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Technical Operations Site Lead
Requisition ID: 2458180201
Johnson & Johnson's Family of Companies is recruiting for a Technical Operations Site Lead (Manager level 1) to be located in Malvern, PA
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information. We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
- The TO Site Lead manages a Technical Operations (TO) team with focus on execution of Product Transfer /Product Introduction for the Site, Process and cleaning validation, process improvements in support of technology and product technical life cycle management and deployment of standards.
- The TO manager will report dotted line to the site General Manager and solid line to the TO Parenteral Platform Lead.
- The TO manager and team are accountable for the Validation Masterplan and execution of related Performance qualification, and Process as well as Cleaning Validation.
- System Owner of Validation and PQ and therefore accountable for Regulatory Inspection for area of responsibility. This includes technical support in partnership with Quality on any regulatory audits and inspections and being the Spokesperson in Audits internal and external.
- Partnering with Engineering and Production on Project Oversight of project assigned as well as day to day investigations, escalations. Partnering with Product Stream Lead, site GM and BUs on project priorities.
- Accountable for managing team in accordance to Site and Technical Operations priorities following the JSC Business Cascade (Budgeting, Resources)
- Monitoring and continuous improvement of Site Technical Operations KPIs.
- Motivates and inspires site team to drive significantly increased performance through technical innovation and change. Provides leadership and development to the team and ensures there is a diverse pipeline of high performing multi-skilled leaders of the future. Ensures development opportunities. Evaluates performance and provides feedback. Implements disciplinary actions, as necessary.
- Support and lead as needed Product Transfer /Product Introduction and/or technical product life cycle management projects. Monitor technical process and product performance. Lead or support complex failure investigations (escalation of quality or compliance events)
- Minimum of a Bachelor’s degree in Engineering , Biotechnology, Chemistry or related area required with a Minimum of 8 years of experience in a highly regulated environment
- Strong expertise in pharmaceutical manufacturing processes and products
- Experience with the respective Platform Technology, i.e. Biotechnology - Large Molecule upstream and downstream processing
- Project management experience and/or (FPX) training
- Process excellence (6sigma), lean concepts and tools
- Strong knowledge of Quality & Compliance / regulatory requirements (GMP/EH&S) especially for Technology Platform
- Working knowledge of financials (budgeting & costing)
- Ability to lead cross functional team
- Ability to manage complexity and change
- Ability to interact at different levels of the organization
- People leadership experience
- This position is located in Malvern, PA and will require up to 10% domestic and international travel
Janssen Biotech, Inc. (6014)