Johnson & Johnson Careers
Director Pharmaceutical Development Pilot Plant
Requisition ID: 1805686312W
Clinical Supply Chain (CSC) is part of the global Janssen Research & Development organization within Johnson & Johnson.
The organization is responsible for clinicial supply design, planning, make and delivery of supplies to all clinical trials of J&J.
As part of the CSC organization, we are seeking for an experienced and enthusiastic leader to lead the Pharmaceutical Development Pilot Plant (Farmaceutische Produktontwikkeling – FPO), based in Beerse, Belgium:
Head, Pharmaceutical Development Pilot Plant, Beerse, Belgium
The head is responsible for the pilot plant and clinical manufacturing operations, according to preset objectives on compliance, cost, time, and service. Activities include oral solid dosage production, both via batch and continuous manufacturing processes, oral liquid production as well as sterile fill finish for both large and small molecules. In addition, the plant may serve as a commercial launch facility. As the Head of the pilot plant, you play a critical role in the future development of a competitive organization that is recognized by our customers as a partner of choice in terms of reliability, quality, safety, flexibility and innovation.
The Head will carry final responsibility for the Pilot Plant and Clinical Manufacturing Operations. More specifically, he/she will be responsible for:
- Timely and reliable delivery of clinical drug product material to clinical Pack & Label.
- Ensuring full compliance (SOP’s, qualification status, training records, validation master plan,…) in close partnership with the quality organization, as well as safety of all operations.
- Ensuring inspection readiness at all times, and acts as a spokesperson during audits and general GMP inspections
- Ensuring proper maintenance, validation/qualification status of pilot plant equipment and facilities.
- Management of pilot plant operational budget and capex.
- The development and implementation of site master plan for the pilot plant, in close collaboration with drug product development.
- Development and coaching of staff to further increase their technical and compliance expertise, people management skills, and maintenance of training records.
- Benchmarking and shared learning with other plants within the network as well as externally, including the follow-up and influencing of regulatory guidelines.
- In collaboration with other departments, further define and drive an implementation strategy for pilot plant-related systems.
- Further strengthen the partnership with other departments, both within CSC as well as other areas (e.g. Drug Product Development, Janssen Supply Chain).
He/she reports to the global Head of Drug Product and Clinical Pack & Label, CSC.
- You have a Ph. D or a technical Master's degree in chemical or biological engineering, pharmaceutical sciences or equivalent.
- You have at least 10 to 15 years of relevant experience in an operational pharmaceutical development and manufacturing environment, including direct experience in drug product clinical manufacturing operations.
- You have a strong mindset for safety, reliability and quality. You have strong knowledge and understanding of compliance & cGMP legislation/guidelines applicable to the pharmaceutical industry for sterile and non-sterile manufacturing. You have experience with regulatory inspections.
- You are a strong leader, able to influence and shape an organization towards a clear common goal and vision, with a passion for development of people and teams.
- Insight in financial management and budgeting.
- Fluency in spoken and written English is required; given the significant component of change management mother tongue/Advanced in Dutch preferred. Candidates not speaking the local language will be expected to participate in language immersion programs
- You are an active, committed and decisive leader. You operate in a result-oriented manner, act directly but with the necessary empathy to make your team stronger.
- You are able to make appropriate, risk-based decisions.
- You are a strong communicator, capable of working with stakeholders and customers to ensure the pilot plant delivers upon commonly determined expectations.
- You are enthusiastic, you are driven, you can drive change and continuous improvement.
Janssen Pharmaceutica N.V. (7555)
R&D Engineering (R&D)