Avidity Biosciences, Inc. San Diego , CA 92140
Posted 2 months ago
Job Title:
Associate Scientist I, Formulation Development
Location:
Hybrid
Position type:
FLSA:
Full time
Exempt
Department:
Analytics and Formulations, CMC
Strive to Bring a Profound Difference to our Patients
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
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
What We Will Provide to You:
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
Avidity Biosciences, Inc.