Scientist I, Formulation Development

About the role

Avidity Biosciences is revolutionizing the field of RNA with its proprietary AOCs, designed to deliver a new class of RNA therapeutics. This position 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
• Work with vendors for maintenance and troubleshooting of analytical instruments
• 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
• Strong interpersonal, organizational, and communication skills are essential as this position will require close collaboration with cross-functional team members
• 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

Skills

• Strong scientific background and demonstrated experience in analytical and biophysical characterization
• Experience in formulation development and stability testing of protein biologics, particularly for mAbs and antibody-drug conjugates (ADCs)

Benefits

• Competitive compensation and benefits package including annual bonus and a 401(k) with an employer match
• Comprehensive wellness program covering medical, dental, vision, and LTD
• Opportunities for job-specific training offered by industry and an education reimbursement program
• Commitment to learning and development through various internally developed programming and training opportunities

Pay

The base salary range for this role is $127,300-$140,700. The final compensation will be commensurate with relevant experience, skillset, internal equity, and market factors.

Schedule

This position is hybrid - San Diego, CA and Remote.