CH - Engineer 3, Process
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Recipient Email Job Description Share Share Email Facebook Twitter Linkedin Print CH - Engineer 3, Process [Hochstrasse 201, 8500], Schaffhausen - Switzerland | Posted - 02/06/23 Overview Description:Technical Launch Integrator
We look for an English speaking professional
Availability on site ca. 1 day / week
POSITION SUMMARY:
The Technical Launch Integrator (TLI) has overall accountability for ensuring fit for plant and commercial readiness during technical development and execution of the transfer of pharmaceutical processes and products from Development into the supply chain and the global market place, as well as site-to-site transfers keeping Best Process/Product at Launch (BPAL) mindset.
Areas of key responsibility include DP sourcing & technical support and oversight for the supply chain, planning and execution of DP production, and manufacturing site level support of new product launch. The TLI is a member of the Manufacturing Site Operational teams, CMC Sub Team, and JSC Value Chain Team and leads the new product introduction team at the manufacturing site.
TASKS AND RESPONSIBILITIES
•Technical and manufacturing integration of new and re-developed drug products from R&D (DPDS or VPAD) into the supply chain by keeping Best Process/Product at Launch (BPAL) mindset.
•Contribution, review and approval of drug product technical and regulatory documents, routine technical support, integration of JSC/MSAT technical expertise of proven and matured (new and existing) technologies into project execution and QbD technical implementation at the manufacturing site level.
•Single point of contact for JSC plant readiness and execution from technical transfer into commercial production including launch support.
•Leading the manufacturing site team and taking the role of manufacturing site representative on the CMC Sub Team and the Value Chain Team (VCT).
•Identifying and implementing opportunities for active decrease of COGs and partnering with Development and JSC groups to develop and implement strategies to improve process robustness, fit for plant and commercialization of new products into the supply chain.
•Provide all manufacturing site related needs to the CMC Sub Team as the single point of contact at the site.
•Developing the manufacturing site execution plan per product, in line with the overall strategy and plan as outlined by the CMC Sub Team and JSC VCT. The TLI will ensure alignment and endorsement of this strategy within the manufacturing site and TLI function.
•Providing required manufacturing technical support, document technical input, review and approval and serving as the JSC technical expert.
•Coordinating and executing product introduction at the site from sourcing & transfer through launch covering raw materials, formula, process, packaging and device integration into the finished product and supporting the Value Chain Lead (VCL) for site related launch activities.
•Delivering clinical through commercial product supplied by the manufacturing site, ensuring manufacturing performance, cost, and process robustness requirements are met.
•Optimizing the new product introduction process, making use of JSC technology platforms, accelerating development timelines, streamlining the technical transfer process.
•Serving as the Supply Chain technical representative on the CMC Sub Team, site representative on the VCT, and leader of the product specific site team.
KNOWLEDGE SKILL AND ABILITY REQUIREMENTS:
•Knowledge of both pharmaceutical product R&D and Manufacturing / Technical Operations functions
•Knowledge of manufacturing & digital technologies, aseptic processing & development processes in LM Drug Product manufacturing
•Planning and logistics skills capable of effective integration of DP deliverables to support detailed execution at the manufacturing site level.
•Experience with introduction of pharmaceutical products to manufacturing sites and late stage development with technical knowledge of manufacturing site unit operations.
•Knowledge of manufacturing site systems and procedures; understanding of GMP requirements
•Demonstrated leadership in providing integration of activities and information across multi-functional groups and matrix teams.
•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 peers, superiors, and partners.
•Motivated, self-starter able to work independently with demonstrated problem solving skills.
DEGREE/Experience:
Minimum requirements: BS/BA with experience in pharmaceutical development or pharmaceutical manufacturing or related post graduate academic experience/education.
LANGUAGES:
Fluent in written and spoken English
SPECIFIC SYSTEMS:
Document mgmt. systems such as RIMdocs, TruVault, SAP, MS Office applications
Trackwise Planisware
Travel: Min 10%-25% - project dependent
Additional Details
Pool : (No Value) Actual End Date : Education Required : University/Bachelors Degree or Equivalent Job Function : Engineering Job Subfunction : Process Engineering Work Experience : Generally Requires 4-6 Years Work Experience Permanent Salary Equivalent Rate :-
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