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.

Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

People Leader

All Job Posting Locations:

Malvern, Pennsylvania, United States of America, Spring House, Pennsylvania, United States of America

Job Description:

Johnson and Johnson Innovative Medicines, is recruiting for a Global Subject Matter Expert (SME), Advanced Therapies Quality (ATQ)( Focus on Gene Therapies and support cell therapies)

At Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Johnson and Johnson. We collaborate with the world for the health of everyone in it.

This Flexible role will have significant impact on patients who are awaiting our Innovative medicines. Enabling release of meaningful cell and gene therapies (Advanced Therapies) to patients in need will make this job very exciting! You will play a meaningful role in optimization of product testing, to enable product release. In this job, it will be essential to be a standout colleague. Sustainable relations with team members must be built and maintained. Different global partners like Analytical development, Quality assurance and External quality are important in setting up more efficient and better technologies and testing processes. You will introduce new technologies in laboratories across the globe. Next to being creative, analytical knowledge will be meaningful to perform in depth investigations. When issues occur at the laboratory or in manufacturing your expertise will be required to support investigations. Collaborating closely with QC organizations, internal as well as external, and setting up a data driven culture for investigations will be of importance. Also an high number of critical reagents must be managed and coordinated due to the complexity of Cell and Gene products. When you look forward to work in an environment which is highly exciting, in which groundbreaking products are manufactured and tested which have direct impact on patients, we are looking for you!

Job Responsibilities:

• Be a reliable source of technical support, actively assisting in secondary method transfer/validation activities for Advanced Therapy products, including but not BiCAR Products, ensuring their successful implementation.

•  Contribute to the development and review of technical protocols for advanced therapies, including exciting BiCAR related studies.

• Showcase your expertise as a representative of our global ATQ team, taking part in global laboratory initiatives.

• Harness your problem-solving skills to identify compelling opportunities for optimization in methods and technologies. Collaborate with key partners to implement innovative improvements and enhancements that propel us forward.

• Conduct insightful cost-benefit analyses and help craft compelling cases for implementing pioneering initiatives. Your contribution will influence the decision-making process and feed a culture of high-impact innovation.

• Take the lead in planning and implementing innovative technologies across our ATQ QC laboratories worldwide including in external CMOs. Your vision and expertise will be instrumental in driving continuous improvement and encouraging a ground breaking work environment.

• Embark on an exciting journey to implement COGs reduction initiatives, playing a vital role in enhancing operational efficiency and cost-effectiveness.

• Become a trusted coach and mentor, providing comprehensive guidance and coaching to technical professionals and external partners.

• Collaborating with cross-functional global teams, you will participate in root cause analysis, bringing about insightful resolutions to sophisticated challenges.

• Play a key role in site troubleshooting efforts, working closely with teams to address difficult technical issues. Your expertise and mentorship will form the backbone of our collective success

• Support compilation of and review of Global Trending data and identification of globally impacting issues. Technical support for issue resolution.

• Acts as Global QC Single point of contact (SPOC) for different departments

Experience and Skills:

Required:

• 5-10 years of related work experience

• Cell and Gene therapy product, manufacturing and analytical knowledge.

• Experience in a pharmaceutical environment and knowledge of GMP, analytical development and QC.

• Leadership sklls to lead and train teams

• Statistical experience

• Experience with project management and governance structures.

• Strong communication skills

• Able to work independently.

• Flexible and accurate

• Professional proficiency in English

Preferred:

• Process Excellence and lean tools.

Job Requirements:

• Minimum qualification: Bachelor degree or equivalent experience. Preferred Master’s degree or PhD in relevant subject area

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.

Required Skills:

 

 

Preferred Skills:

Compliance Management, Controls Compliance, Corrective and Preventive Action (CAPA), Developing Others, Econometric Models, Inclusive Leadership, ISO 9001, Leadership, Operational Excellence, Performance Measurement, Quality Control (QC), Quality Standards, Standard Operating Procedure (SOP), Strategic Thinking, Team Management, Technologically Savvy

 

 

The anticipated base pay range for this position is :

$94,000.00 - $151,800.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

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


This position is eligible to participate in the Company’s long-term incentive program.



Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation –120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year

Holiday pay, including Floating Holidays –13 days per calendar year

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

Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave – 80 hours in a 52-week rolling period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year