to have several years prior experience within Life Science/biotech/pharmaceuticals industry, preferably with a focus on manufacturing operations.
- AS/BS in Biotechnology, Biology, Chemistry, or related STEM field is preferred. High School Diploma or GED can be considered with relevant and satisfactory professional experience in pharmaceutical/biotech/life science manufacturing.
- Preferred to have 3+ years of experience in supervisory or managerial roles in life science/biotech/pharmaceutical industry.
The Manager will provide a safe, controlled work environment in all areas of responsibility. Be aware of the site safety objectives and make sure they are communicated and understood by all staff. She/He will act as the Subject Matter Expert in the assigned area (i.e. DP formulation, Vial filling and sealing, and vial inspection during manufacturing operations until the manufacturing staff is fully proficient.
- The Manager will provide off-suite and in-suite oversight of the manufacturing process during critical operations (i.e Drug Product (DP) formulation, chromatography, and sterile filtration, vial filling/sealing, etc.) and will perform on floor work depending on shift staffing levels.
- Responsible to ensure the timely availability of materials to support the Supply Plan for Lonza Lexington for both Drug Substance and Drug Product Manufacturing.
- Responsible to liaise with all key functions to ensure timely updates to material plans considering changes to plans or material availability issues
- Execution of key tasks to support inventory plans and optimization initiatives
- Support all tech transfers/work with the Internal and Joint Project Teams to transfer customer processes into the production facility. Attend the IPT and JPT meetings as required during campaign preparation and the post-campaign lessons learned events. Define and own “improvement” actions for manufacturing.
- Own and manage planned deviations and change controls related to exosome DP Manufacturing and Materials staff. Provide/Arrange effective trainings for manufacturing staff related to any new equipment or systems to be used in exosome manufacturing.
- Collaborate with Supply Chain, MSAT, Engineering and Quality Assurance personnel
- Drive Manufacturing Readiness at Lonza Lexington to include:Represent site in the implementation of SAP at Lonza Lexington
- Coordinate/collaborate with network resources on material buying/planning
- Collaborate with MSAT, Engineering, Materials and QA/QC in drafting and approving manufacturing procedures e.g. SOPs and batch records
- Support building & establishing the manufacturing team.
- Support MSAT and materials management on BOM definition and material specification and procurement activities
- Support the development and execution of appropriate Safety, Training, Gowning, Material, Cleaning, Scheduling, Financial Management and EM strategies.
- Execution of all process-related activities in compliance with EHS and GMP requirements.
- Oversee/Ensure On Time and Compliant Execution of All Production-related
- Work with Manufacturing personnel to ensure compliant execution of low deviation manufacturing runs
- Work with Manufacturing personnel to ensure batch record entries and data are accurate and recorded real time
- Implement and lead daily shift coordination meetings to ensure the plan is set and clear to all team members
- Support Quality in lot release activities e.g. deviations, CAPA’s, batch record review and discrepancy resolution
- Oversee Material planning to ensure On Time material delivery and release Activities
- Perform all routine tasks to convert planned orders into material plans including the creation and management of material planned requirements
- Liaison with Supply Planner and Schedulers to ensure all material plans are up to date and responsive to changes in material requirements
- Creation and maintenance of detailed material planning parameters in Planning systems
- Conversion of the material requirements plan (purchase requisitions) into Purchase Orders
- Expediting material availability through liaison with procurement and teams involved with inbound material processing
- Creation and management of material related KPIs and measures to ensure accurate understanding of material availability
- Execution of key material availability, mobilization or write actions to support optimal management of inventory while reducing scrap/waste
- Liase with key stakeholders (Supply Planner, Scheduler and PM) to develop safety stock and inventory plans to meet production plans
- Track, report and facilitate on-time material availability including testing and release for production
Lonza Drug Product Manager