Sr Manager Operational Readiness (m/f/d)

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 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.

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Job title : Senior Manager Operations

Function: Supply Chain Manufacturing

Sub function: Manufacturing Pharmaceutical Process Operations

Category: Senior Manager, Manufacturing Pharmaceutical Process Operations (PL8)

Location: Sassenheim / Netherlands

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

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Senior Manager Operations to be in Sassenheim, Netherlands!

BU5-LVV in Sassenheim is a new Johnson & Johnson Supply Chain Lentiviral Vector (LVV) production facility, designed to support the global Johnson & Johnson BCMA CAR-T program for multiple myeloma—a disease affecting ~160,000 patients annually. This brand new biologics manufacturing site will play a key role in advancing patient care.

As a Senior Manager Operations , you are accountable for ensuring a seamless startup of the new Capacity expansion project at the existing Lenti Viral Vector manufacturing site at the Sassenheim location (Advanced Therapies). The Senior Manager Operations is, as a project manager, also accountable for hiring and training of all staff and in-time availability of all relevant operational documentation in compliance with EHSS, cGMP regulations requirements.

Furthermore, the Senior Manager Operations is accountable for a design of the expansion ensuring long-term production capacity including but not limited to the cleanrooms, process equipment, additional office space and improvements required based on lessons learned from the original capex project.

You will be responsible for:

• Overseeing and coordinating all project activities across the project to ensure the seamless execution processes, driving alignment, efficiency, and timely delivery

• Keeping manager and key project stakeholders updated on project issues, issue resolution, risks and overall status of project.

• Delivering organizational blueprint to operate the expanded Lentivirus facility.

• Delivering manufacturability / operational input for the design of the new facility.

• Delivering change control strategy for operations.

• Leading and coordinating the change control process.

• Delivering documentation structure and strategy for all departments; operations, QA, QC, GET, etc.

• Ensuring relevant documentation is approved to support start up.

• Ensuring all disposables and raw materials are qualified.

• Ensuring all production areas are GMP certified.

• Providing staff to run the validation batches.

• Updating the budget (OPEX/CAPEX) and headcount model and CIP for the business unit.

• Building and maintaining a solid network within JBV, with other J&J sites and external parties such as regulatory agencies, contractors, partners and vendors as needed.

• Ensuring best practice sharing across JBV and J&J sites.

• Working closely and successfully with the Capex team.

Project Management:

• Working effectively in a Global multi-functional team environment, brainstorm solutions, develop practical innovative cost-effective design concepts, and lead change.

• Supervising and managing the project team.

• Responsible for sufficient level of training, knowledge (process, process excellence etc) and occupancy to ensure the project team functions effectively and can perform their duties.

• Ensuring team stability and creates and maintains a positive atmosphere and high morale.

• Responsible for the required administrative reports/documentation.

• Ensuring the best people are in the best places.

CGMP, EHS&S, LEAN, PROCESS EXCELLENCE and DIGITAL CAPABILITIES

The Senior Manager Operations is accountable for a safe and sustainable work environment (as well as physical and mentally).

Is a Credo champion in the way the job is institutionalized and a role model of leadership. Makes the team aware of unsafe situations to prevent accidents to happen. Follow through of incident management (e.g. ECB, incident lists, form 130).

Accountable for first or second line (depending on the defined department) assessment of process operation according set standards as EHSS / cGMP/ internal guidance.

They also ensure that processes are followed and that both processes and work environments are continuously improved upon to quality of cGMP and EHSS, with support of Process excellence principles. Furthermore, the job holder has knowledge of cGMP, EHSS and Process excellence on a level suitable to this position. The job holder also ensures their team has the correct knowledge of cGMP, EHSS and Process excellence, WOF (Workforce Of the Future) and digital capabilities so they are proficient in the required skills.

The Senior Manager Operations is furthermore accountable that everyone is properly trained in, and adheres to internal procedures and standards. They observe and stimulates opportunities for improvement and sets out a clear course to implement improvements in areas in need of improvement. They implement improvements, both within their own department as company-wide and stimulates their employees to do the same.

Qualifications / Requirements

• Bachelor certification in a relevant topic e.g. (bio)science, process engineering.

• 8 years practical industrial experience and 5 years’ experience in a managerial position.

• Shown excellent GMP awareness & experience.

• Excellent communication skills in English (Dutch preferred).

• Shown excellent EHS&S awareness.

Essential skills and behavior:

- Data gathering and analyses: Collects and synthesizes information to enable strategic decision making. Uses a variety of data analysis tools, techniques, and methodologies

- Supply chain knowledge: Understands key principles and priorities central to effective supply chain management. Understands the market dynamics and the economies of scale, supply, and demand.

- Accountability: Takes responsibility for one's actions regardless of outcomes. Feels accountable for the quality and timeliness of an outcome/task.

- Motivating Others: Encourages and promotes peak performance in others. Creates an environment which enables success. Drives organizational energy and passion

- Resilience: Is able to manage stress productively. Takes a proactive approach to assessing, managing, and recovering from stress. Is able to bounce back in the face of mounting pressure.

The anticipated base pay range for this position is 82.900,00€ to 144.210,00€

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Preferred Skills: