Johnson & Johnson Careers
Business Unit Lead, Technical Operations (Athens)
Requisition ID: 3239190501
Janssen Supply Chain (JSC) is recruiting for a Lead Technical Operations (TO), for one of our Business Unit (BU) that manufactures Small Molecule Active Pharmaceutical Ingredients (SM API) located in Athens, Georgia (USA).
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 lead coordinates process engineering resources in support of new product launches, life cycle management strategies, technical transfers, new process technologies, cleaning validations and overall performance tracking. This position contributes to the global API SM TO strategies and the financial performance of the business unit. The lead is a team member of both the local business unit and the global TO leadership teams. The key responsibilities are as follows:
- Lead a team of engineers taking ownership for new product introductions, Life Cycle Management support and optimization of launch and growth products.
- Deliver the technical operations service to meet the business unit goals.
- Works together with the other TO leads to drive commonalities, share knowledge as to deliver value through enhanced collaboration.
- Translate the global TO and SM platform strategy into G&O’s for local team.
- Take accountability as a SPOC (single point of contact) for all TO activities within the BU.
- Take accountability for Process and Cleaning validation within the Business Unit in close collaboration with the global TO Subject Matter Experts.
- Works with the global technology development function to design specific technology solutions for optimized synthesis processes.
- Works globally to develop and implement data analytical tools.
- Create a dynamic and empowered team, strong in cross functional collaboration and assuring flexibility across BU’s.
- Creates a “One Plant” mindset and culture to strengthen the overall value of clustering the business units.
Manage Product Transfer /Product Introduction
- Define the project Scope and Objectives in close collaboration with Technical Launch Integrator
- Perform the Technical Assessment and Fit to Plant exercises
- Develop Project Strategy/Plan
- Develop the team and define Interfaces with Technical Operations Global Functions, Quality Assurance, DPDS, MAM and Operations
- Process Transfer and documentation
Provide engineering support during product life cycle
- Partner with Global Value Chain Lead and BUs on project priorities.
- Partner with Production on Project Oversight of projects assigned as well as day to day support (e.g. investigations, escalations).
- Monitor process and product performance, based on Continuous Process Verification (CPV)
- Lead or support complex process investigations (escalation of quality or compliance events)
Innovation & Standardization (Evaluate new technologies such as PAT; Contribute to Standardization initiatives for Technical Operations).
- Support introduction of new process technologies
- Implement Process optimizations and CIP’s from improved data analytics
Prepare Health Authority Inspections
- Technical support in partnership with Quality on any regulatory audits and inspections
- Being the Spokesperson in Audits internal and external for the TO processes
- The TO manager can also take the role of a API Technical Owner for a given synthesis or manage API Technical Owners in her/his team
- A Bachelor’s degree in chemical engineering or related field is required. A Master’s degree is preferred.
- A Minimum of 10 years of experience in a pharmaceutical manufacturing environment is required
- Strong people leader with previous experience in leading teams is preferred
- Strong expertise in Small Molecule API business is required
- Strong experience in chemical manufacturing processes, technologies and products is required
- Project management, organizing, planning and coordination skills is required
- Process excellence, lean production concepts and tools is preferred
- Strong mind-set and knowledge of Quality & Compliance / regulatory requirements (GMP/EH&S) is required
- Strong Business acumen and understanding of financials is preferred
- Ability to aim for innovation and change to ensure competitiveness is preferred
- Ability to lead and inspire cross functional teams is required
- Strong interpersonal skills (influencing, negotiating, handling conflicting interests) are required
- Able to make decisions autonomously is required
- Comprehensive knowledge of end-to-end supply chain is required
- Demonstrated ability to build and maintain a diverse leadership team and champion an inclusive culture to realize the SM TO Vision and mission throughout the organization is required
- Ability to influence peers and people at higher levels within the organization is required
- Affinity with data mining tools is preferred
- This position will be located in Athens, GA and may require up to 10% domestic and international travel
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 Pharmaceuticals, Inc (6062)