Scientist/Sr. Scientist, Formulations

At Avidity Biosciences, we are passionate about the impact of every employee in bringing potentially life-changing therapeutics to patients in need. Avidity is pioneering a new class of oligonucleotide-based therapies called AOCs designed to overcome the current limitations of oligonucleotide therapies to treat a wide range of serious diseases. We utilize our proprietary AOC platform to design, engineer and develop transformative therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) and the precision of oligonucleotide-based therapies to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases. If you are a committed, solution-oriented thinker, come make a difference with us.

Job Summary 

Avidity has advanced our first program into the clinic and is continuing to be innovative in making improvements to our AOCs as well as improving patient experience. We are seeking a Scientist or Senior Scientist to join the Formulations and Analytics group who has experience in the development of high concentration formulations for biologics to help achieve these goals. This position will report to the Senior Director, Formulations and Analytics and be a part of Avidity’s growing CMC/Technical Operations team.

Essential Duties and Responsibilities  

• Conduct biophysical characterization and formulation studies to support evaluation of AOC candidate formulations. Techniques include, SEC, CEX/AEX, DSC, HIC, CE-SDS, icIEF, SoloVPE, MFI, HIAC, and NTA.
• Proven experience in utilizing QbD approaches to develop robust and reliable products
• Optimize formulation components to enable stability of antibody oligonucleotide therapeutics at high concentration
• Ensure excipients are compatible with patient dosing
• Performs compatibility and in-use stability studies to support the drug dose administration.
• Experience with regulatory considerations for devices (prefilled syringes, autoinjector syringe) a plus.
• Lead the tech transfer of a developed formulation to CMO for high concentration product development.
• Requires the ability to collaborate internally within Avidity’s CMC, Analytics, and formulation teams as well as externally across multiple CMOs and development laboratories
• Authors and reviews formulation development sections of regulatory and technical documents and study reports.
• Ensure reports are tracked through Avidity’s QMS.
• Ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP and Avidity policies and procedures.

Qualifications

• Minimum PhD in pharmaceutical sciences, bioengineering, or similar
• 3-10 years of pharmaceutical industry experience
• Deep knowledge of formulations for monoclonal antibody, ADC, or other biologics
• Ideal candidate will have knowledge of GXP, ICH, FDA, EMA guidelines and requirements across development, registration, and validation.
• Proven track record of effective collaboration with external quality control and contract manufacturing organizations.
• Proven ability to thrive and enable success in a cross-functional and collaborative environment.
• Excellent communication and interpersonal skills and the ability to facilitate constructive, expedient problem-solving.
• Ability to multi-task, manage conflict, and work in a fast-paced environment.