Drug Product Tech Transfer Support Lead (Biologics)

8525-Cilag GmbH International Legal Entity; Schaffhausen; Sur place; CHF 140 000 - 190 000; Plein temps

Résumé du poste

Johnson & Johnson is seeking a Technical Launch Integrator—Senior Scientist within Global Manufacturing, MSAT, Bio DP L&G. You will ensure readiness for NPIs transferred from development to the commercial site and manage internal/external tech transfers for biologics.

Responsibilities include leading technical documentation, coordinating site readiness, and collaborating across cross-functional teams to improve process robustness and drive successful product launches.

Qualifications

• Bachelor's degree or higher in a relevant field (required).
• MS or PhD preferred in a bioscience/engineering discipline.
• 4+ years in pharma product R&D or MSAT/manufacturing roles (required).
• Experience with biopharma tech transfers to manufacturing sites (required).
• GMP knowledge and site systems understanding (required).
• Experience with DP late-stage development is a plus.

Responsabilités

• Review and approve drug product technical/regulatory docs for transfers.
• Provide routine technical support and QbD implementation at site level.
• Serve as single point of contact for site readiness and launches.
• Identify cost reduction opportunities and improve process robustness.
• Develop site execution plans aligned with cross-functional teams.
• Coordinate product introduction from transfer to launch across materials, formula, packaging, and device.
• Accelerate NPI timelines and streamline tech transfers across geographies.
• Collaborate across matrix teams to deliver results and drive improvements.

Connaissances

Technical Transfer

Biologics

NPI Launch

QbD

Project Management

Lean Supply Chain

Problem Solving

Formation

Bachelor's degree

MS/PhD

Outils

RIMdocs

TruVault

SAP

MS Office

Planisware

Description du poste

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).

Technical Launch Integrator (TLI)

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.

Responsibilities

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.

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

• 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
• Math (STEM) Application
• Situational Awareness
• Technical Research
• Technologically Savvy
• Validation Testing
• Vendor Selection

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
• Math (STEM) Application
• Situational Awareness
• Technical Research
• Technologically Savvy
• Validation Testing
• Vendor Selection

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.

Our Credo calls on us to respect the dignity of every individual and create an environment for all people to thrive.

Throughout the recruitment process - from application through hiring - we are committed to providing reasonable accommodations/adjustments for qualified candidates with disabilities. If you need support at any stage of the recruitment process, please complete our candidate accommodation request form so we can assist you.