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**Job Function: **
Discovery & Pre-Clinical/Clinical Development
**Job Sub Function: **
Biotherapeutics R&D
Job Category:
Scientific/Technology
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 Senior Principal Scientist, Large Molecule Drug Product Scientific Integrator (Late Stage) to be located in Malvern, PA.
**Purpose: **The Senior Principal Scientist, Large Molecule Drug Product Scientific Integrator, sits in the Drug Product Development and Delivery (DPDD) organization and 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 -mAbs, multispecifics, ADCs, and RLTs.
This role provides single‑point accountability for Drug Product strategy within the global Chemistry, Manufacturing, and Control (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 practices 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 6+ years of experience in biopharmaceutical development is required OR
- Master’s degree in Pharmaceutical Sciences, Chemical Engineering, Biochemistry, or a related scientific field with 10+ years of experience in biopharmaceutical development will be considered.
Experience and Skills:
**Required: **
- Significant years of experience in large‑molecule drug product development, ranging from late‑stage, registration, and/or commercial program experience.
- 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.
- 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:
- Experience as primary Drug Product lead for at least one registered or launched biologic.
- Direct involvement in Health Authority interactions, written responses, and inspection support.
- Experience with post‑approval change management and lifecycle optimization.
- 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.
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**Required Skills: **
Preferred Skills:
Analytical Reasoning, Biochemistry, Biotechnology, Chemistry, Manufacturing, and Control (CMC), Clinical Research and Regulations, Clinical Trial Designs, Collaboration, Data Synthesis, Drug Discovery Development, Molecular Diagnostics, Pharmacovigilance, Process Improvements, Productivity Planning, Program Management, Scientific Research, Tactical Planning, Technical Credibility