Drug Product Tech Transfer Support Lead (Biologics)

Biopharma Asia; Schaffhausen; Presencial; CHF 110.000 - 160.000; Jornada completa

Descripción de la vacante

Johnson & Johnson in Schaffhausen, Switzerland, seeks a Technical Launch Integrator Senior Scientist for Bio DP L&G. You will drive site readiness for NPIs, manage tech transfers, and ensure successful biologics launches across internal and external sites.

Responsibilities include technical documentation, cross-functional collaboration, and QbD deployment. Travel up to 20% may be required; strong English skills are essential.

Formación

• Minimum of a Bachelor's or equivalent degree (required).
• M.S. or PhD (preferred).
• 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 GMP requirements (required).
• 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).
• Up to 20% domestic and international travel (required).

Responsabilidades

• Technical and manufacturing integration of new and re-developed drug products from R&D into the supply chain.
• Contribute and approve drug product technical and regulatory documents.
• Provide routine technical support and QA by Design (QbD) implementation at site level.
• Single point of contact for site readiness, execution and launch support.
• Identify cost reduction opportunities and improve process robustness for new products.
• Develop site execution plan per product aligned with cross-functional strategy.
• Coordinate product introduction from transfer through launch across materials, formula, process, packaging, devices.

Conocimientos

Agile Decision Making

AI Judgement Integration

Coaching

CAPA

Problem Solving

Process Engineering

Lean SCM

Technical Transfer

Team Collaboration

Educación

Bachelor's or equivalent

M.S. or PhD

Herramientas

RIMdocs

TruVault

SAP

MS Office

Comet

Planisware

Descripción del empleo

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

Job Function:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Schaffhausen, Switzerland

Job Description:

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/ .

Introduction and Overview

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).

Objectives of the Position

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.

What you will need to succeed

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.

Qualifications:

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)

Required Skills:

Preferred Skills:

• Agile Decision Making
• AI Judgement Integration
• Coaching
• Corrective and Preventive Action (CAPA)
• Critical Thinking
• Emerging Technologies
• Issue Escalation
• Lean Supply Chain Management
• Problem Solving
• Process Control
• Process Engineering
• Product Costing
• Product Improvements
• Science
• Technology
• Engineering
• and Math (STEM) Application
• Situational Awareness
• Technical Research
• Technologically Savvy
• Validation Testing
• Vendor Selection