Associate Scientist I, Formulation Development

About the role

We are seeking a highly motivated individual eager to work in a fast-paced and collaborative environment as an Associate Scientist I within the Analytical and Formulation group of Avidity’s Technical Development and Operations (TD&O) department. This position will focus primarily on the clinical and commercial formulation development of AOC drug product and drug substance. Additional responsibilities may include supporting the developability assessments of early-stage mAb and AOC assets and performing in-use compatibility studies for intravenous and subcutaneous routes of administration.

The successful candidate will have experience in analytical and biophysical characterization, formulation development, and stability testing of protein biologics, preferably for mAbs and antibody-drug conjugates (ADCs). Strong interpersonal, organizational, and communication skills are essential as this role requires close collaboration with cross-functional team members as well as periodic communication with external research organizations and vendors. This position reports to the Principal Scientist within the Analytics and Formulation group and is laboratory-based at the Avidity site in San Diego, CA. Non-laboratory functions such as data processing and documentation may be completed remotely.

Responsibilities

• Work with TD&O team members to set up and conduct formulation stability studies of mAb and AOC liquid and lyophilized dosage forms
• Perform developability assessments of numerous early-stage protein biologics using a variety of predictive analytical and biophysical methods
• Perform routine lab tasks including preparing buffers, managing the inventory of laboratory consumables and supplies, and working with vendors for maintenance and troubleshooting of analytical instruments
• Conduct in-use compatibility studies of AOC drug products intended for intravenous and subcutaneous routes of administration
• 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
• 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
• Contribute to the company’s core values (agile, visionary, integrated, and diverse)

Requirements

• A bachelor’s degree (or master’s) in chemistry, biology, pharmaceutical sciences, or a related field with a minimum of 5 years of industrial experience (3 years for a master’s degree)
• An understanding of protein physicochemical stability, particularly for common routes of mAb degradation
• Experience in setting up and managing formulation development and in-use compatibility studies
• 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 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

Preferred Qualifications

• Experience using design of experiment (DOE) approaches
• 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

Benefits

• Competitive compensation with a base salary range of $99,750-$110,250
• Annual bonus opportunity
• 401(k) with employer match
• Comprehensive wellness program including medical, dental, vision, and long-term disability coverage
• Four weeks of time off
• Commitment to learning and development, including internally developed programming, job-specific training, and an education reimbursement program

Location: Hybrid - San Diego, CA & Remote. Position Type: Full Time / Exempt.