Technical Support Manager
il y a 1 semaine
Company Information
Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Role Overview
The Technical Support Manager will be
part of the MS&T team and will be responsible to:
- Partner closely with Quality, Compliance, Operations and technical experts to drive accelerated, robust and consistent resolution and escalation of process issues as applicable while ensuring batch quality and adherence to procedures and instructions.
- Advise on manufacturing investigations and CAPAs as well as review protocols and batch records to ensure alignment with the manufacturing process.
- Oversee the evaluation of process changes arising from updates to materials, excipients or finished goods requirements and ensure seamless transition of process changes from clinical to commercial operations. Point of contact with equipment suppliers for timely and continuous support.
- Lead regular Kaizen events and resulting actions identified to continuously reevaluate the manufacturing process and process execution to identify opportunities for improvement and waste reduction.
- Own the troubleshooting process executed by the MFG technical specialists.
- Coaching, mentoring and further developing the MFG technical specialist team.
- Ability to accommodate changes in the schedule including working on shift / being on call as necessary to support operational needs.
Major Responsibilities:
The Technical Support Manager reports to the Process Engineering Lead and is responsible for:
Process Robustness- Be the first point of contact to provide
support, scientific and technical expertise in the Technical Operations group during issue on the shop floor - Input into the drafting and improving Manufacturing Batch records and related documentation up to date.
- Build knowledge/expertise within the Technical Operations group on the process and the equipment to aid with troubleshooting and resolve complex scientific/technical problems.
- Technical and advisory support for tech transfers, process improvements and changes and support implementation of changes Support with the implementation of process changes.
- Build troubleshooting guide and keep up to date based on observed issues on the floor
- Oversee the technical specialist team and ensure safe and compliant manufacturing troubleshooting according to cGMP requirements
- Oversee the hiring, development and performance management of staff and assign personnel to execute the daily schedule
- Establish key stakeholder relationships, both internally and externally. Ability to interact with all levels within the organization
Quality & Compliance
- Serve as a lead and Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits.
- Support manufacturing investigations, support and manage change controls, and maintain permanent inspection readiness and actively support regulatory inspections.
- Provide technical/scientific assessment, recommendations and support to cGMP documentation: Change Controls, deviations and CAPAs
- Provide scientific expertise to help identify true root cause of investigations and assess product quality impact.
Tech Transfer, Continuous Improvement
,
Operational Excellence
- Lead smaller opportunities for process improvements related to safety, environmental, quality, compliance, productivity, yield, and cost, and drive implementation aligned with the change control strategy.
- Partner with all relevant teams and/or external vendors to support implementing process improvements. Work with vendors to evaluate new raw materials and consumables for compatibility with the Manufacturing process.
- Technical and advisory support for tech transfers, process improvements
Qualification
Education:
A minimum of a Masters degree in engineering or related field or equivalent experience required. Advanced degree preferred.
Experience:
5+ years of operations experience within a cGMP environment in the biotech/biopharma industry and Cell/Gene Therapy cGMP manufacturing experience preferred 2 years of experience in management of a team
Capabilities, Knowledge, and skills:
- Prioritize and manage multiple tasks simultaneously. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment
- Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
- Excellent teamwork and interpersonal skills with the ability to influence and build strong working relationships at all levels
- Responsiveness of issues and able to take decisions under time pressure
- Effectively communicate with people at all le
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