Scientist I, Formulation Development
$127,300–$140,700 year
HybridSan Diego, California, United States
Job Summary
Design and conduct formulation stability studies for mAb and AOC liquid and lyophilized dosage forms, including in-use compatibility assessments for intravenous and subcutaneous routes. Perform developability assessments of early-stage protein biologics using predictive analytical and biophysical methods, while managing laboratory inventory, instrument maintenance, and vendor troubleshooting. Execute routine tasks such as buffer preparation, data processing, and technical report writing within an electronic notebook, and present findings at cross-functional meetings. This role supports the clinical and commercial formulation development of Antibody Oligonucleotide Conjugates (AOCs) at Avidity's San Diego site, focusing on improving delivery for rare muscle diseases like DMD and FSHD.
Required Qualifications
- A PhD in chemistry, biology, pharmaceutical sciences, or a related field
- An in-depth understanding of protein physicochemical stability, particularly how solvent conditions and cosolutes impact protein colloidal, conformational and chemical stabilities
- Hands-on experience with a variety of analytical methods including SEC, IEX, RP-HPLC, CE-SDS, cIEF and subvisible particle analysis
- Experience using a variety of biophysical methods for characterizing and measuring conformational and colloidal stability of protein biologics including differential scanning calorimetry, dynamic and static light scattering techniques
- Ability to design, implement and analyze formulation studies using a one-factor at a time and design of experiment (DOE) approaches using JMP statistical software or similar
- Ability to multi-task and work in a fast-paced cross-functional matrix environment
- Demonstrated excellent communication (oral and written), teamwork, organizational, interpersonal, and problem-solving skills
- Master's degree with 5 and 10 years industry experience, respectively
Desired Qualifications
- Experience in formulation development and stability testing of protein biologics, particularly for mAbs and antibody-drug conjugates (ADCs)
- Familiarity with mass spectrometry (MS) methods used for assessing mAb chemical stability and assessing ADC drug to antibody ratios including intact, reduced, and peptide mapping LC/MS
- Prior experience in lyophilization formulation, cycle development, and analytical testing
- Experience in oligonucleotide chemistry and characterization methods
- Experience working with external CMOs and CROs
- Previous experience managing direct reports
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