Senior Director, Technical Product (San Diego)

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 and engage with us on LinkedIn and Twitter .

The Opportunity

The Senior Director , Technical Product Lead (TPL) is a senior leader within the Technical Development Dep artment responsible for representing the CMC matrix on multiple program teams in our expanding pipeline and sitting on Program Teams as the Tech Ops representative. This TPL will also be responsible for establishing the Technical Development Strategy team , which will manage t he Tech Ops Leadership for all programs in the pipeline and standardiz e TPL ways of working. The ideal candidate will bring a s trong knowledge of CMC Leadership with deep technical understanding of Oligonucleotide and/or Bioconjugation process development, tech transfer, manufacturing, CMC regulatory strategy and Agency interactions. Th e Senior Director Technical Product Lead will be responsible for the cross-functional review of IND /IMPDs BL A , represent CMC in interactions with Regulatory Agenc ies and interfacing with Third Party development and manufacturing.

What You Will Contribute

• Head and build out the Tech nical Development Strategy Function
• Cross-functional Tech Ops Lead member of Program Core Team for 1 or 2 late-phase and 1 or 2 early-phase programs
• Responsible for Tech Ops Strategy for program and represents Tech Ops at the Program level
• Cross-functional review of all Tech Ops docs including:
  • IND/IMPD, RTQs and other regulatory documents
  • Representative in Reg ulatory Interactions
  • Scale up and tech transfer protocols
  • Pharmacy Manual
  • Comparability package
  • Specifications
  • PC/PV documentation
• Close interactions with clinical supply and clinical/commercial manufacturing planning
• Presenting Program Stage G ate at the Steering Committee s
• Present Tech Ops strategy in Program governance
• Author and review relevant sections of Regulatory filings , including INDs, IND amendments, and BLAs.

• Identify and communicate risks to clinical programs and commercial supply chain due to process and manufacturing delays.
• P articipate in developing appropriate risk mitigation strategies for Tech Ops activities.

• Adhere to applicable regulations, including FDA, EMA, ICH, GCP, GMP, and Avidity policies and procedures.

What We Seek

• Minimum Bachelor’s d egree in chemistry , chemical engineering , pharmaceutical science, or related field required. Master ’ s or PhD preferred.

• Minimum of 12 years of pharmaceutica l industry experience in bioprocess, or oligonucleotide PD and Manufacturing .
• Minimum of 6 year s of pharmaceutica l industry experience i n a CMC leadership role for a biologics , or oligonucleotide mid to late-phase program.
• 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 C D MOs.
• Prior IND and BLA /NDA filing experience .

• Knowledge of cGMP, ICH, FDA, and EMA guidelines .
• 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 W ill Provide to You:

• The base salary range for this role is $ 261,250- $ 288 ,000 . 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.