Associate Director

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 https://www.jnj.com

Job Function:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

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 https://www.jnj.com/innovative-medicine

We are searching for the best talent for an Associate Director, MSAT (Advanced Therapies) based in Raritan, NJ, Spring House, PA or Malvern, PA.

Purpose:

Johnson and Johnson Innovative Medicines is recruiting for the Manufacturing Science and Technology organization!  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. Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our cell therapy products? Apply today for this exciting opportunity to be part of the team!

The Associate Director serves as part of the Global Technical Team, reporting to the Director, MSAT LCM within the Advanced Therapies Manufacturing Science and Technology Organization.  They are the single point of contact at the manufacturing site for the technical team, responsible for driving implementation of key initiatives related to the product technical roadmap and lifecycle management plan for the Advanced Therapies Supply Chain portfolio of products.  Example focus areas include projects that will drive reliability, innovation and sustainability in our processes and plants, both internally and externally. Cross-functional partnership with R&D, Quality, and Regulatory will be required to ensure processes meet the needs of today and tomorrow.

You will be responsible for:

• Partner cross-functionally across the MSAT organization and site operations, owning the coordination of all technical activities at the contract manufacturer.

• Provide technical leadership and strategic direction for manufacturing processes, ensuring scalability and robustness.

• Lead the development of technical, quality, & compliance risk assessments/mitigation strategies and possible business continuity plans

• Proactively monitor technical process and product performance to detect trends and develop mitigation plans.

• Collaborate closely with R&D, Quality, Regulatory, and Manufacturing teams to identify and resolve technical challenges.

• Reviews technical product & process risk profiles and criticality analysis

• Develop and implement manufacturing process improvements, validation strategies, and troubleshooting plans.

• Support regulatory filings by preparing technical documentation and responding to agency inquiries.

• Drive innovation by evaluating new manufacturing technologies, equipment, and methodologies.

• Ensure compliance with cGMP regulations, safety standards, and corporate policies.

• Interface with the CMO leadership to align on project timelines, budgets, and quality expectations.

• Contribute to the development of the long-term supply strategy including scenario development and E2E impact analysis

• Collaborate with R&D, site functions and finance to identify COGS improvement opportunities (COGS optimization process)

• Lead improvement/innovation opportunities, to build project business cases and to prioritize projects (product related)

• Democratize process information across sites

• Author “why” modules and train operations/quality on scientific basis of the process

• Support failure investigations (escalation of quality or compliance events)

• Execute or follow-up on execution of technical projects

• Present to health authorities during inspections

• Develop validation approaches and technical strategy for implementation of key initiatives

• Identify and oversee implementation (in partnership with DPDS) of lifecycle management, new technology and automation projects at the manufacturing sites to improve robustness, scalability and cost/cycle time/quality performance for approved products

• Partner cross-functionally and champion to develop strategies for comparability exercises to enable change implementation.

• Ensure technical and manufacturing product requirements are addressed throughout lifecycle of new solutions

• Author and review technical reports, source documentation and filing sections to support product lifecycle and regulatory submissions

• Create, maintain, and upgrade product technical knowledge as an element of the value chain knowledge infrastructure

• Perform internal and external benchmarking activities.

AUTONOMY AND COMPLEXITY:

• Represent the area for 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:

• A Bachelor’s Degree in Science/Engineering or Equivalent with 8-10 Years Biotech/ Pharmaceutical experience or equivalent industry experience; OR a Masters/PhD degree in Engineering, with 4-6 years Biotech/ Pharmaceutical experience or equivalent industry experience

• Hands-on experience in Manufacturing Operation and/or R&D in a biopharmaceutical manufacturing setting (ie. 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

• 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

• Works in an international environment across different time zones

• Travel: up to 20% - project dependent

• Knowledge of Data Analytics/Statistical Analysis Tools

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 vertebras 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, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$120,000 to $207,000

Additional Description for Pay Transparency:

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: o Vacation – up to 120 hours per calendar year o 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 o Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year · Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.