Senior Director, Technical Product
Location: San Diego
Posted on: June 23, 2025
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Job Description:
Job Title: Senior Director, Technical Product Location: San
Diego, CA / Hybrid / Remote Position type: FLSA: Full time Exempt
Department: Finance ID: TD&O 7625-Q224-3 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, Technical Product
Lead (TPL) is a senior leader within the Technical Development
Department 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 the Tech Ops Leadership for all programs in
the pipeline and standardize TPL ways of working. The ideal
candidate will bring a strong knowledge of CMC Leadership with deep
technical understanding of Oligonucleotide and/or Bioconjugation
process development, tech transfer, manufacturing, CMC regulatory
strategy and Agency interactions. The Senior Director Technical
Product Lead will be responsible for the cross-functional review of
IND/IMPDs BLA, represent CMC in interactions with Regulatory
Agencies and interfacing with Third Party development and
manufacturing. What You Will Contribute Head and build out the
Technical 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 Regulatory 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 Gate at the Steering Committees 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.
Participate 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 degree in chemistry,
chemical engineering, pharmaceutical science, or related field
required. Master’s or PhD preferred. Minimum of 12 years of
pharmaceutical industry experience in bioprocess, or
oligonucleotide PD and Manufacturing. Minimum of 6 years of
pharmaceutical industry experience in 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 CDMOs. 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 Will 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. Avidity Biosciences 10578 Science Center Dr.
Suite 125 San Diego, CA 92121 O: 858-401-7900 F: 858-401-7901
Keywords: , Bellflower , Senior Director, Technical Product, Science, Research & Development , San Diego, California
