Johnson & Johnson Careers
Principal or Senior scientist - Technical Launch Integrator
Requisition ID: 1905717712W
“Caring for the world … one person at a time” inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that is anchored in the internationally applicable Credo. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 260 operating companies in more than 60 countries employing approximately 134,000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.
Technical Operations, being part of the
Janssen Supply Chain and a member of Johnson & Johnson Family of companies,
is currently looking for a
Senior or Principal scientist –
Technical Launch Integrator
in the Parenterals Platform to be based in Europe (Schaffhausen or Beerse) with up to 30% travel.
The Technical Launch Integrator (TLI) provides technical drug product support and has overall accountability for ensuring fit for plant and commercial readiness during technical development and execution of the transfer of pharmaceutical processes and products into the supply chain and the global market place. Areas of key responsibility include Drug Product (DP) technical support and oversight for the supply chain, planning and execution of manufacturing site activities from transfer through commercial production, and DP manufacturing site level support of new product launch. To fulfill his role the TLI is a member of several cross functional teams.
In addition to the TLI role, this position may also support marketed products, as Drug Product Technical Owner (DPTO). The DPTO is the voice of Technical Operations in the Value Stream team and responsible for the technical aspect of the holistic Lifecycle Management structure and strategy of drug product (for small and large molecules and both for new and legacy products).
PRINCIPAL RESPONSIBILITIES - TLI:
- Technical and manufacturing integration of new and re-developed drug products from R&D into the supply chain (large and small molecule).
- Leading the DP manufacturing site team and manufacturing site representative on the PDMS DPD Subteam and the JSC New Product Team.
- Single point of contact for Janssen Supply Chain (JSC) plant readiness and execution from technical transfer into commercial production (e.g. tech transfer implementation, site based documentation, planning, risk management, budget) including launch support.
- JSC technical input and technical acceptance of DP into the supply chain including cost and robustness metrics through a process of “touch points”, thereby ensuring “one voice of the customer” towards R&D and consistency across projects and across plants.
- Contribution, review and approval of drug product technical and regulatory documents (e.g., protocols, reports, filings, criticality analysis, control strategies, master plans, etc), routine technical support during execution, integration of JSC technical expertise (e.g., platforms, engineering, SME’s) into project execution and QbD technical implementation at the manufacturing site level.
PRINCIPAL RESPONSIBILITIES - DPTO:
- Represents Technical Operations and the technical team in the value stream team, owns the coordination of all product related technical activities and participates in development of long term supply strategy including scenario development and E2E impact analysis.
- Collaborates with R&D, site functions and finance to identify COGS improvement opportunities (COGS optimization process).
- Monitors technical process and product performance and supports failure investigations (escalation of quality or compliance events).
- Executes or follows-up on execution of technical projects.
- Understands the technical aspect of the lifecycle strategy of products.
- Manages a multi-disciplinary team of technical experts in the following areas: manufacturing site representatives, R&D, product stability, regulatory, QA and Q&C.
- Monitors technical process and product performance across internal and external Manufacturing sites.
- Requirements: you have a University/master’s Degree in engineering, Chemistry or Pharmacy or related area, as a minimum with 5 to 8 years of experience in pharmaceutical development or pharmaceutical manufacturing or related post graduate academic experience/education.
- Experience in Parenteral Manufacturing processing requirements/techniques, especially in the field of Aseptic processing, Formulation, Fill-Finish and packaging.
- Experience with introduction of pharmaceutical products to manufacturing sites and late state development with working technical knowledge of manufacturing site unit operations.
- Planning and logistics skills capable of effective integration of DP deliverables and support detailed execution at the manufacturing site level.
- Knowledge of manufacturing site systems and procedures (SAP, vent and complaint handling, change control, qualification, process validation and Continued Process Verification, … etc.)
- Good knowledge of EHS, Q&C, and regulatory requirements/GMP.
- Demonstrated leadership in providing integration of activities and information across multifunctional groups and matrix teams.
- Project management skills (FPX or similar), project planning, structuring, organizing, coordinating teams, and setting up and maintaining communication with stakeholders and wider network organization;
- Excellent written and oral communication skills and ability to influence peers, superiors, and partners.
- Motivated, self-starter able to work independently with demonstrated problem solving skills
- Proficiency in English (spoken and written) is a requirement, knowledge of German language is an added value.
We are offering you a multifaceted challenge in a dynamic, international environment with attractive terms and career opportunities as well as a good infrastructure.
If you are interested in this position, then please apply online including application letter, CV and ideally testimonials.
Cilag GmbH International (8525)