Description

Job Title:

Senior Director, AOC (Oligo-linker) Process Development and Manufacturing

Location:

San Diego, CA / Hybrid / Remote

Position type:

FLSA:

Full time

Exempt

Department:

Finance ID:

Technical Development

7625-Q224-6

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

The Senior Director of AOC Process Development and Manufacturing – Oligo-linker is a senior leader managing a team accountable for all aspects of Oligonucleotide Process Development and Manufacturing, including initial tech transfer of Phase 1/2 and scale-up to Phase 3/Commercial Manufacturing. The ideal candidate will bring a strong knowledge of oligonucleotide synthesis and oligo-modifications, purification techniques, and analytical methods, as well as a working knowledge of cGMP and CMC strategy/leadership.  Experience as a CMC lead at the program level will be an advantage for this role.  The Senior Director AOC Process Development and Manufacturing will be responsible for authoring and reviewing module 3 IND sections as well as BLA sections related to Oligonucleotide manufacture.

What You Will Contribute

Lead the Oligonucleotide CMO process development and manufacturing team. Assume technical responsibility for Avidity’s Oligonucleotide CMO process development and manufacturing for one or more programs.Assume CMC Leadership on a program team for one or more programs (early and late phase)Provide subject matter expert (SME) guidance for Oligonucleotide process development and scale-up at our CMOs.Responsible for developing and executing late-stage process characterization, validation and manufacturing strategies in collaboration with our CMOs to deliver Avidity’s advancing pipeline.Manage Oligonucleotide tech transfer activities between CMOs and/or within CMOs for scale-up.Work with QC, QA, and Analytics & Formulations to refine Oligonucleotide specifications for late-stage clinical trials and commercialization.Coordinate Oligonucleotide vendor regulatory support as needed and ensure communication between Avidity RA and Oligonucleotide CMOs.Author and review relevant sections of Regulatory filings, including INDs, IND amendments, and BLAs.Work with the QC stability team to ensure that Oligonucleotide shelf-life extensions are executed in a timely manner.  Provide SME oversight of Oligonucleotide stability programs.  Support Oligonucleotide process characterization, validation readiness, and PPQ campaign execution.Identify and communicate risks to clinical programs and commercial supply chain due to process and manufacturing delays.Participate in developing appropriate risk mitigation strategies for Oligonucleotide supply.Adhere to applicable regulations, including FDA, EMA, ICH, GCP, GMP, and Avidity policies and procedures.

What We Seek

Minimum Bachelor’s degree in chemistry, chemical engineering, pharmaceutical science, or related field required. Master’s or PhD preferred.Minimum of 15 years of pharmaceutical industry experience in Oligonucleotide synthesis and purification at large scale.Experience managing a team of process development SMEs.Expertise in Oligonucleotide process development, manufacture, scale-up, and technology transfer.Prior experience in clinical Phase 3/commercial readiness process development and manufacturing, Process Characterization, and PPQ with knowledge of QA and Regulatory requirements for late-stage clinical and commercial manufacturing.Experience working with third-party CMOs.Experience in GMP manufacturing and a strong understanding of US, EU, and JP regulations are required.Prior IND and BLA/NDA filing experience.Knowledge of cGMP, ICH, FDA, and EMA guidelines regarding Oligonucleotides.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. What We Will Provide to You:The base salary range for this role is $256,500 - $283,500. The final compensation will be commensurate with 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