· Managing the Drug Product manufacturing unit and giving leadership to the multi-disciplinary operations team
(Manufacturing, process experts, MSAT) of 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 facility and integration in the overall manufacturing network of Lonza
and the Guangzhou site.
· Accountable for preparation of risk analysis (EHS, 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.
· Ensuring the technical availability of the facility 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
Guangzhou site.
· Responsible for preparing the budget of the unit and preparing lump sums, CARs and upon approval ensuring their
execution accordingly to plan and budget.
· Ensuring proper execution of all people management activities including hiring, training, development and retention of associates according to the needs of the production unit.
· Representing the facility during regulatory inspections and customer audits as function Head.
· Serving as an integral member of the Guangzhou Leadership Team (SLT) responsible for all aspects representing the Drug Product facility.
· Ensures and manages the interfaces between Manufacturing, MSAT, site Engineering, QA and QC.
· 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.
Qualifications/Skills
1.Education
University degree (PhD or MSc) in pharmaceutical sciences, chemistry, or process engineering, or related fields or
equivalent with significant work experience in sterile DP manufacturing.
2.Experience
More than 10 years' 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 DP Sterile Facility (aseptic).
International experience and experience in large pharma is strongly Requested.
3.Licenses or Certifications
Green or Black Belt is preferable.
4.Knowledge
Profound knowledge of aseptic processing and GMPs. Depth understanding of operational excellence to solve problems; very good understanding of business and financial processes.
5.Skills
· 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 both of English and Chinese.
· Proven IT knowledge.
6.Qualities & Attitude
Structured, focused and well-organized working attitude; open-minded for new ideas and solution-oriented;
high motivation and dynamic drive; action orientated.