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
As Avidity advances programs into the clinic, an effective quality control strategy will be critical to ensuring reproducibility of our drug substance. We are seeking a Scientist or Senior Scientist to join the Analytics group who is experienced and committed to developing cell-based potency assays for later phase clinical programs. This individual will work across departments and must be able to communicate amongst them. 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
- Design the appropriate sequences for accurate and effective engineered cell lines for potency assays
- Be responsible for the timely implementation of cell-based potency assays for release of our siRNA or PMO antibody oligonucleotide therapeutics
- Lead the selection of a laboratory capable of method transfer and qualification of a GMP cell-based release assay
- Contribute to the selection and implementation of release specification for each potency assay
- Requires the ability to collaborate internally within Avidity's CMC, Analytics, and biology teams as well as externally across multiple CMOs and development laboratories
- Author or review relevant regulatory submissions
- Ensure reports are tracked through Avidity's QMS.
- Ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP and Avidity policies and procedures.
- Minimum PhD in biology, pharmaceutical sciences, bioengineering, or similar
- 3-10 years of pharmaceutical industry experience
- Deep knowledge of cell culture and molecular biology.
- 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.
Avidity is committed to complying with federal, state and local law on employee vaccinations. Job candidates should be aware that full vaccination against COVID-19 : is required subject to legally required exceptions. Avidity is an equal opportunity employer and encourages potential or current employees to request a reasonable accommodation under federal, state and local regulations, should one be needed.