Principal Scientist, Large Molecule Drug Product Scientific Integrator

Johnson & Johnson Innovative Medicine•Malvern, PA

2d•Onsite

About The Position

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 jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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 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.

Requirements

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 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.

Nice To Haves

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.

Responsibilities

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.