Scientist I, Formulation Development

About the role

Avidity Biosciences is revolutionizing the field of RNA with its proprietary AOCs, designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies. This role focuses on the clinical and commercial formulation development of AOC drug product and drug substance.

Responsibilities

• Design and work with TD&O team members to set up and conduct formulation stability studies of mAb and AOC liquid and lyophilized dosage forms
• Conduct in-use compatibility studies of AOC drug products intended for intravenous and subcutaneous routes of administration
• Perform developability assessments of numerous early-stage protein biologics using a variety of predictive analytical and biophysical methods
• Carry out routine lab tasks including preparing buffers, managing the inventory of laboratory consumables and supplies when needed
• Support mAb and AOC drug substance/product process development activities when needed
• Be a hands-on presence in the laboratory and support biology and chemistry departments with analytical and biophysical characterization as needed
• Train lab personnel on the use of select instrumentation and methods
• Specify, purchase, and manage the installation of formulation-related instrumentation and equipment
• Maintain good documentation in an electronic notebook and write technical reports as required
• Present data at regular team and cross-functional team meetings

Qualifications

• A PhD in chemistry, biology, pharmaceutical sciences, or a related field (master’s or bachelor’s degree with 5 and 10 years industry experience, respectively, will be considered)
• 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
• Demonstrated excellent communication (oral and written), teamwork, organizational, interpersonal, and problem-solving skills
• Direct experience in any of the areas listed below would be viewed favorably but are not a requirement for the position:
• 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/MSP
• Experience in lyophilization formulation, cycle development, and analytical testing
• Experience in oligonucleotide chemistry and characterization methods
• Previous experience managing direct reports

Benefits

To be provided: Competitive compensation and benefits, including the opportunity for annual bonus as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off. A commitment to learning and development which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.