Principal Scientist, Large Molecule Drug Product Scientific Integrator Full-time

Principal Scientist, Large Molecule Drug Product Scientific Integrator (Late Stage)

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.

We 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 end-to-end scientific integration for one or more late-stage (Phase2/3, registration, launch, and lifecycle) large-molecule drug product programs.

This role provides single-point 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 right-first-time registration, launch readiness, and lifecycle success, acting as a trusted scientific advisor and matrix leader across global teams.

You will be responsible for:

• Acting as the primary Drug Product scientific lead for assigned late-stage large-molecule programs, owning the integrated drug product strategy from registration through lifecycle management.
• Leading cross-functional drug product sub-teams 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 post-approval change planning.
• Authoring, reviewing, and approving drug product sections of global regulatory submissions, including BLA/MAA and post-approval 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 cross-functional challenges.
• Mentoring and coaching scientists, fostering strong scientific judgment, collaboration, and capability development.
• Contributing to organizational best methods and continuous improvement in late-stage drug product development and integration.

Qualifications/Requirements

Education:

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

Experience and Skills:

Required:

• Experience in large-molecule drug product development, ranging from late-stage 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 post-approval 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 decision-making capability.

Preferred:

• Direct involvement in Health Authority interactions, written responses, and inspection support.
• Familiarity with complex delivery systems, low-dose products, or challenging administration scenarios.
• Track record of mentoring scientists and building cross-program scientific capabilities.

Other:

• Willingness to travel approximately 10–20%, 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 https://www.jnj.com/contact-us/careers, 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 parent's consent for the background check.

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Required Skills: Analytical Reasoning, Biochemistry, Biotechnology, Chemistry, Manufacturing, and Control (CMC), Clinical Research and Regulations, Clinical Trial Designs, Coaching, Critical Thinking, Drug Discovery Development, Emerging Technologies, Molecular Diagnostics, Organizing, Pharmacovigilance, Presentation Design, Process Improvements, Productivity Planning, Scientific Research