Senior Manufacturing Team Lead

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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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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 are searching for the best talent for a Senior Manufacturing Team Lead to join our Team! This is an onsite/hybrid role.

Position Summary

Reporting to the Cell Culture Purification or Manufacturing Science and Technology (MSAT) Manager this position is responsible for coordination organization and scheduling of shift teams activities within the Operations department. This includes managing of resources and leadership of the Operations shifts to ensure that shift targets are met. These activities include (but are not confined to):

General Activities

• Working assigned day or shift patterns to meet business needs and operations schedule.

• Coordination of operations team to meet production schedule in a safe compliant and cost-effective manner.

• Completion of pulse walkdowns to ensure compliance with all regulatory requirements particularly in relation to the pharmaceutical industry health and safety requirements and environmental legislation and cGMP requirements.

• Troubleshooting of process issues and escalating/collaborating with relevant support to resolve in a timely and effective manner.

• Review and approval of completed batch records.

• Support of Project and Commissioning/ Qualification activities as required.

• There are 2 specific areas in the manufacturing process and each area has individual responsibilities and requirements outlined below:

Cell Culture Activities

• Employ strict aseptic technique to all cell culture activities.

• Continuous monitoring of cell culture process.

• Set up and assembly of the Bioreactor Single Use Bioreactors.

• Manage Harvest release and DPC processing accurate buffer requirements.

• Strong focus on reliability.

Purification Activities

• Chromatography processing of biopharmaceutical product using Unicorn/ Delta V control system.

• Filtration Virus filtration and Ultrafiltration of purified product.

• Final filtration filling and finishing of purified product.

What were about:

• We are passionate about our work and play vital roles across a range of professional fields and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. We endeavor to create an environment where we:

• Display passion about doing whats right and work on own initiative.

Become familiar with daily activities in all areas of Manufacturing.

• Facilitate an environment of continuous improvement open communication collaboration and teamwork to ensure that work targets for shift are met.

• Lead investigations in work area as necessary and work as a strategic partner with cross-functional teams as necessary to support site goals.

• Support training of other Operations colleagues and new team members.

• Foster and environment of knowledge sharing across the team and continuous improvement procedures.

• Give Exposure to multiple new technologies that are shaping future biopharmaceutical industry trends.

Work in a dynamic multiproduct environment

• Provide Opportunity to work in Global cross platform initiatives and projects.

• Encourage further development through educational assistance program.

• Demonstrate values and behaviors consistent Johnson & Johnson Credo.

Be vital:

• To be part of this high performing team you will display great attention to detail alongside:

Qualification and Experience:

Required:

• Third level or equivalent qualification.

• Demonstration of leadership capabilities in previous roles.

• Understanding of the requirements of cGMP and familiarity with other relevant regulatory requirements.

Desirable:

• Scientific or Technical Qualification.

• Supervisory experience.

• Operations experience within a GMP regulated environment.

• Operations experience within a Life Sciences or Biopharmaceutical environment.

Make a unique mark in your career

• If you want to be seen for the talent you bring to your work be the driver of your own career and work with others who share your real passion for caring and success then we invite you to join the Johnson & Johnson Talent Community by visiting .

• If you decide to apply for the position any personal data which you provide shall be processed by Johnson& Johnson Medical a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment recruitment policy and selection.

• We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race religion color national origin gender sexual orientation age marital status veteran status or disability status.

Additional Information

General Scope and Responsibilities:

• Execution of Operations activities as necessary to meet operational needs to the highest operational standards.

• Prioritize and schedule activities to support business needs and to meet requirements of Master Production Schedule.

• Oversee all activities in compliance with corporate and cGMP/EHS regulatory requirements and ensuring any associated deviations are completed in a timely manner.

• Facilitation of root cause problem solving sessions to correct and prevent reoccurrence of issues. Review of documentation in compliance with site procedures and GDP.

• Ensure Operations areas are appropriately set-up to complete process steps and enforce good aseptic techniques.

• Maintenance and calibration of Operations equipment support commissioning & qualification activities and assist with generation review and revision of Operations documentation.

• Developing systems to monitor quality and efficiency of area activities and implementing continuous improvement strategies.

• Ensure effective communication occurs within the team between shift teams and with other departments.

• Provide coaching and feedback to the team and individuals to aid their learning process and help them acquire the skills necessary to perform effectively both as a team and as individuals.

• Provide a forum for training and ensure teams compliance with company standards.

• Establishing team goals that align with the organisational goals and business/operational needs.

• Measuring these goals and ensure that specific targets are met.

• Participate in regulatory audits and ensure audit readiness at all times.

• Ensure effective implementation of BEX projects Kaizen 5S Lean.

• Support of Commissioning and Qualification activities.

• Deputize for Operations manager as necessary.

Significant Environmental Health & Safety considerations: All employees are required to comply with the requirements of the companys Environmental Health & Safety Policy Safety Statement associated EHS Procedures local legislation and duties outlined in the site EHS Manual In line with the Safety Health & Welfare at Work Act (2005) all employees are required to:

• Take reasonable care to protect their own and the safety of their colleagues who may be affected by their actions.

• Comply with EHS rules and procedures at all times.

• Understand the potential EHS impact of their activities.

• Attend and participate in EHS training as required.

• Use PPE and safety equipment as required.

• Report all incidents accidents and near miss events.

IMPORTANT This position description is a general guideline for colleagues it does not purport to be an exhaustive list of all elements of the position. Management reserves the right to modify this position description at any time or to vary the duties and responsibilities of the position to meet production scheduling or other business needs.

The anticipated base pay range for this position is 63000 to 101315.

In addition to base pay we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location where the actual amount is based on the employees and companies performance of the previous calendar year or sales commissions. Moreover we offer vacation days parental leave for a minimum of 12 weeks bereavement leave caregiver leave volunteer leave well-being reimbursement and programs for financial physical and mental health. We also offer service anniversary and recognition awards and subject to the terms of their respective plans employees - and in some locations eligible dependents - can participate in several insurance plans. For more information visit Employee benefits Supporting well-being & career growth Johnson & Johnson Careers.

• This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

Required Skills:

Preferred Skills: