Sr Supv Quality Control

Johnson & Johnson Innovative Medicine•Malvern, PA

About The Position

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!

Requirements

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
Minimum qualification: Bachelor degree or equivalent experience.

Nice To Haves

Process Excellence and lean tools.
Preferred Master’s degree or PhD in relevant subject area

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

Benefits

employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year