Senior/Principal Scientist/Associate Director, Biologics Purification Process Development and Manufa

Company Overview 

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 Antibody Oligonucleotide Conjugates (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

We are seeking an experienced and highly energetic person who is interested in helping Avidity grow into a late-stage clinical and commercial manufacturing company. The person will report to the Senior Director of Biologics Manufacturing and support activities that include process development, process characterization/validation and clinical/commercial manufacture of Avidity’s mAbs. The person should have prior hands-on experience and excellent knowledge of downstream (purification) process unit operations used for manufacture of mAbs expressed by CHO cells. In the future, the person will be responsible for establishing internal process development capabilities to complement the development and manufacture of mAbs by CDMOs.

Essential Duties and Responsibilities

• Assume responsibility for mAb purification processes and provide subject matter expert (SME) guidance for process development, process characterization/validation, and manufacturing.
• Perform detailed technical review of batch documents to support the timely release of cGMP mAb batches.
• Organize development and manufacturing process data for trending and monitoring purposes.
• Provide person-in-plant support during mAb manufacturing runs.
• Work with CMC team to design and manage development studies supporting clinical advancement and commercialization.
• Review experiment designs, protocols, and technical reports for process characterization
• Work with CMOs, QA and Supply Chain to ensure timely delivery of mAb to drug substance (DS) sites in time for DS manufacturing.
• Support the drug substance (DS) team, which is responsible for the manufacture of the AOCs, on an as needed basis.
• Work with QC, QA and Analytics to refine mAb specifications as programs advance through clinical development.
• Provide CMC support for regulatory filings including INDs, CTAs, amendments and NDA/BLA as needed.
• Ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP and Avidity policies and procedures.

Qualifications

• Minimum Bachelor’s degree in chemical engineering, biochemical engineering, bioengineering, biochemistry, or related field required. Advanced degree (MS or PhD) preferred.
• A minimum of 5 years of relevant industry experience in the development of purification processes to manufacture biologics, including mAbs. The person should have:
  • Strong fundamental knowledge and understanding of mAb purification unit operations.
  • Excellent understanding of in-process analytics required for mAb processes.
  • Prior experience with viral clearance.
  • Experience with process characterization and validation.
  • Experience with design-of-experiment (DOE) and statistical analysis of experimental data.
• Experience working with third-party CMOs is desired.
• Experience in GMP manufacturing, along with strong understanding of regulatory guidelines, is desired.
• Proven track record of effective internal and external collaboration.
• 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.
• Must be detail oriented and the same time be able see the big picture.