Drug Product Tech Transfer Support Lead (Biologics)

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Global Manufacturing, Science & Technology (MSAT) is recruiting for a Technical Launch Integrator Supporter – Senior Scientist; MSAT Biotherapeutics Drug Product Launch & Grow (Bio DP L&G).

The Technical Launch Integrator (TLI) is a JnJ term for someone who has accountability for ensuring site readiness for NPI (new product introduction) which are transferred from development to commercial site and also has ownership of any secondary tech transfers internally or externally.

In this role you will support a TLI to ensure the flawless execution of the tech transfer and ensure successful launch of biologics as well as site-to-site transfers (internal & external).

• Technical and manufacturing integration of new and re-developed drug products from R&D into the supply chain while using new innovations & technologies keeping the Best Process/Product at Launch (BPAL) mindset.
• Contribution, review, and approval of drug product technical and regulatory documents, routine technical support, integration of supply chain technical expertise into project execution, and Quality by Design (QbD) technical implementation at the manufacturing site level.
• Single point of contact for manufacturing site readiness, execution and launch support between the Development and Commercial supply chain organizations.
• Identify and implement opportunities for active decrease of Cost of Goods (COGs) and partner with Development and supply chain groups to implement strategies to improve process robustness, fit for plant, and commercialization of new products into the supply chain.
• Develop the manufacturing site execution plan per product, in line with the overall strategy and plan as outlined by the relevant cross-functional teams; ensure alignment and endorsement of this strategy within the manufacturing site and TLI function.
• Coordinate and implement product introduction at the site from transfer through launch covering raw materials, formula, process, packaging, and device integration into the finished product.
• Optimize the New Product Introduction (NPI) process, make use of technology platforms, accelerate development timelines, and streamline the technical transfer process.

Ability to foster team efficiency and cohesiveness and to work collaboratively to implement, deliver and get results through the various matrix teams, and influence with or without direct authority. Comfort working in a global team, across time zones, cultures and languages to influence different teams, to ensure successful tech transfers.

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

• Minimum of a Bachelor's or equivalent degree (required). M.S. or PhD .
• Minimum 4 years of relevant work experience with pharmaceutical product R&D and/or Manufacturing / MSAT functions, or equivalent (required).
• Experience with technical transfer of biopharmaceutical products into manufacturing sites, including technical knowledge of DP unit operations (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, Comet, and/or Planisware (preferred).
• FPX, PMP, or equivalent Project Management certification (preferred).
• Proficient in English (required) language.
• Up to 20% domestic and international travel, depending on project needs (required)

Are you interested in joining a team that is passionate about groundbreaking biomedicine operations that positive 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.