Manager NPI (onsite)

Description

Johnson & Johnson is currently seeking a NPI Manager to join our Lenti Viral Vector Facility located in Sassenheim. 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/.

The Lenti Viral Vector Facility / Pollux project: Janssen Biologics B.V., part of Johnson & Johnson, is setting up a new production facility in Sassenheim. This facility will produce lentiviral vector, which is used at the CAR-T sites for the treatment of several types of blood cancer. The New Product Introduction team (NPI) is an essential support group in the LVV Facility. The team has the following major roles

1. Ensure a smooth tech transfer of new products to the shop floor.

2. Ensures a smooth tech transfer of improvements to existing processes or develops new and improved basic processes

The NPI team is a critical team in the direct support of Operations when it comes to the introduction of new Lenti Viral Vectors. The NPI team is key in clear translation of the developed process to a workable process and environment for the shop floor. The NPI team always works against the high-quality standards and safety and compliance regulations that are applicable for LVV manufacturing. The NPI team is a multifunctional team of around 10 - 15 people consisting of staff and contractor personnel. The NPI team is one of 3 departments within the LVV facility. The other two are: Operations Department (OPS) and CoE.

Essential Job Duties and Responsibilities

The NPI Manager provides leadership and direction for the Process leads, Manufacturing specialist resources and activities. Partners in the LVV facility with Operations and CoE in the introduction of new products and a smooth transition from one product to the other. Encourages and supports the identification and development of innovative solutions to problems and opportunities.

• Acts as project lead of the receiving site
• Support process fit-to-plant methodology
• Facilitates resolution of complex process- & technical problems.
• Promotes innovation initiatives for new processes, products and ideas.
• Reviews and approves technical documentation to verify compliance to technical specifications and standards.
• Communicates with internal and external departments (R&D, OPS, QA, QC, MAM, MSAT, IT) to coordinate and execute the tech transfer.
• Assigns tasks according to projected scopes including compliance and quality improvement, capacity increase, raw material qualification, and launch preparation.
• Monitors smooth execution of plans and programs at lower levels and cross functionally that impacts the tech transfer
• Supports intime closure of Change Controls
• Allocates proper level of resources to facilitate attainment of goals within established timelines and budgets.
• Ensures departmental and company compliance with all local government and company regulations, policies and procedures for health, safety and environmental compliance.

Qualifications

Minimum Qualification

• Bachelor or University degree in preferably Engineering or Science or equivalent Technical subjects like Mechanical-, Electrical-, Automation- or Process engineering

Other Requirements

• 6-8 years relevant work experience as people leader (Supervisor and/or Manager) with leading and directing teams and/or departments.
• >10 years’ experience in Pharmaceutical (GMP) production environment.
• Tangible experience of successful implemented LEAN projects both on content as leadership
• Knowledge of EHSS standards and regulatory requirements in relation to LVV Production
• Knowledge of the production process and GMP requirements.
• Knowledge of Global JJOS methodology and systems.

Key competences:

• Stress resistant: stays calm and emanates peace, also in complex situations. Deals with changing priorities under time pressure.
• Good analytical and problem-solving abilities and abilities to deal with complexity: Interprets facts, makes connections between multiple signals and aims to find root causes. Perceives obstacles, both short- and mid-term. Shows a high degree of original and independent thinking, often under time pressure, to maintain manufacturing activities.
• Decisive: Supports and takes decisions based on facts, data and the transcending angles (Departmental and business unit transcending). Searches for a balance between the needs of, and the impact on, those involved.
• Quality oriented: checks and coaches the adherence to, and improvement of quality requirements and standards.
• Cooperation and communication: Builds and maintains solid and productive relationships both within and outside of the department. Organizational abilities in a complex environment.
• Leadership: Can lead a team of highly qualified professionals who operate in different fields of expertise while keeping overview, progress, motivation, innovation and delivery on targets on track.

Additional leadership competences:

• Operational leadership: Empowers the NPI team to lead and deliver on the business targets for the next 3-6 months. Demonstrates good people management skills to his/her direct reportees. A high degree of inventiveness and resourcefulness are required to ensure deadlines are achieved, standards maintained, and the individual team member remains motivated and functioning at good efficiency.
• Tactical leadership: Leads the development and roll out of tactical plans for the next 6-12 Months.
• Strategic leadership: Supports the set up and roll out of the strategic goals.
• Diversity & Inclusion: Makes optimal use of diverse talents, knowledge and skills.
• Development and recognition of talent: ensures the development of the individual, team and department
• Recognizes, acknowledges and involves employees with different backgrounds, talents, knowledge and ideas within the LVV and the J&J as a whole and ensure these are involved in the decision process to improve results. (Unity)
• Uses a regular system (1-2-1’s/Gemba’s/5 conversations) to periodically determine the progress and technique of their employees and gives clear indications, instructions and tasks (supports the employee on their level).
• Creates a safe environment in which everyone is comfortable and dares to discuss matters (i.e., barometer check/Credo survey). Visibly motivates and appreciates employee input.
• Knows their own leadership style (Insights) and can adapt it to the situation, group, person or need (agility) to achieve a set goal.

Additional visibility & motivation & inspiration competences:

• Knows their responsibilities and takes visible ownership of them (i.e.: actively asks for help, accepts and motivates the use of standards).
• Stimulates and appreciates open communication when mistakes are made/ problems arise.
• Approaches mistakes and setbacks objectively and rationally and proposes new goals, priorities and improvement plans; Coaches and corrects coworkers when necessary.
• Is aware of and demonstrates good ‘storytelling’ and is clear on the WHY of important changes and decisions; and communicates these with impact.
• Has participative dialogues in which leaders listen and employees talk. Ensures decisions are taken during (team)meetings. Safeguards the prioritization.

Additional cooperation competences:

• Makes and utilizes and guides others to make connections on site and Campus/NL level, which increase insight and strategic value for the company.
• Names common and complementary factors in the team to strengthen the team’s spirit, climate, results and processes and shows employees that their talents/insights contribute to the improvement of the desired common goal.

Additional integrity competences:

• Observes, listens, questions, changes leadership style when necessary and analyses where in the interactions and processes problems emerge. Helps clear up the difference between cause and effect and gives employees insight in their complimentary attributes.
• C redo: Uses the credo actively and acts as a role model and stimulates others to do the same.

Additional Innovation competences:

• Stimulates a progressive learning culture by acknowledging individuals, having an environment in which new ideas and solutions are actively sought after, supporting innovation and continuous improvement, and having a culture in which mistakes are learned from and decisive action is supported.
• Ensures improvements are submitted through the correct ‘communication route’.
• Thinks (open mindset) and talks in terms of possibilities instead of problems and thinks critically and creatively to challenge the status quo and/or anticipate changes. (leading change)

Additional learning competences:

• Views self-improvement as a priority and acts as a role model. Guides coworkers to find ways to improve their achievements and development in a stable manner. Uses the 5 conversations cycle and 1-2-1’s consistently to execute this.
• Regularly delivers and requests feedback in a proactive and respectful way and sees it as a tool to develop themselves and employees continuously.
• Is capable of absorbing complex information, identifying the entire problem and integrate the solution in their own procedure and/or utilize it for their organization.

Additional analytical competences:

• Successfully recognizes and solves problems by actively gathering information, analyzing and connecting multiple signals and sources and discovering the root cause/suggesting a solution to the problem.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.