MSAT Staff Engineer

At Janssen Supply Chain Latina (Italy), the global Manufacturing Science and Technology (MSAT) team is hiring a Staff Engineer (PG26) for a permanent position, recommended as a lateral move.

Are you interested to join the Global MSAT Value Optimize team that focusses on Small Molecule Drug Products at Janssen Latina?
You will be part of the Global Manufacturing Science and Technology (MSAT) organization, a worldwide organization of technical experts. The Value Optimize Team within the Small Molecule Drug Product (SM DP) platform is managing all technical aspects of the existing product portfolio while contributing to the product supply towards our Patients.
This position focuses on the solid dose manufacturing product portfolio.
Main responsibilities of the role are the Drug Product Technical Ownership (DPTO) throughout the product’s lifecycle, site-to-site technology transfers and collaboration on technology and innovation deployments.

Qualifications

Do you have strong technical leadership and project management skills, and do you have a passion for manufacturing process excellence and innovation? If so, then you may be the person we are looking for!

This is what awaits YOU in this role :

• A multifaced and inspiring work environment, within a broad professional network. And, teamwork across local and global functions and sites (internal and external), offering possibilities for further personal and professional growth.
• For the assigned product portfolio, as a DPTO you own all technical aspects and act as the collaborative link between MSAT leadership and the Value Chain Teams. You are monitoring technical process and product performance across internal and external manufacturing site and own the product Criticality Analysis and related control strategy. You are representing MSAT in the Value Chain Teams and lead a network of functional experts to ensure the required technical support to the Value Chain Teams. You are involved in business strategy discussion (e.g. identification and implementation of Gross Profit improvement initiatives), resource estimations and budgeting that will further strengthen your eye for business.

§ You are responsible for optimal lifecycle management initiatives that drive portfolio risk reduction, add business value (e.g. cost improvements and lead time reductions) and provide support to the local MSAT teams of internal and external sites in case of complex quality investigations. For collaborations with the Contract Manufacturing Organizations (CMO) you work closely with the MSAT External Site leads who are the Single Point of Contact for the CMO’s and act as single MSAT voice for all site-related technical matters. Furthermore, for process LCM you will work closely with the newly established MSAT Scientific teams of Process Scientists.

Education:
§ Master degree in a Scientific or Engineering field such as Chemistry, Process Technology or Pharmaceutics or achieved by experience.
Experience and Skills :
Required :

• At least 7 years of relevant work experience solid dosage drug product manufacturing or development, with technical background in processing requirements and techniques, SM DP mfg unit operations, process and cleaning validation, material science, quality, c GMP and regulatory knowledge.

§ Experience in validation strategy setting and implementation plan definition for changes throughout the product lifecycle.
§ Possesses an understanding of the SM DP business environment, understands strategic business plans and demonstrates a strong understanding of J&J business processes.
§ Project management skills as well as leading and motivating multi-functional project teams.

• Effective communication skills across all levels of the global matrix organization, including the ability to lead others without direct line authority and the ability to solve conflicts.

§ Strong problem solving and critical thinking skills that enable complex decision making:

• Ability to perform (risk) assessments based on data and make recommendations based on scientific justifications.
• Ability to lead technical teams in support of Root Causes Analysis for quality issues and Supply Chain escalations.
• Basics of data analysis skills to support Continued Process Verification, quality investigations and other process robustness evaluations.
• Personal, interpersonal and leadership skills :
• Motivated, self-starter able to work independently with demonstrated problem solving skills.
• Ability to foster team productivity and cohesiveness and to work collaboratively to execute, deliver and get results through the various matrix teams.
• Ability to navigate through the organization and obtain the required professional support where needed by influencing and leading peers, superiors, and external partners, including interaction with senior management
• Ability to work independently under general direction, having a good sense of prioritization to deliver on commitments and manage time accordingly.
• Ability to manage through complexity and change.
• Challenges the status quo, t akes initiative, drive innovation and show a ‘can-do’ mentality and creates a result-oriented working spirit in his/her team.
• Positive attitude and customer focus
• Ability to work under pressure and resolve conflicts

§ Basic financial knowledge/tools to support COGS sensitivity assessments such as NPV, P&L and make versus buy tools.

• Fluent English (written and spoken)

Preferred:

• International experience and interest in collaborating with various cultures, nationalities and perspectives.
• Experience in new technologies like Continuous Manufacturing is definitely a plus.
• Experience in leading and/or applying Kepner Tregoe Root Cause investigation methodology and ability in recommending effective solutions.
• Basic Statistics understanding.
• Green/Black belt certification.