Drug Product Tech Transfer Lead Role (Biologics)

Johnson & Johnson Co.; Ringaskiddy; On-site; EUR 110,000 - 160,000; Full time

Job summary

Johnson & Johnson is seeking a Technical Launch Integrator (TLI) with broad Experience in Drug Product tech transfer and supply chain readiness. You will lead cross-functional efforts to ensure plant and commercial readiness during development, oversee site transfers, and drive cost- and time-efficient product launches across global networks.

Responsibilities include coordinating product introductions, supporting DP unit operations knowledge, and implementing QbD at manufacturing sites.

Qualifications

• Bachelor's degree or equivalent; MS or PhD preferred.
• 6+ years of pharma product R&D and/or Manufacturing (MSAT) experience.
• Experience with technical transfer of biopharmaceutical products into manufacturing sites.
• Knowledge of GMP requirements.
• DP late-stage development experience preferred.
• PM/FPX certification preferred.
• Proficient in English; up to 20% travel.

Responsibilities

• Technical and manufacturing integration of new and re-developed drug products from R&D into the supply chain.
• Review and approval of drug product technical/regulatory documents; provide routine technical support.
• Single point of contact for supply plant readiness and launch support between Development and Commercial supply chain.
• Identify opportunities to reduce Cost of Goods and improve process robustness and commercialization.
• Develop the manufacturing site execution plan aligned with cross-functional strategy.
• Coordinate product introduction at site from transfer to launch including materials, formula, process, packaging, and device integration.
• Optimize the NPI process and accelerate development timelines.

Skills

Agile Decision Making

Business Savvy

Process Engineering

CAPA

Critical Thinking

Disruptive Innovations

Emerging Technologies

Lean Supply Chain

Project Schedule

Technical Research

Education

Bachelor's degree

MS or PhD

Tools

RIMdocs

TruVault

SAP

MS Office

Comet

Planisware

Job description

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

Beerse, Antwerp, Belgium, Leiden, South Holland, Netherlands, Ringaskiddy, Cork, Ireland, Schaffhausen, Switzerland, Zug, Switzerland

Job Description

The Technical Launch Integrator (TLI), posted as Drug Product Tech Transfer Lead, has overall accountability for ensuring fit for plant and commercial readiness during technical development, including implementation of new innovations & technologies. The TLI is also responsible for the execution of the transfer of pharmaceutical processes and products into the supply chain and the global marketplace, as well as site-to-site transfers keeping the Best Process/Product at Launch (BPAL) mindset. Areas of key functions include DP technical support and oversight for supply chain, planning and execution of DP manufacturing site level support of new product launch.

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 supply plant readiness and 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.

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 6 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, Business Savvy, Coaching, Corrective and Preventive Action (CAPA), Crisis Management, Critical Thinking, Disruptive Innovations, Emerging Technologies, Industrial Hygiene, Lean Supply Chain Management, Organizing, Process Control, Process Engineering, Product Costing, Program Management, Project Schedule, Science, Technology, Engineering, and Math (STEM) Application, Technical Research

Preferred Skills

Agile Decision Making, Business Savvy, Coaching, Corrective and Preventive Action (CAPA), Crisis Management, Critical Thinking, Disruptive Innovations, Emerging Technologies, Industrial Hygiene, Lean Supply Chain Management, Organizing, Process Control, Process Engineering, Product Costing, Program Management, Project Schedule, Science, Technology, Engineering, and Math (STEM) Application, Technical Research