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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:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Biotherapeutics R&D

Job Category:

People Leader

All Job Posting Locations:

Malvern, Pennsylvania, 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 a Scientific Director to be in Malvern, PA.

Purpose: The purpose of this role is to lead a team of experienced scientific integrators and serve as a key strategic and technical leader within Drug Product Development and Delivery (DPD&D).

You will be responsible for:

• a group (3-8 people) of experienced scientific integrators working as matrix leaders on highly complex CMC programs

• guiding and providing project support within the team and across the portfolio with active membership in DPD&D and cross functional governance bodies

• supporting the DPD&D innovation governance and framework led within the team

• serving as the business owner in DPD&D for best product and process at launch strategy in collaboration with E2E stakeholders while integrating customer centricity into the process

• serving as strategic leader for late development including IND/BLA reviewer for DPD&D

• proactively developing cross-portfolio technical strategies with highest business impact

• providing guidance at functional governance and support the leadership team in determining risks and mitigations

• highly complex late development programs/platforms

Qualifications / Requirements:

• PhD in Pharmacy, Pharmaceutical Sciences, Chemical Engineering or equivalent with 10+ years of experience is required

• Significant expertise in end-to-end CMC development including biopharmaceutical Dosage Forms, Drug Delivery systems and the overall drug development process including technology transfer is required

• Experience in early stage, late stage, and lifecycle management large molecule drug product and manufacturing process experience but not limited to the following: Monoclonal antibodies, bispecific antibodies, and/or ADCs is required

• Expert in ICH regulatory guidelines is required

• IND/IMPD, BLA/MAA, and sBLA/Type II variation review/approval experience for biologics is required

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.

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