Associate Scientist I, Formulation Development at Avidity Biosciences

Job Title:

Associate Scientist I, Formulation Development

Location:

Hybrid - San Diego, CA and Remote

Position type:

FLSA:

Full time

Exempt

Department:

Analytics and Formulations, CMC

At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people’s lives by delivering a new class of RNA therapeutics. Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. If you are a committed, solution-oriented thinker, join us in making a difference and become part of our growing culture that is integrated, collaborative, agile and focused on the needs of patients. 

Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs™). Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare muscle diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Avidity is broadening the reach of AOCs with its advancing and expanding pipeline, including programs in cardiology and immunology through internal discovery efforts and key partnerships. Avidity is headquartered in San Diego, CA. For more information about our AOC platform, clinical development pipeline, and people, please visit www.aviditybiosciences.com and engage with us on LinkedIn and Twitter.

The Opportunity

We are seeking a highly motivated individual eager to work in a fast-paced and collaborative environment as an Associate Scientist within the Analytical and Formulation group of Avidity’s Chemistry, Manufacturing and Controls (CMC) department. This position will focus primarily on the clinical and commercial formulation development of AOC drug product and drug substance.  Additional responsibilities may include but are not limited to 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 a strong scientific background and demonstrated experience in analytical and biophysical characterization, formulation development, and stability testing of protein biologics, preferably for mAbs and antibody-drug conjugates (ADCs).  Strong interpersonal and communication skills are essential as this position will require close collaboration with cross-functional team members as well as periodic communication with external research organizations and vendors.  This position will report to the Principal Scientist within the Analytics and Formulation group, which is laboratory-based at the Avidity site in San Diego, CA.  Non-laboratory functions such as data processing and documentation, however, may be completed remotely.

What You Will Contribute

• Work with CMC team members to set up and conduct formulation stability studies of mAb and AOC liquid, frozen 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
• 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
• Contributes to the company’s core values (agile, visionary, integrated and diverse)

What We Seek

• A Bachelor’s degree (or Master’s) in chemistry, biology, pharmaceutical sciences, or a related field with a minimum of 6 years of industrial experience (4 years for a Master’s degree).
• An in-depth understanding of protein physicochemical stability, particularly for common routes of mAb degradation
• Direct experience in optimizing solvent conditions to maintain 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
• Direct experience in any of the areas listed below would be viewed favorably but are not a requirement for the position:
  • Familiarity with mass spectroscopy (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

• The base salary range for this role is $94,000 - $104,000. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.
• Avidity offers competitive compensation and benefits, including the opportunity for annual and spot bonuses, stock options, and RSUs, 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.

Avidity Biosciences

10578 Science Center Dr. Suite 125

San Diego, CA

92121

O: 858-401-7900

F: 858-401-7901