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Engineering

Technical Launch Integrator

  • Título Technical Launch Integrator
  • Función Engineering
  • Sub función Process Engineering
  • Ubicación Leiden, South Holland, Netherlands
  • Publicado
  • Identificación requerida (Req ID) 2206090645W
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Descripción

POSITION SUMMARY

This role is responsible to lead the coordination of technical services activities across the large molecule platform. In this role the incumbent is charged with managing New Product Introduction and Life-Cycle Management projects that must drive reliability and sustainability of our Parenteral bulk drug substance manufacturing plants and products. This person will provide the overall project portfolio management and leadership role to lead and facilitate the activities related to all technical support related to establishing standardized Design-to-Value strategies in the Janssen's Biologics Drug Substance Supply Chain network, for both internal and external manufacturing facilities. This role will partner with R&D, Quality, and Regulatory to ensure processes are flawlessly introduced into and managed through the supply chain network and that models are developed and utilized to ensure both new and ongoing production consistently satisfies quality and regulatory needs. The incumbent must be able to work independently to drive and execute projects of a complex nature where analysis of situations or data requires an in depth evaluation of various identifiable factors in multifunctional areas, and must have strong communication skills to influence other functions/levels outside of own group and effectively leads cross functional and cross organizational teams to generally attain expected results for all parties. Strong knowledge in biologics bulk drug substance manufacturing processes and regulatory filing experience is a must. Hands-on experience in both R&D and Manufacturing Operation is highly desirable.

PRINCIPAL RESPONSIBILITIES:  

Represent Global Technical Operations and partner with operation, R&D, regulatory and quality to develop and implement a strategy for standard manufacturing practice, new product introduction and marketed product support across large molecule product portfolio. Responsible to assure ensure manufacturing site readiness, reliability and sustainability.

Accountable technical lead for identifying new technology or areas of improvements on current and future processes, capital utilization, cost of goods optimization, and advanced expertise on feasibility and risks management.

Strengthen external network of academic, regulatory, professional and cross company alliances to enhance standardization of current approaches and introduction of new technologies across platforms and industry.

Oversee Process validation, FDA filing activities.

Coordinates and executes product introduction at the site from drug substance (OS) transfer through launch covering raw materials and process integration. Supports the New Product Launch teams for site related launch activities.

Delivers clinical through commercial Drug Substance supply from the manufacturing site ensuring manufacturing performance, cost, and robustness requirements are met.

Provides required manufacturing technical support, documented technical input, review, and approval and serves as the JSC

technical expert. Represents JSC in all Design-for-Manufacturability (DfM) activities during the development process.

Responsible for delivering a Drug Substance process capable of meeting the Gross Profitability targets together R&D, Finance and Operation, and conduct Cost-of-Goods (COGS) sensitivity assessments.

Calificaciones

KNOWLEDGE SKILL AND ABILITY REQUIREMENTS:  Describe the minimum knowledge, skill and ability requirements for the position.  Include any degrees or certifications which are required and/or desirable .

COMPETENCY (knowledge, skills, abilities and experience required):

1. Specific knowledge

  • Proven track record in large molecule process development, new product introduction and ongoing production support of large molecule pharmaceutical products. Had accountability and success for design, start-up, and approval of both facilities and products within the large molecule space. Well established industrial, academic and regulatory track record.
  • Demonstrated competency and experience with introduction of Drug Substance products to manufacturing sites and thorough technical knowledge of manufacturing site unit operations.
  • Understanding of costing systems to support COGS sensitivity assessments as well as financial tools such as NPV, P&L and make vs buy tools.
  • Integration of new and re-developed DS manufacturing processes from R&D into the supply chain.
  • Tech transfer from R&D facilities, internal and external, to plants in the JSC network. The scope includes early development, full development, launch phase and life cycle management.
  • Contribution, review and approval of DS technical and regulatory documents, routine technical support during execution, integration of Janssen Supply Chain (JSC) technical expertise into project execution
  • Single point of contact for JSC plant readiness and execution from technical transfer into commercial production. Identifying and implementing opportunities for active decrease in DS COGs. Taking part in GP assessments led by the NPL.
  • Partnering with R&D and JSC groups to improve the fit for plant and commercialization of new products into the supply chain.

2. Personal and interpersonal skills / Leadership skills

  • Demonstrated leadership in providing integration of activities, information across multifunctional groups and sites. Planning and logistics skills capable of effective integration of DS deliverables at the manufacturing site level.
  • Ability to foster team productivity and cohesiveness and to work collaboratively to execute, deliver and get results through the various matrix teams.
  • Ability to influence and lead peers, superiors, and external partners.

3. Personal attitude and mindset

  • Motivated, self-starter able to work independently with demonstrated problem solving skills.

DEGREE:

Engineer, Msc or equivalent in a technical field (Chemistry, Pharmaceutics, Biological Sciences, Chemical Engineering). Principal Scientist level will require at least 8-12 years of experience in the DS biopharmaceutical development or manufacturing arena. Senior scientist level will require at least 6-8 years of experience, and Scientist level will require 2-4 years of experience.

LANGUAGES:

Fluent in written and spoken English

SPECIFIC SYSTEMS:

Document mgmt. systems such as ERIS, Docspace, SAP, MS Office applications

TrackWise

lnstantis

Minitab or similar statistical software

PHYSICAL REQUIREMENTS/WORKING CONDITIONS: 

Travel: Min 10%- project dependent

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