Operations Readiness Lead

Johnson & Johnson Innovative Medicine; Kansas; On-site; USD 180,000 - 240,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Wilson, NC, is seeking a senior engineering leader to design and set up manufacturing operations for parenteral products. You will ensure GMP/ISO compliance and align operations with production schedules while guiding a multidisciplinary team through a large greenfield project.

The role requires extensive experience in pharmaceutical operations, leadership across functions, and a strong focus on safety and continuous improvement.

Qualifications

• Bachelor’s degree in engineering, Science, or equivalent technical field is required; MS or equivalent experience preferred.
• Minimum of 12 years of experience within pharmaceutical or GMP regulated operations environment with specific knowledge of parenteral drug product manufacturing.
• Proven capability of leading and implementing transformational change, as well as being able to effectively communicate and influence at all levels of the organization.
• Experience managing partnerships and cross-functional teams.
• Experience working in a matrixed organization.

Responsibilities

• Lead design and set-up of manufacturing operations for parenteral drug products to ensure products are produced in compliance with cGMP, ISO, and other Regulatory requirements.
• Support the design of the manufacturing processes and areas in the construction of the new facility.
• Ensure that operations activities are planned and performed to meet business needs, customer needs and production schedule.
• Promote a culture of continuous improvement and open communication.
• Using performance management, people development, talent planning and other processes to lead, empower and develop individuals within operations.
• Shaping the site outcomes and new organization design as part of the Project Leadership team.
• Lead and sponsor multi-functional teams to support site objectives.
• Providing strategic/operational leadership to the capital project.
• Lead by example and always strive to perform in compliance with Credo and Global Leadership Profile
• Responsible for ensuring the safety of our operations employees and for following good environmental practices and procedures.
• Demonstrate safe behavior in every activity.
• Provide support to Project Commissioning, Qualification and Validation activities and actively support the Technology Transfer process for each new product

Skills

Parenteral manufacturing

GMP/Regulatory

Cross-functional leadership

Problem solving

Matrix organization

Team leadership

Communication

Education

Bachelor's degree in engineering

MS preferred

Job description

Job Function:

Supply Chain Engineering

Job Sub Function:

Facilities Engineering

Job Category:

People Leader

All Job Posting Locations:

Wilson, North Carolina, United States of America

Job Description:

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

Learn more and apply to this exciting new role for a Green Field Project!

Key Responsibilities:

• Leading the design and set-up of manufacturing operations for parenteral drug products to ensure products are produced in compliance with cGMP, ISO, and other Regulatory requirements.
• Supporting the design of the manufacturing processes and areas in the construction of the new facility.
• Ensuring that operations activities are planned and performed to meet business needs, customer needs and production schedule.
• Promoting a culture of continuous improvement and open communication.
• Using performance management, people development, talent planning and other processes to lead, empower and develop individuals within operations.
• Shaping the site outcomes and new organization design as part of the Project Leadership team.
• Lead and sponsor multi-functional teams to support site objectives.
• Providing strategic/operational leadership to the capital project.
• Lead by example and always strive to perform in compliance with Credo and Global Leadership Profile
• Responsible for ensuring the safety of our operations employees and for following good environmental practices and procedures. Demonstrate safe behavior in every activity.
• Provide support to Project Commissioning, Qualification and Validation activities and actively support the Technology Transfer process for each new product

Qualifications

Education:

• Bachelor’s degree in engineering, Science, or equivalent technical field is required ; MS or equivalent experience preferred

Experience and Skills:

Required:

• Minimum of 12 years of experience within pharmaceutical or GMP regulated operations environment with specific knowledge of parenteral drug product manufacturing.
• Proven capability of leading and implementing transformational change, as well as being able to effectively communicate and influence at all levels of the organization
• Proven experience in managing partnerships and cross-functional teams
• Good problem-solving skills
• Experience managing diverse, multi-disciplinary teams with varying degrees of educational background.
• Excellent interpersonal skills, ability to lead a team and operate as a part of team
• Track record of building strong teams, attracting, and developing outstanding talent, motivating them through challenging circumstances and provide guidance & coaching as needed
• Experience working in a matrixed organization.

Preferred:

• Leadership experience in a greenfield project(s)

Other:

• This position will be located in Wilson, North Carolina, and will require full time on-site support. However, the design of the facility will occur at an Engineering firm with frequent travel (> 75%) required until the project shifts to the plant site of Wilson, NC
• For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com].
• Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
• Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Budget Management, Chemical Engineering, Developing Others, Facilities Engineering, Fact-Based Decision Making, Inclusive Leadership, Leadership, Lean Supply Chain Management, Managerial Courage, Plant Operations, Program Management, Project Schedule, Regulatory Compliance, Resource Planning, Science, Technology, Engineering, and Math (STEM) Application, Talent Management, Vendor Selection