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 - 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 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 Oligonucleotides (AOC) Technical Development and support clinical/commercial manufacture of Avidity’s current and future AOC programs. The person should have prior hands-on manufacturing experience and excellent knowledge of oligonucleotide manufacturing process including supporting Change Controls, Deviations, Investigations, Process Scale-up and Tech Transfers.

What You Will Contribute

• Assume responsibility for oligonucleotide manufacturing processes, review master and executed batch records, and provide subject matter expert (SME) guidance for deviations, investigations, change controls, GMP tech transfers and manufacturing campaigns.
• Perform detailed technical review of batch documents to support the timely release of cGMP batches.
• Be responsible to Tech Transfer documentation and ensure successful transfer of processes to CMOs.
• Provide person-in-plant support during manufacturing runs and/or campaigns.
• Work with CMOs, QA and Supply Chain to ensure timely delivery of oligonucleotide to drug substance (DS) sites in time for DS bioconjugation.
• Support the drug substance (DS) team, which is responsible for the manufacture of the AOCs, on an as-needed basis.
• Provide CMC support for regulatory filings including INDs, CTAs, amendments and NDA/BLA as needed.
• Ensure adherence to applicable regulations including FDA, EMA, PMDA, ICH, GCP, GMP and Avidity policies and procedures.
• Provide PMI and COGM assessments for processes and unit operation scenarios.

• Work with QC, QA and Analytics & Formulations to refine oligonucleotide specifications for late-stage clinical trials and commercialization.

• Provide technical support for oligonucleotide OOS, OOT, deviations, change controls and, nonconformance investigations.
• Support oligonucleotide process characterization, validation readiness and PPQ campaign execution.

What We Seek

• Bachelor’s or Master’s degree in Chemistry, Biochemistry, Chemical Engineering or related field required.
• A minimum of 7 years of relevant industry experience in manufacture of oligonucleotide. The person should have:
  • Experience with large-scale oligonucleotide manufacturing including synthesis, downstream purification, annealing, and additional processing
  • Experience supporting deviations, investigations, change controls, batch record reviews and process tech transfers
  • On-the-floor GMP manufacturing experience

• Prior experience in clinical pivotal/commercial readiness process development and manufacturing, process characterization, control strategy, and PPQ with knowledge of QA and Regulatory requirements for late-stage manufacturing.
• Prior IND and BLA filing experience.
• Be familiar with tools used to evaluate PMI and COGM values.
• Experience working with third-party CMOs.

• Proven track record of effective 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, team-oriented, collaborative and be able see the big picture.

What We will Provide to You:

• The base salary range for this role is $142.5K-$157.5K. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.
• Avidity offers competitive compensation and benefits which includes 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.