57 applicants
Avidity Biosciences, Inc. · 6 days ago
Associate Director, AOC (Oligo-linker) Process Development and Manufacturing
San Diego, California, United States
Full-time
Onsite
Director
$167K/yr - $194K/yr
8+ years exp
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Responsibilities
Assume technical responsibility for Avidity’s Oligonucleotide CMO process development and manufacturing for one or more programs.
Provide subject matter expert (SME) guidance for Oligonucleotide process development and scale-up.
Responsible for developing and executing late-stage manufacturing strategy to meet Avidity’s advancing pipeline.
Work with CMOs and QA to ensure timely release of Oligonucleotide intermediate.
Work with QC, QA, and Analytics & Formulations to refine Oligonucleotide specifications for late-stage clinical trials and commercialization.
Work with CMOs, QA, and Supply Chain to ensure timely delivery of Oligonucleotide to DS manufacturing sites.
Provide Person-In-Plant support for Oligonucleotide manufacturing runs.
Author relevant sections of Regulatory filings, including INDs, IND amendments, and BLAs.
Coordinate Oligonucleotide vendor regulatory support as needed and ensure communication between Avidity RA and Oligonucleotide CMOs.
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.
Manage Oligonucleotide tech transfer activities between CMOs and/or within CMOs for scale-up.
Work with the Analytics & Formulations team to design and manage Oligonucleotide development studies supporting commercial launch.
Provide technical support for Oligonucleotide OOS, OOT, deviations, change controls and nonconformance investigations.
Support Oligonucleotide process characterization, validation readiness, and PPQ campaign execution.
Identify and communicate risks to clinical programs and commercial supply chain due to 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.
Qualification
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Required
Minimum Bachelor’s degree in chemistry, chemical engineering, pharmaceutical science, or related field required. Master’s or PhD preferred.
Minimum of 8 years of pharmaceutical industry experience in Oligonucleotide synthesis and purification at large scale.
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 in GMP manufacturing and a strong understanding of US, EU, and JP regulations are required.
Prior IND and BLA filing experience.
Experience working with third-party CMOs.
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.
Benefits
401(k) with an employer match
Stock options and RSUs
Medical, dental, vision, and LTD coverage
Four weeks of time off
Company
Avidity Biosciences, Inc.
DELIVERING ON OUR VISION Our vision is to profoundly improve people’s lives by revolutionizing the delivery of RNA therapeutics.
51-200 employees
H1B Sponsorship
Avidity Biosciences, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (4)
Funding
Current Stage
Public CompanyTotal Funding
$747.07MKey Investors
RTW InvestmentsEli LillyTakeda
2024-02-29Post Ipo Equity· $400M
2022-12-15Post Ipo Equity· $207M
2020-06-11IPO· nasdaq:RNA
Leadership Team
Sarah Boyce
President & CEO
Andrew Geall
Vice President of Formulations and Chemistry
Recent News
Company data provided by crunchbase
