Head of Drug Product Operations
Today, 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.
Lonza is establishing a strategic biomanufacturing base in China using GE Healthcare Solutions. With the new facility, Lonza is responding to growing demand for a high-quality CDMO in the Chinese market. The two companies will work closely on the design of the 17,000 m2 site, which will include 6,500 m2 of lab space and one KUBio facility. With more than 20 successful FDA approvals for biologics, combined with international regulatory expertise, Lonza will now be able to offer the same high standards in China as it does elsewhere. Lonza plans to hire and train a significant number of staff for this site. This role will deliver on the project business case to develop LPB Biologics business in China by leading all of its related commercial & go-to-market activities.
- Managing the Drug Product manufacturing unit and giving leadership to the multi-disciplinary operations team (Manufacturing, process experts, MSAT) of senior production leaders, managers, supervisors and operators. Full responsibility for all aspects of human resource management such as qualification, development, coaching, hiring, pay decisions and discipline issues.
- Build up and sustain a successful, high performing team. Maintain a culture of empowerment and innovation, trust, high performance and change readiness.
- Responsible for resource and vacation planning of the assigned team members with regard to the fulfillment of all production orders.
- Ensures a good information exchange from the upper management levels) to the organization and the other way around through regularly team meetings and escalation of production issues.
- Implements the LONZA culture via openness for change and new ideas, cooperative teamwork and continuous improvement even outside the own area of responsibility.
- Working as operations lead in the Capital investment project for building and commissioning of the manufacturing unit.
- As end user main driver for the operational set-up and other factors influencing the manufacturing costs. Shares experience from an operational and maintenance point of view with the design team.
- Responsible for operative takeover of the new plant (after operational qualification, before performance qualification) and integration in the overall manufacturing network of Lonza and the Ibex site.
- Accountable for preparation of risk analysis (SHE, GMP) and all relevant procedures and ensuring training of staff.
- Planning & Supervision of production activities to ensure products are manufactured and delivered safely, timely, cost effective with the required quality.
- Responsible for operative aspects of the DP facility and integration in the overall manufacturing network of Lonza, Ibex and Drug Product Services.
- Ensuring the technical availability of the plant also with respect to regulatory requirements (Safety, cGMP)
- Responsible for developing continuous improvement programs to reduce cost and increase productivity through Operational Excellence and Innovation initiatives
- Developing department goals and strategy and prioritize with respect to overall goals of Lonza, the Lonza BU and the Ibex site.
- Responsible for preparing the budget of the unit and preparing lumpsums, CARs and upon approval ensuring their execution accordingly to plan and budget.
- Ensuring proper execution of all people management activities including training, development and retention of associates according to the needs of the production unit.
- Representing the facility during regulatory inspections and customer audits as Operations Head
- Serving as an integral member of the Ibex Leadership Team (SLT) responsible for all aspects representing the Drug Product facility.
- Ensures and manages the interfaces between Manufacturing, MSAT, Plant Engineering, Support, QA, QC and Drug Product Services.
- Responsible for control of own cost center, identifies and implements cost reduction measures
- Represents facility during inspections and audits as SME for area of responsibility.
- Bachelor degree ( prefers PhD or MSc) in pharmaceutical sciences, chemistry, or process engineering, or related fields or equivalent with significant work experience in sterile Drug Product manufacturing.
- Experts in industry experience in aseptic product manufactures (clinical product and/or commercial product) with proven knowledge of cGMP compliance requirements.
- Prior experience in the design and building and ramp-up of a Drug Product Sterile Facility (aseptic).
- Profound knowledge of aseptic processing and GMPs. Depth understanding of operational excellence to solve problems; very good understanding of business and financial processes
- Demonstrates effective leadership. Ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders.
- Must be capable of motivating others, creating a positive work climate where inter-departmental collaboration, coaching and performance feedback are continuous.
- Experienced at establishing clear directions, leading others and bringing out their best.
- Excellent organizational and planning abilities. Must be able to break down complex problems and tasks into activities capable of being performed by personnel. Demonstrate sound decision making, considering broad scope of factors.
- Ability to effectively prioritize and direct tasks in a fast-paced environment is critical.
- Strong written and verbal communication skills.
- Ability to work inter-departmentally and with customers.
- Good command of English and proven IT knowledge
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.