Principal Scientist, Large Molecule Drug Product Scientific Integrator

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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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 are searching for the best talent for a Principal Scientist Large Molecule Drug Product Scientific Integrator (Late Stage) to be located in Malvern PA.

Purpose: The Principal Scientist Drug Product Development and Delivery (DPD&D) Scientific Integrator is responsible for endtoend scientific integration for one or more latestage (Phase2/3 registration launch and lifecycle) largemolecule drug product programs.

This role provides singlepoint accountability for Drug Product strategy within the global CMC team/s ensuring alignment across formulation process delivery system analytical manufacturing quality regulatory and supply chain functions. The Scientific Integrator plays a critical role in rightfirsttime registration launch readiness and lifecycle success acting as a trusted scientific advisor and matrix leader across global teams.

• Acting as the primary Drug Product scientific lead for assigned latestage largemolecule programs owning the integrated drug product strategy from registration through lifecycle management.
  
• Leading crossfunctional drug product subteams and representing drug product on global CMC teams.
  
• Aligning formulation manufacturing process analytical strategy delivery system quality regulatory and supply considerations into a cohesive and executable plan.
  
• Defining and maintaining drug product CMC strategy including control strategy critical quality attributes comparability and postapproval change planning.
  
• Authoring reviewing and approving drug product sections of global regulatory submissions including BLA/MAA and postapproval filings.
  
• Partnering with manufacturing sites to support technology transfer process validation launch readiness and lifecycle improvements.
  
• Leading scientific risk assessment and resolution of complex technical and crossfunctional challenges.
  
• Mentoring and coaching scientists fostering strong scientific judgment collaboration and capability development.
  
• Contributing to organizational best methods and continuous improvement in latestage drug product development and integration.
  

Education:

• PhD in Pharmaceutical Sciences Chemical Engineering Biochemistry or a related scientific field with 4 years of experience in biopharmaceutical development is required; OR
  
• Masters degree in Pharmaceutical Sciences Chemical Engineering Biochemistry or a related scientific field with 6 years of experience in biopharmaceutical development will be considered.
  

Required:

• Experience in largemolecule drug product development ranging from latestage to registration.
  
• Proven experience leading Drug Product strategy on global CMC teams for parenteral biologics (liquid and/or lyophilized).
  
• Strong background in CMC regulatory strategy including authoring and reviewing IND/IMPD BLA/MAA sBLA and postapproval submissions.
  
• Demonstrated expertise in control strategy development criticality assessments comparability and lifecycle management.
  
• Experience partnering with manufacturing sites to support technology transfer process validation investigations and inspections.
  
• Experience with pharmacy manual studies and responding to clinical site questions on investigational preparation (IP) preparation.
  
• Ability to influence align and lead through matrix teams across functions and regions.
  
• Excellent written and verbal communication skills with strong scientific judgment and decisionmaking capability.
  

• Direct involvement in Health Authority interactions written responses and inspection support.
  
• Familiarity with complex delivery systems lowdose products or challenging administration scenarios.
  
• Track record of mentoring scientists and building crossprogram scientific capabilities.
  

• Willingness to travel approximately 1020% including domestic and international travel to support development and manufacturing activities.
  

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 & 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 external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment as well as get a parents consent for the background check.

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