Senior Scientist, Protein Formulations Full-time

Senior Scientist, Protein Formulation

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Job Function: Discovery & Pre-Clinical/Clinical Development

Job Sub Function: Biotherapeutics R&D

Job Category: Scientific/Technology

Location: Malvern, Pennsylvania, United States of America

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.

You will be responsible for:

• 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.

Qualifications/Requirements

Education:

• 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.

Experience and Skills:

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.

Preferred:

• 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.

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 careers link, internal employees contact AskGS to be directed to your accommodation resource.