Senior Scientist, Formulations Full-time NEW

Senior Scientist, Formulations

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 Senior Scientist, Formulations, located in Malvern, PA.

Purpose: The Senior Scientist, Formulations will be a lab-based role with expertise in formulation science to support the development of protein formulations. The candidate 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 biologics development, high concentration feasibility, surfactant selection, diluent compatibility/administration assessment, and stability campaigns.

You will be responsible for:

• Devise and implement formulation and drug product presentation strategies to support all phases of clinical and commercial development
• Lead protein programs as a scientific integrator in early development
• Support late phase protein programs by leading formulation activities
• Design and execute studies to characterize, optimize, and demonstrate the stability of protein formulations through manufacturing, storage, transportation, and administration
• Provide subject matter expertise in interactions with health authorities, including authoring CTD granules, participating in meetings, and responding to questions

Qualifications / Requirements:

Education: We are looking for a Ph.D. graduate or a candidate holding their bachelors and/or masters degree with minimum 4 years' experience (academia/research/intern/co-ops counts towards experience). Degrees will be in an appropriate scientific field such as Chemical Engineering, Pharmaceutical Sciences, Biophysics, Chemistry, Bioengineering, etc.

Experience and Skills Required:

• Experience in the fields of colloidal stability, rheology, tensiometry, and fluid dynamics
• Ability to design and execute experiments, analyze data, and interpret results
• Technical writing skills, including the ability to maintain high quality documentation and prepare SOPs or other technical reports
• Ability to use emerging developments in relevant scientific fields to support new technical and research initiatives
• Communication and collaboration skills to both lead and work with teams
• Capability to learn and navigate problems with a high degree of independence

Preferred:

• Knowledge of and experience with protein biophysical characterization techniques
• Understanding of regulatory pathways for biotherapeutics. Experience with authoring and reviewing regulatory filings (e.g. IND, IMPD, BLA, MAA)
• Publication and presentation history and involvement with scientific organizations or conferences

Required Skills: Analytical Reasoning, Biochemistry, Chemistry, Manufacturing, and Control (CMC), Coaching, Consulting, Critical Thinking, Drug Discovery Development, Emerging Technologies, Molecular Diagnostics, Pharmacogenetics, Pharmacovigilance, Process Improvements, Quality Assurance (QA), Relationship Building, Research Documents, Scientific Research, Technologically Savvy