Senior Director, AOC Process Development & Manufacturing - Oligonucleotide

Atrium Therapeutics; San Diego (CA); On-site; USD 266,000 - 295,000; Full time

Benefits offered by this job

Stock options

401(k) with employer match

Comprehensive wellness program

Unlimited time off

Job summary

A biopharmaceutical company in San Diego is seeking a Director/Senior Director of AOC Process Development and Manufacturing to oversee oligonucleotide synthesis and manufacturing. The ideal candidate will have over 10 years of experience in the pharmaceutical industry and a deep understanding of regulatory standards. Responsibilities include leading tech transfer for various programs, managing CMC activities, and ensuring compliance with FDA and EMA regulations. The role offers a competitive salary and benefits, including stock options and unlimited time off.

Qualifications

• Minimum 10 years of pharmaceutical industry experience in oligonucleotide synthesis.
• Expertise in regulatory requirements for late-stage manufacturing.
• Proven CMC leadership experience.

Responsibilities

• Lead oligonucleotide process development and manufacturing activities.
• Provide subject matter expertise in oligonucleotide processes.
• Author and review regulatory submissions related to manufacturing.

Skills

Oligonucleotide process development

Leadership

Regulatory knowledge (cGMP, FDA)

Analytical methods

Communication skills

Education

Bachelor's degree in chemistry or related field

Advanced degree (MS/PhD)

Job description

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 - 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 Responsibilities

• Lead Atrium’s 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

Education and Experience Requirements

• Bachelor’s 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

What we Provide

• The 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 factors
• Atrium 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 breaks
• A 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 program

We 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.