Johnson & Johnson
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Introduction and Overview Cilag GmbH International, a member of the Johnson & Johnson Family of Companies, is recruiting for a Technical Launch Integrator - Principal Scientist MSAT Large Molecule Drug Product Launch & Grow (LM DP L&G) .
Objectives of the Position The Technical Launch Integrator (TLI) has overall accountability for ensuring fit for plant and commercial readiness during technical development, including implementation of new innovations & technologies. Key responsibilities include:
Technical and manufacturing integration of new and re-developed drug products from R&D into the supply chain.
Contribution, review, and approval of drug product technical and regulatory documents.
Routine technical support and integration of supply chain technical expertise into project execution.
Quality by Design (QbD) technical implementation at the manufacturing site level.
Single point of contact for supply plant readiness and execution and launch support between Development and Commercial supply chain organizations.
Identify and implement opportunities for active decrease of COGs.
Develop the manufacturing site execution plan per product.
Coordinate and implement product introduction at the site from transfer through launch.
Optimize the NPI process and streamline the technical transfer process.
What You Will Need to Succeed To be successful in this role, you will need:
Ability to foster team efficiency and cohesiveness.
Motivated, self-starter able to work independently with proven problem-solving skills.
Qualifications Minimum qualifications include:
Minimum of a Bachelor's/University or equivalent degree (required).
M.Sc. or PhD (preferred).
Minimum 6 years of relevant work experience with pharmaceutical product R&D and/or Manufacturing / MSAT functions (required).
Experience with technical transfer of biopharmaceutical products into manufacturing sites (required).
Knowledge of manufacturing site systems and procedures, including an understanding of GMP requirements (required).
Knowledge of DP late-stage development (preferred).
Experience with document management systems such as RIMdocs, TruVault, SAP, MS Office applications, Trackwise, and/or Planisware (preferred).
FPX, PMP, or equivalent Project Management certification (preferred).
Proficient in English (required) and German (preferred).
May require up to 20% domestic and international travel, depending on project needs.
Application Are you interested in joining a team that is passionate about groundbreaking biomedicine operations that positively improve the lives of patients? Do you want to work for an employer with an excellent record in employee continuous professional development and business improvement? Apply today to J&J! Please apply with an updated CV and Cover letter in English.
The selection process will start during the posting period, please send in your application as soon as possible. We reserve the rights to close the advert earlier. All applicants can expect feedback on the application.
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