Senior Director, AOC Analytical Development & Quality Control
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 Senior Director/Director of AOC Analytical Development & Quality Control will lead analytical strategy and quality control activities for oligonucleotide, monoclonal antibody (mAb), AOC drug substance and product across all development phases. This role is responsible for establishing robust analytical methods, ensuring compliance with regulatory requirements, and supporting CMC activities from early development through commercialization. The ideal candidate will have deep expertise in analytical method development and validation, stability programs, and experience managing teams and external partners.
Requirements
- Bachelorâs degree in chemistry, biochemistry, pharmaceutical sciences, or related field required; advanced degree (MS/PhD) preferred.
- Minimum 10 years of pharmaceutical industry experience in analytical development and QC for oligonucleotides and/or mAbs/AOC.
- Proven experience managing analytical development teams and external partners.
- Expertise in analytical techniques for oligonucleotides (e.g., LC, LC-MS, CE, UV) and mAbs/AOC (e.g., HPLC, CE-SDS, peptide mapping, glycan analysis, charge variants).
- Hands-on experience with method development, validation, and regulatory requirements for late-stage clinical and commercial manufacturing.
- Strong understanding of GMP, ICH, FDA, and EMA guidelines.
- Prior experience supporting IND and BLA/NDA filings and response to questions.
- Excellent leadership, communication, 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 analytical development and QC strategy for oligonucleotide, mAb, AOC DS and programs across early and late phases. Most work will be conducted at third party CROs and CMOs
- Develop, qualify, and validate analytical methods for oligonucleotide, mAb, AOC drug substances and drug products.
- Oversee QC activities, including release and stability testing, in compliance with cGMP requirements.
- Provide subject matter expertise on characterization, impurity profiling, and specification setting for oligonucleotides and mAbs/AOCs.
- Collaborate with CMOs and internal teams to ensure timely execution of analytical and QC deliverables.
- Support regulatory filings by authoring and reviewing analytical sections of INDs, amendments, and BLAs.
- Drive late-stage analytical activities, including method validation, comparability studies, and lifecycle management.
- Ensure robust stability programs and shelf-life extensions for oligonucleotide and mAb/AOC products.
- Partner with QA, Process Development, and Regulatory Affairs to maintain compliance and readiness for inspections.
- Identify and mitigate risks related to analytical and QC activities impacting clinical and commercial supply.
- Adhere to applicable regulations, including FDA, EMA, ICH, and Atrium policies.
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Director
