Senior Director, AOC Process Development & Manufacturing - Oligonucleotide

Atrium Therapeutics•San Diego, CA

23d•$266,000 - $295,000

About The Position

Atrium is a biopharmaceutical company pioneering delivery of RNA therapeutics to the heart to transform the standard of care for people living with cardiomyopathies. Our proprietary technology leverages the targeted RNA delivery platform initially designed at Avidity, which combines the tissue selectivity of mAbs and other targeted delivery ligands with the precision of oligonucleotides. This unique combination is designed to allow selective targeting of the underlying genetic drivers of disease that were previously undruggable. Through targeted, non-viral delivery of siRNA to cardiac tissues, our approach has the potential to overcome key limitations of nonspecific viral and nanoparticle-based delivery systems, including challenges related to tissue specificity, immunogenicity, and redosing. Job Summary: The Director/Senior Director of AOC Process Development and Manufacturing â Oligonucleotide will lead all aspects of oligonucleotide process development and manufacturing, including establishing technology transfer for Phase 1/2 programs and scale-up to Phase 3 and commercial production. This role requires deep expertise in oligonucleotide synthesis, modifications, purification techniques, and analytical methods, as well as a strong understanding of cGMP and CMC strategy. Prior experience serving as a CMC lead at the program level is highly desirable. The position also includes responsibility for authoring and reviewing Module 3 sections of INDs and BLAs related to oligonucleotide manufacturing.

Requirements

Bachelorâs degree in chemistry, chemical engineering, pharmaceutical science, or related field required; advanced degree (MS/PhD) preferred.
Minimum 10 years of pharmaceutical industry experience in large-scale oligonucleotide synthesis and purification.
Proven experience in cross-functional CMC teams
Expertise in oligonucleotide process development, manufacturing, scale-up, and technology transfer.
Hands-on experience with Phase 3/commercial readiness, process characterization, PPQ, and regulatory requirements for late-stage manufacturing.
Strong background in GMP manufacturing and regulatory guidelines (US, EU, JP).
Prior experience with IND and BLA/NDA filings.
Knowledge of cGMP, ICH, FDA, and EMA guidelines for oligonucleotides.
Demonstrated ability to collaborate effectively internally and externally.
Excellent communication, leadership, and problem-solving skills.
Ability to manage multiple priorities in a fast-paced environment
Excellent interpersonal skills, ability to work in a matrix environment and develop relationships with key stakeholders.
Excellent communication and presentation skills to efficiently relay information to staff, project teams, executive leadership and other key stakeholders
Proven ability to work independently and be self-motivated

Responsibilities

Lead Atriumâs oligonucleotide process development and manufacturing activities at CMOs.
Serve as CMC lead for one or more programs
Provide subject matter expertise in oligonucleotide process development, scale-up, and technology transfer.
Develop and execute late-stage process characterization, validation, and manufacturing strategies in collaboration with CMOs.
Manage tech transfer activities between CMOs and/or within CMOs for scale-up.
Partner with QC, QA, and Analytical/Formulation teams to refine oligonucleotide specifications and control strategies for late-stage clinical trials and commercialization.
Coordinate regulatory support with vendors and ensure alignment between Avidity RA and CMOs.
Author and review regulatory submissions, including INDs, amendments, and BLAs.
Oversee oligonucleotide stability programs and shelf-life extensions in collaboration with QC.
Ensure compliance with FDA, EMA, ICH, GCP, GMP, and Atrium policies.