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We are searching for the best talent for a Director, Advanced Therapies Characterization to be in Malvern, PA.

Purpose:

The Director of Advanced Therapies Characterization will join our Advanced Therapies Analytical Development leadership team and will work with colleagues within the biologics analytical development group, focusing on advanced therapy modalities - specifically cell and gene therapy. This role is critical in driving the development and execution of innovative analytical comparability and product characterization strategies, ensuring the successful advancement of our innovative therapies through global regulatory filings.

Responsibilities:

• Lead and manage a team of scientists focused on analytical comparability and product characterization for advanced therapy modalities, ensuring robust strategy development in alignment with statistical rigor and global health authority expectations
• Collaborate to define and implement strategic goals for the analytical development group, emphasizing adaptability and responsiveness to industry and regulatory trends.
• Oversee the ideation, development, and implementation of advanced analytical methodologies associated with comparability and deep characterization of cell and gene therapy products.
• Provide scientific expertise to guide the design of experiments and analytical characterization plans, ensuring compliance with regulatory requirements and leveraging deep scientific expertise in cell therapy manufacturing
• Build, mentor, and retain a high-performing analytical team, fostering a culture of collaboration, innovation, and continuous improvement.
• Promote professional development through training and mentoring, ensuring team members are equipped with the necessary skills and knowledge to excel in their roles.
• Collaborate cross-functionally with R& D, quality assurance, regulatory affairs, and manufacturing teams to integrate analytical strategies within the broader development processes.
• Communicate complex technical concepts clearly to a variety of stakeholders, including senior management and regulatory agencies.
• Navigate the complexities of a dynamic scientific environment by implementing effective change management strategies that promote agility and responsiveness within the team.
• Foster an environment that embraces innovation, encouraging team members to explore novel analytical approaches in a structured, translational approach

Qualifications:

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related field with a minimum of 6 years of relevant industry experience in analytical development, specifically with advanced therapy modalities such as cell and gene therapies; OR a BS or MS with 10-12 years of overall work experience is required.
• In-depth knowledge of regulatory requirements and industry best practices related to analytical comparability and product characterization is required.
• Demonstrated experience in IND and BLA filings is required.
• Strong people leadership, communication, and interpersonal skills with a proven ability to influence stakeholders and drive collaborative efforts is required.
• Travel may be required up to 25% of the time.

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 veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and 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 (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.