Principal Scientist - Protein Formulation & Biophysical Characterization; -Concentration Bi Job Andover area,Massachusetts USA

Position: Principal Scientist - Protein Formulation & Biophysical Characterization (High-Concentration Bi[...]

Principal Scientist – Protein Formulation & Biophysical Characterization (High-Concentration Biologics) is a hands‑on, laboratory‑focused, scientific leadership role within a biologics and vaccines formulation group (DPDD-PhRD). The role focuses on developing and implementing novel formulation strategies and platform approaches to enable high‑dose, patient‑centric biologic delivery, including subcutaneous administration.

Key Responsibilities

Formulation Science & Characterization – Design and execute experimental studies to develop and optimize protein formulations across biologic modalities (e.g., mAbs, fusion proteins, bispecifics, antibody‑drug conjugates, peptides, etc.) in liquid and lyophilized dosage forms. Apply biophysical and physicochemical characterization to assess and mitigate key risks (aggregation, viscosity, stability). Analyze data, generate clear insights, and communicate findings to scientific teams.

Innovation & Technology Development – Develop and advance novel formulation strategies and enabling technologies for high‑concentration biologics. Build scalable approaches such as experimental workflows, screening methods, and predictive tools that can be applied across programs. Collaborate with cross‑functional teams to implement and integrate new technologies.

External Scientific Engagement – Build collaborations with academic and industry partners to advance formulation science. Contribute to external scientific visibility through publications, conference presentations, and participation in industry consortia.

Cross‑Functional Contribution – Collaborate with the internal Device Center of Excellence to facilitate optimal device selection, serving as a liaison and technical subject‑matter expert on formulation matters. Provide formulation expertise to project teams and support key development decisions. Contribute scientific input to regulatory documentation as needed.

Technical Leadership – Lead a cross‑functional group focused on subcutaneous delivery of biologics. Align with key stakeholders and devise and implement strategies to advance the biologics portfolio. Lead focused technical initiatives or platform problems; prior experience with formal project leadership is preferred but not required.

Education & Experience

PhD in Pharmaceutics, Pharmaceutical Sciences, Biophysical Sciences, Biochemistry, Chemistry, Biomedical or Chemical Engineering, or related disciplines with 3–5 years relevant experience in biologics formulation, biophysics, or drug product development (industry experience preferred). Demonstrated scientific output (e.g., publications and/or conference presentations) preferred.

Must Have

Strong background in protein formulation for parenteral biologics.
Direct hands‑on experience with biophysical/analytical characterization techniques and data interpretation, including proficiency with a broad suite of techniques (DLS, DSC, DSF, SEC‑MALS, NTA, CD, FTIR, fluorescence spectroscopy, rheology); ability to design and interpret multi‑technique characterization studies.
Familiarity with parenteral dosage forms and delivery considerations.
Ability to analyze complex data and communicate clear, actionable insights.

Nice to Have

Demonstrated expertise in protein design/engineering principles, structure‑function relationship, identification of develop ability hot spots, and how molecular attributes influence formulation behavior.
Deep understanding of challenges at elevated protein concentrations: viscosity, self‑association, aggregation, LLPS, colloidal instability, opalescence; familiarity with interaction parameters (kD, B22).
Knowledge of subcutaneous drug delivery fundamentals: injection volume/concentration constraints, tissue interactions, injectability, bioavailability considerations, container‑closure compatibility.

Optional Technical Skills

Experience with formulation of oligonucleotides, peptides, or other non‑mAb modalities.
Experience with molecular modeling, molecular dynamics simulations, machine learning/AI approaches for formulation or protein behavior prediction, QSPR modeling.

Physical/Mental Requirements

Job involves lab‑work and requires strong ability to perform…