ESSENTIAL FUNCTIONS:

• Build and manage a highly engaged world-class site MSAT team providing strategic leadership and direction aligned with the site and Advanced Therapies network.

• Single Point of Contact (SPOC) for Site MSAT needs for CARVYTKI, responsible for managing MSAT team's contribution towards manufacturing floor support, investigations of major/critical process deviations, impact assessments, process monitoring/continued process verification, MSAT laboratory studies supporting investigations/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 that advances the CARVYKTI platform.

• Proactively promotes compliance, safety, and quality and creates an environment where speaking up and reconciling issues is expected and coaches others to do the same.

• Proactively seeks out, establishes, and sustains a broad set of diverse relationships based on respect within and outside of J&J and holds self and others accountable to do the same.

• Oversee a team serving as the site technical leads for site process technology transfer (in/out) including process qualification/comparability campaigns, process risk assessments, process control strategies and new process training.

• Responsible for oversite, technical support, tracking, and resolution of site investigations, including communication to management.

• Oversee technical support to regulatory filings, regulatory inspections, and health authority questions.

• In collaboration with other functions on site, implement and maintain fit-for-purpose effective systems and business processes to assure compliance to corporate guidelines for Deviation Investigations, Technology Transfer, Capacity scaling, Process Monitoring, Raw Material Qualification, and other relevant areas.

• Planning, execution, and coordination of activities for process monitoring and process data analysis, troubleshooting, facility fit assessments of new processes into the existing manufacturing plant, assessments and writing of technical documents and technical optimization/implementation projects, including experiments conducted both at lab and pilot scale.

• Collaboration in technology transfer projects supporting implementation of new processes in manufacturing operations.

• Creates an environment where others feel comfortable in identifying new ways of working, taking bold action with sense of urgency, and celebrates and rewards those who take calculated risks, learn from mistakes, and make informed decisions.

• Proactively takes action to maximize the professional and personal development of self and others in alignment with business needs.

• Own setting team and individual objectives to meet departmental, business unit, and company objectives, contributing to the wider strategy.

• Identify and conduct performance management activities to ensure behaviors and performance of team meet required expectations, providing training and/or relevant support where needed.

*This is not an exhaustive or comprehensive listing of job functions. May perform other duties as assigned.

AUTONOMY AND COMPLEXITY:

• Lead the platform/product for delivery of site wide/global projects as required.

• Lead troubleshooting of routine manufacturing processes.

• Endlessly curious, seeking to understand the "why" behind complex scientific topics

• Develop, lead and influence implementation of innovative solutions to ensure competitiveness, product quality and process capability improvements

• Can-do mentality, agility & high flexibility able to work with stretched goals and deadlines

Qualifications

• University/Bachelors Degree in Science/Engineering or Equivalent with 10+ Years Biotech/ Pharmaceutical experience or equivalent industry experience OR Masters/PhD degree in Engineering, with 7+ years Biotech/ Pharmaceutical experience or equivalent industry experience

Required:

• Hands-on experience in Manufacturing Operation and/or R&D in a biopharmaceutical manufacturing setting (i.e. cell/gene therapy products, vaccines, or any other advanced therapy products)

• Experience leading the coordination of tech transfer activities and technical services for cell/gene therapies

• Experience working with contract partners and internal manufacturing sites

• Expert knowledge of cell and gene manufacturing processes

• Expert knowledge of GMP/quality considerations for commercial manufacturing

• Expert knowledge of evolving ATMP health authority expectations/regulations

• Expert knowledge of data analytics/sciences and process automation

OTHER SKILLS, ABILITIES OR QUALIFICATIONS:

• Works in an international environment across different time zones

• This role is based in Raritan, NJ and may require travel up to 20% - project dependent

• Knowledge of Data Analytics/Statistical Analysis Tools

The anticipated base pay range for this position is $142,000 to $244,950.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k).

Employees are eligible for the following time off benefits:

• Vacation - up to 120 hours per calendar year.

• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year.

• Holiday pay, including Floating Holidays - up to 13 days per calendar year.

• Work, Personal and Family Time - up to 40 hours per calendar year.

Additional information can be found through the link below.

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits.

This job posting is anticipated to close on 06/29/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

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.