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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, Biologics Analytical Development, Comparability to be located in Malvern, PA.
 

Purpose: The Therapeutics Development and Supply, Protein Development, Analytical Development organization is recruiting a highly skilled and motivated Director to join our Protein Analytical Development Characterization group. The role reports to the Senior Director of Analytical Development Characterization and will lead a group focusing on analytical comparability studies of protein biologics (monoclonal antibodies, bispecifics, multispecifics, antibody drug conjugates, fusion proteins, and other therapeutic proteins).
 

This role is critical in driving the development and execution of innovative and phase-appropriate analytical comparability strategies during early and late clinical development and commercialization, ensuring the successful advancement of our innovative therapies through global regulatory filings.
 

You will be responsible for:

• Leading a team of 10 scientists delivering analytical comparability studies for proteins and protein conjugates, ensuring robust comparability strategy development, study execution, and regulatory filings aligned with global health authority expectations.
   
• Applying deep expertise in protein characterization to conduct comprehensive risk assessments of the potential impact of quality attribute differences (e.g., glycosylation, charge variants, PTMs, etc.) on efficacy, pharmacokinetic, safety, and immunogenicity following process or product changes.
   
• Collaborating and communicating across CMC, API, Drug Product & Device, Therapeutic Discovery, Regulatory Affairs, Preclinical Sciences & Translational Safety, Clinical Pharmacology and clinical teams to lead or provide input on comparability requirements during cross-functional strategy reviews.
   
• Authoring and reviewing comparability protocols, reports, and related sections and contribute to IND/CTA/BLA/MAA submissions to meet global health authority expectations.
   
• Authoring and reviewing Briefing Books and participate in health authority scientific advice meetings to shape comparability strategies and seek alignment.
   
• Mentoring and retain a high-performing analytical comparability team, fostering a culture of collaboration, scientific rigor, and continuous improvement.
   
• Promoting professional development through training and mentoring, ensuring team members are equipped with the necessary skills and knowledge to excel in their roles.
   

Qualifications / Requirements

Education:

• A PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field is required.
   

Experience and Skills:

• A minimum of 10 years of relevant industry experience in analytical developmen