Easter Seals Jobs

MSAT LM DS Site Director (onsite) - 2406202232W

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/.

Johnson & Johnson Innovative Medicine, Supply Chain is recruiting for a MSAT LM Site Director - Leiden , who has the responsibility for the management of the MSAT department in Leiden.

The MSAT Director manages a highly engaged world-class site MSAT team providing strategic leadership and direction aligned with the site, Large Molecules and Advanced Therapies network with the dedicated focus on:

• LCM - Technology transfer coordination at site / NPI Support

• PQ, validation execution (Process and Cleaning Validation)

• Process improvements execution

• Standards deployment, PAT, technology

The MSAT Director will report solid line to the MSAT LM Platform Lead and dotted line to the Site General Manager and have a strong connection with the MSAT Advanced Therapies Platform Lead and be a member of the site SLT. She/ He will lead a team of Managers, Scientists and Engineers (Cleaning and Process Validation Experts and Project Managers) across the Site Business Units in span of control of the site.

Being accountable for the Validation Masterplan and execution of related Performance Qualification, Life Cycle Management Process as well as Cleaning Validation. Being System Owner of Validation and PQ and therefore accountable for Regulatory Inspection for area of responsibility.

The MSAT Director/ is responsible for day-to-day PQ & Validation Management as well as related Project Execution, including supporting NPI or Life Cycle Management initiatives. In addition, he/ she will be responsible for the execution of standards and delivery of business results on site.

Responsibilities

The core responsibilities for this role are as follows:

• The MSAT Site Lead manages an MSAT team with focus on execution of Product Transfer /supporting Product Introduction for the Site, Life Cycle Management Process and cleaning validation, process improvements in support of technology and product technical life cycle management and deployment of standards.

• The MSAT Site Lead and his/her team are accountable for the Validation Masterplan and execution of related Performance qualification, and Process as well as Cleaning Validation.

• System Owner of Validation and PQ and therefore accountable for Regulatory Inspection for area of responsibility. This includes technical support in partnership with Quality on any regulatory audits and inspections and being the Spokesperson in Audits internal and external.

• Partnering with MAM and Production on Project Oversight of assigned projects.

• Partnering with Product Stream Leads and other MSAT platforms and COEs, site GM and BUs on project priorities.

• Single Point of Contact (SPOC) for Site MSAT needs responsible for managing MSAT team’s contribution towards manufacturing floor support, investigations of major/critical process deviations, impact assessments, process monitoring/continued process verification, /process improvements, process improvement projects, change management, and data analytics.

• Drives accountability of self and others and creates an environment of innovation and experimentation that facilitates creativity and idea sharing.

• Monitor technical process and product performance.

• Monitoring and continuous improvement of MSAT KPIs.

• Accountable for managing team in accordance with Site and MSAT priorities following the JSC Business Cascade (Budgeting, Resources).

• Motivates and inspires site MSAT team to drive significantly increased performance through technical innovation and change. Provides leadership and development to the team and ensures there is a diverse pipeline of high performing multi-skilled leaders of the future.

• Owns and executes initiatives and projects related improvement programs, implementation of new capabilities and capacity.

• Develops and deploys technology standards and its applications through assets and products.

• Drives a Credo-based culture.

• Handles all aspects of managing personnel, including hiring and terminations. Provides coaching and development opportunities. Evaluates performance and provides feedback. Implements disciplinary actions, as necessary.

Qualifications

PERSONAL & INTERPERSONAL SKILLS / LEADERSHIP SKILLS

• Ability to lead cross functional / cross-platform project team.

• Ability to manage complexity and change.

• Ability to interact at various levels of the organization (including Sr. Management)

• Ability to work under pressure, handle conflicting interests, and take decisions.

• Ability to work independently under general direction, having a good sense of prioritization of assigned tasks goals and manage time accordingly.

• Ability to create a result-oriented (project) team.

PERSONAL ATTITUDE & MINDSET

• Servant - Leader mentality (Lean culture - role of leadership)

• Drives for innovation and change to ensure competitiveness.

• Can-do mentality: takes initiative, creates a result-oriented working spirit in his/her team.

• Effective communication, presentation, and negotiation skills

• Intellectual Curiosity

• Sense of Urgency

• Self-Awareness and Adaptability

Qualifications, attitude and mindset

• A Master’s degree Chemistry, Pharmaceuticals, Engineering, or related area is required. An advanced degree is preferred.

• A Minimum of 10 years of experience in Drug Substance pharmaceutical development or pharmaceutical manufacturing or related post graduate academic experience/education is required.

• Knowledge of both Pharmaceutical Manufacturing and MSAT functions and experience with Large molecules and/or Parenterals is preferred.

• Demonstrated leadership in providing integration of activities and information across multifunctional groups and matrix teams is preferred.

• Ability to foster team productivity and cohesiveness and to work collaboratively to execute, deliver and get results through the various matrix teams is preferred.

• Excellent written and oral communication skills and ability to influence peers, superiors, and partners is required.

• Motivated, self starter able to work independently with demonstrated problem solving skills is required

• Driver for innovation and change to ensure competitiveness

• Intellectual Curiosity

• Sense of Urgency

• Self-Awareness, adaptability & ability to manage complexity and change.

• The role is based in Leiden and will require up to 10% international travel.

We are offering you a multifaceted challenge in a dynamic, international environment with attractive terms and an excellent infrastructure.

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.

Primary Location Europe/Middle East/Africa-Netherlands-South Holland-Leiden

Organization Janssen Biologics (7266)

Job Function Manufacturing Engineering

Req ID: 2406202232W