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, Spring House, Pennsylvania, United States of America
Job Description:About Innovative MedicineOur 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, Biologics Discovery Process Research (BDPR) Integrator - Protein Expression and Scale-Up to be located in Spring House, PA or Malvern, PA.Purpose: The Senior Principal Scientist, BDPR Integrator will serve as a cross-functional integrator within Biologics Discovery Process Research, connecting Discovery, Therapeutic Development & Supply (TDS), Chemistry, Manufacturing and Controls (CMC), and process development teams to advance biologics programs from discovery through early development. The role will provide integrative technical leadership grounded in mammalian expression, cell line development, and scale-up expertise, ensuring that expression feasibility, manufacturability, productivity, product quality, and scalable production considerations are incorporated into molecule selection, material supply planning, and program strategy.
The preferred candidate is not only a deep technical expert in mammalian expression systems, stable cell line development, clone selection, and upstream process scale-up, but also an effective integrator who can translate technical data into development recommendations, align partners across functions, and proactively identify risks that could impact downstream development or CMC readiness.
You will be responsible for: - Serving as the TDS scientific integrator on Discovery project teams, aligning strategy, data expectations, and technical risk assessment across Discovery and Development.
- Ensuring mammalian expression, cell line development, manufacturability, and scale-up considerations are incorporated into discovery and early development decisions.
- Connecting Discovery, TDS, CMC, and process development teams to align technical expectations, material supply strategies, data packages, and development readiness criteria.
- Providing expert input on mammalian expression system selection, transient and stable expression approaches, vector and host cell considerations, clone screening, productivity, product quality, and manufacturability.
- Designing, interpreting, and integrating studies that assess expression feasibility, cell line performance, upstream process robustness, and early scale-up risk to support molecule selection and program strategy.
- Identifying and communicating technical risks related to low productivity, poor product quality, cell line instability, material supply constraints, scale-up limitations, and manufacturability challenges.
- Translating complex technical findings into clear recommendations, mitigation plans, and decision-enabling narratives for program teams, governance forums, and cross-functional partners.
Qualifications/RequirementsEducation:- PhD in Cell Biology, Molecular Biology, Biochemistry, Chemistry, Biomedical Engineering, Biotechnology or a closely related field is required.
Experience and Skills:Required: - A minimum of 10 years of biopharmaceutical R&D experience with significant focus on mammalian expression, stable cell line development, upstream process development, and biologics development integration.
- Deep technical expertise in mammalian expression systems, including CHO or other relevant host cell platforms, vector design considerations, transient and stable expression, clone generation, clone screening, and cell line characterization.
- Demonstrated experience connecting small-scale expression, clone selection, and early process development data to scale-up strategies and development-relevant bioreactor systems.
- Strong understanding of how expression performance, cell line attributes, upstream process conditions, productivity, product quality, and manufacturability influence biologics CMC strategy.
- Proven ability to operate as a cross-functional integrator, influence without authority, manage complex partner groups, and align technical teams around program decisions.
- Excellent communication, interpersonal, and scientific storytelling skills, with the ability to translate technical complexity into clear recommendations for senior and cross-functional audiences.
Preferred:- Experience serving in a program integrator, technical lead, or cross-functional liaison role across discovery, process development, and CMC interfaces.
- Experience supporting IND-enabling or early clinical development efforts, including cell line readiness, process scale-up, and process transfer activities.
- Familiarity with high-throughput expression screening, automation, platform cell line development workflows, or data-driven clone selection approaches.
- Experience with complex biologic formats, including bispecifics, multispecifics, fusion proteins, or difficult-to-express molecules.
- Experience working across global teams or in high-complexity program environments.
#LI-Hybrid
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
