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 https://www.jnj.com
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.
We are searching for the best talent for a Principal Scientist, Formulations to be located in Malvern, PA.
Purpose: The Principal Scientist in the Drug Product Development & Delivery will be a lab-based role with expertise in protein science and support formulation development. The candidate will be an experienced individual contributor able to manage or contribute to scientific projects, programs, and processes. They will be responsible for the design and execution of experimental studies in pre-formulation, formulation and biophysical characterization of therapeutic proteins or other biologics including monoclonal antibodies (mAbs), multi-specifics, fusion proteins, and mixed conjugates. This includes development and optimization of the technical operations associated with liquid and lyophilized biologics development, diluent compatibility/administration relevant studies and stability campaigns.
You will be responsible for:
* Designing, completing, analyzing, and documenting studies to develop and optimize formulations for biologic therapeutics. Studies include, but are not limited to, biophysical characterization, stability, composition selection, robustness, and development of administration protocols.
* Planning, conducting, evaluating, and recording studies to support formulation selection and manufacturing unit operations including stability and excipient selection, freeze/thaw, and mixing.
* Designing, completing, analyzing, and documenting compatibility studies to support administration of biologic therapeutics.
* Clearly and effectively communicating plans, results, and decisions to key partners and broader team.
* Accurately interpreting complex datasets and effectively communicating impact through formal and informal disclosures.
* Developing technologies and using new developments in emerging fields to improve processes, formulations, drug delivery strategies and generate innovative research ideas.
Qualifications / Requirements:
Education:
* A minimum of a Bachelor's degree with 6+ years of relevant experience (in an appropriate scientific field such as Biomedical engineering, Chemical Engineering, Pharmaceutical Sciences, Biophysics, Chemistry, etc.) is required.
* An advanced degree (Master's degree with 4+ years or PhD with 2+ years of relevant experience) is preferred.
Experience and Skills:
Required:
* Technical writing skills, including the ability to maintain high quality documentation and prepare reports, SOPs or other technical reports is required.
* Ability to use emerging developments in relevant scientific fields to support new technical and research initiatives is required.
Preferred:
* A strong understanding and knowledge of protein stability, thermodynamics, and biophysical techniques for characterization is preferred.
* Experience with protein biophysical characterization and chromatography techniques such as HPLC, fluorescence and UV spectroscopy, light scattering (e.g. SLS, DLS), particle analysis (e.g. MFI, HIAC), and separation methods (e.g. CEX, cIEF, HIC) is preferred.
* Ability to identify protein liabilities and perform developability assessments for products from pre-clinical to commercial readiness is preferred.
* Ability to interpret and analyze data from biophysical and biochemical assays and design appropriate experiments is preferred.
* Experience in protein formulation and drug product development including high throughput screening, biophysical characterization, computational modeling and advanced data analytics is preferred.
* Understanding of regulatory pathways for large molecule therapeutics is preferred.
* Experience with authoring and reviewing regulatory filings supporting IND, IMPD, BLA, or MAA is preferred.
* Proven publication and presentation history and involvement with scientific organizations or conferences is preferred.
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