Director, Technical Site Lead – Leiden
Janssen Supply Chain (JSC) is recruiting for a Director, Technical Operations Site Lead – Leiden, who has the responsibility for the management of the Site Technical Operations department in Leiden.
The Technical Operations Director manages a Technical Operations (TO) Team with the dedicated focus on:
1. NPI / LCM - Technology transfer coordination at site
2. PQ, validation execution (Process and Cleaning Validation)
3. Process improvements execution
4. Standards deployment, PAT, technology
The Technical Operations Director will report solid line to the TO LM Platform Lead and dotted line to the Site General Manager. The Site Technical Operations Lead leads a team of Scientists and Engineers (Cleaning and Process Validation Experts and Project Managers) across the Site Business Units in span of control of the site.
Being accountable for the Validation Masterplan and execution of related Performance Qualification, Life Cycle Management Process as well as Cleaning Validation. Being System Owner of Validation and PQ and therefore accountable for Regulatory Inspection for area of responsibility.
The Technical Operations Director/ is responsible for day-to-day PQ & Validation Management as well as related Project Execution, including supporting NPI or Life Cycle Management initiatives. The Technical Operations Director is responsible for the execution of standards and delivery of business results on site.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Supply Chain, LLC, is part of the Janssen Pharmaceutical Companies.
- The TO Site Lead manages a Technical Operations (TO) team with focus on execution of Product Transfer /Product Introduction for the Site, Life Cycle Management Process and cleaning validation, process improvements in support of technology and product technical life cycle management and deployment of standards.
- The TO Site Lead will report dotted line to the site General Manager and solid line to the TO LM Platform Lead.
- The TO Site Lead and his/her 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 MAM and Production on Project Oversight of project assigned as well as day to day investigations and escalations. Lead or support complex failure investigations (escalation of quality or compliance events).
- Partnering with Product Stream Leads and other TO platforms and COEs, site GM and BUs on project priorities.
- Monitor technical process and product performance
- Monitoring and continuous improvement of Site Technical Operations KPIs.
- Accountable for managing team in accordance to Site and Technical Operations priorities following the JSC Business Cascade (Budgeting, Resources)
- Motivates and inspires site TO 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.
- Drives a Credo-based culture.
- Handles all aspects of managing personnel, including hiring and terminations. Provides coaching and development opportunities. Evaluates performance and provides feedback. Implements disciplinary actions, as necessary.
- A Bachelor’s degree (or University Equivalent) Chemistry, Pharmaceuticals, Engineering, or related area is required. An advanced degree is preferred.
- A Minimum of 10 years of experience in Drug Substance pharmaceutical development or pharmaceutical manufacturing or related post graduate academic experience/education is required.
- Knowledge of both Pharmaceutical Manufacturing and Technical Operations functions and experience with Large molecules and/or Parenterals is preferred.
- Demonstrated leadership in providing integration of activities and information across multifunctional groups and matrix teams is preferred.
- Ability to foster team productivity and cohesiveness and to work collaboratively to execute, deliver and get results through the various matrix teams is preferred.
- Excellent written and oral communication skills and ability to influence peers, superiors, and partners is required.
Languages: Fluent in written and spoken English, Basic understanding of Dutch is required (written and spoken).
- Motivated, self starter able to work independently with demonstrated problem solving skills is required
- The role is based in Leiden and will require up to 10% international travel.
We are offering you a multifaceted challenge in a dynamic, international environment with attractive terms and an excellent infrastructure.
If you feel attracted by this challenge and want to be part of a successful and growing organization, then please send us your online application (CV).
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Janssen Biologics (7266)