Senior Director, AOC Process Development & Manufacturing - Oligonucleotide

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 SummaryThe Director/Senior Director of AOC Process Development and Manufacturing - 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.Job ResponsibilitiesLead Atrium's oligonucleotide process development and manufacturing activities at CMOsServe as CMC lead for one or more programsProvide subject matter expertise in oligonucleotide process development, scale‑up, and technology transferDevelop and execute late‑stage process characterization, validation, and manufacturing strategies in collaboration with CMOsManage tech transfer activities between CMOs and/or within CMOs for scale‑upPartner with QC, QA, and Analytical/Formulation teams to refine oligonucleotide specifications and control strategies for late‑stage clinical trials and commercializationCoordinate regulatory support with vendors and ensure alignment between Avidity RA and CMOsAuthor and review regulatory submissions, including INDs, amendments, and BLAsOversee oligonucleotide stability programs and shelf‑life extensions in collaboration with QCEnsure compliance with FDA, EMA, ICH, GCP, GMP, and Atrium policiesEducation and Experience RequirementsBachelor's degree in chemistry, chemical engineering, pharmaceutical science, or related field required; advanced degree (MS/PhD) preferredMinimum 10 years of pharmaceutical industry experience in large‑scale oligonucleotide synthesis and purificationProven experience in cross‑functional CMC teamsExpertise in oligonucleotide process development, manufacturing, scale‑up, and technology transferHands‑on experience with Phase 3/commercial readiness, process characterization, PPQ, and regulatory requirements for late‑stage manufacturingStrong background in GMP manufacturing and regulatory guidelines (US, EU, JP)Prior experience with IND and BLA/NDA filingsKnowledge of cGMP, ICH, FDA, and EMA guidelines for oligonucleotidesDemonstrated ability to collaborate effectively internally and externallyExcellent communication, leadership, and problem‑solving skillsAbility to manage multiple priorities in a fast‑paced environmentExcellent interpersonal skills, ability to work in a matrix environment and develop relationships with key stakeholdersExcellent communication and presentation skills to efficiently relay information to staff, project teams, executive leadership and other key stakeholdersProven ability to work independently and be self‑motivatedWhat we ProvideThe base salary range for this role is $266,000-$295,000. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factorsAtrium offers competitive compensation and benefits which include stock options, 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 unlimited of time off including spring, summer & winter breaksA commitment to learning and development which includes a variety of programming internally developed by and for Atrium employees, opportunities for job‑specific training offered by industry, and an education reimbursement programWe may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.#J-18808-Ljbffr