Principal Scientist Formulations
Location: Malvern, Pennsylvania, United States | Job Function: Discovery & Pre-Clinical/Clinical Development | Sub Function: Biotherapeutics R&D | Category: Scientific/Technology
About the role
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.
The Principal Scientist, Protein Formulations will be a lab-based role with expertise in protein science and support formulation development within the Protein Drug Product Development & Delivery (DPD&D) department. The candidate will be an experienced individual contributor able to manage or contribute to scientific projects, programs, and processes. 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, diluent compatibility/administration relevant studies and stability campaigns.
Responsibilities
- Design, execute, analyze, and document studies to develop and optimize formulations for biologic therapeutics. Studies include, but are not limited to, biophysical characterization, stability, composition selection, excipient selection, freeze/thaw, mixing, clinical administration, robustness, and development of administration protocols.
- Accurately interpret complex datasets and effectively communicate impact to stakeholders through formal and informal disclosures.
- Evaluate and develop technologies in emerging fields of drug delivery to enhance the protein portfolio.
Requirements
Education & Experience
- Ph.D. in an appropriate scientific discipline such as Biomedical Engineering, Chemical Engineering, Pharmaceutical Sciences, Biophysics, Chemistry, etc. and 3+ years of industry relevant experience
- OR MS degree with 6+ years of experience
Required Skills & Knowledge
- Strong understanding and knowledge of protein stability, thermodynamics, and biophysical techniques for characterization
- 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)
- Ability to identify protein liabilities and perform developability assessments for products from pre-clinical to commercial readiness
- Ability to interpret and analyze data from biophysical and biochemical assays and design appropriate experiments
- Technical writing skills, including the ability to maintain high-quality documentation and prepare reports, SOPs or other technical reports
- Ability to use emerging developments in drug delivery to lead new technical and research initiatives
- Capable of working with multi-disciplinary teams
Preferred Qualifications
- Understanding of regulatory pathways for large molecule therapeutics
- Experience with authoring and reviewing regulatory filings supporting IND, IMPD, BLA, or MAA
- Proven publication and presentation history and involvement with scientific organizations or conferences
Skills
Required Skills
- Analytical Reasoning
- Biochemistry
- Biotechnology
- Chemistry, Manufacturing, and Control (CMC)
- Clinical Research and Regulations
- Clinical Trial Designs
- Coaching
- Critical Thinking
- Drug Discovery Development
- Emerging Technologies
- Molecular Diagnostics
- Organizing
- Pharmacovigilance
- Presentation Design
- Process Improvements
- Productivity Planning
- Scientific Research