Senior Scientist, Protein Formulations

Johnson & Johnson•Malvern, PA

21h•Onsite

About The Position

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 Scientist, Protein Formulation to be located in Malvern, PA. Purpose: Drug Product Development and Delivery (DPD&D) is responsible for formulation, process, device development, and clinical manufacturing of biotherapeutics. The Senior Scientist position within Protein Formulations group in DPD&D will be a lab-based role, responsible for experimental studies in pre-formulation, formulation, and analytical development of therapeutic proteins (mAbs, bispecifics and multispecifics) as well as bioconjugates. This includes development and optimization of the technical operations associated with biologics development, high concentration feasibility, excipient screening, diluent compatibility/administration assessment, and stability campaigns. The scientist will work independently as well as with cross-functional teams to support project needs and meet project deliverables.

Requirements

PhD in Biophysics, Chemistry, Pharmaceutical Sciences, or a related scientific field with 2+ years of experience in academia or biopharmaceutical industry, or Masters’ degree with 4+ years of relevant pharmaceutical experience or a Bachelor's degree with 6+ years of relevant pharmaceutical experience is required.
Knowledge and experience in protein biophysics and biophysical characterization is required.
Working knowledge of bioconjugates, various conjugation chemistries (random, site-specific, enzymatic), small molecules, and linkers and payloads is required.
Expertise in biochemical, biophysical and/or analytical methodologies such as HPLC, spectroscopy (e.g. UV, IR, Raman), light scattering (e.g. SLS, DLS), particle analyzers (e.g. MFI, HIAC), and separation methods (e.g. CEX, cIEF, HIC) are required.
Ability to design appropriate experiments and interpret and analyze complex data from biophysical assays is required.
Ability to maintain laboratory notebooks in compliance with Good Laboratory/Manufacturing Practices is required.

Nice To Haves

Experience in biotherapeutics formulation development is preferred.
Knowledge of LC/MS characterization of large and small molecules is preferred.
Understanding of regulatory pathways for biotherapeutics.
Experience with authoring and reviewing regulatory filings (e.g. IND, IMPD, BLA, MAA) is preferred.
Publication and presentation history and involvement with scientific organizations or conferences is preferred.

Responsibilities

Designing and performing formulation screening, characterization, and stability studies to support early and late-stage product development.
Developing and implementing chromatographic, biophysical, and analytical methods to characterize structural attributes, stability, and degradation mechanisms of bioconjugates and their individual components (e.g., linker, payload, antibody).
Collaborating with Discovery and Development teams to identify molecule and formulation related challenges in protein and bioconjugate development and develop appropriate drug product presentation and risk mitigation strategies.
Collecting, analyzing, interpreting, and documenting experimental data, and communicating the results effectively to project teams, cross-functional partners, and senior leadership.
Authoring and reviewing technical documentation, including study protocols, technical reports, and technology transfer documents to support drug product manufacturing.
Serving as a subject matter expert and team representative on cross-functional team.