[Hiring] Principal Scientist, Biologics Process Development @Avidity Biosciences Inc

Role Description

We are seeking a highly motivated and experienced downstream process development leader to support late-stage biologics programs through licensure and lifecycle management. This role will serve as the technical lead for downstream process development activities across clinical and commercial programs and will be accountable for process design, optimization, characterization, validation readiness, and regulatory authorship.

This is a primarily hands-on role (approximately 70% technical execution / 30% strategic leadership) supporting monoclonal antibodies, antibody-related variants, and antibody-oligonucleotide conjugates. The successful candidate will operate as a key CMC contributor for BLA-stage programs and will play a central role in regulatory filings and health authority interactions.

This position is structured as a flexible-level hire at either the Principal Scientist or Associate Director level, depending on experience.

What You Will Contribute

• Technical Leadership & Execution
  • Serve as the technical lead for downstream process development from late clinical stage through commercialization.
  • Design, optimize, and characterize purification processes including Protein A capture, polishing chromatography, viral clearance, filtration, and UF/DF.
  • Lead process characterization studies to identify and justify critical process parameters (CPPs), support control strategy development, and enable process performance qualification (PPQ).
  • Drive process robustness, scalability, and lifecycle management strategies consistent with commercial manufacturing requirements.
  • Troubleshoot purification performance issues across development, scale-up, and commercial manufacturing.
  • Provide technical oversight for scale-up and technology transfer activities to manufacturing sites.
  • Review and approve development protocols, reports, and technical documentation.
  • Interpret process development data to support regulatory filings and internal decision-making.
• Regulatory & CMC
  • Author and own downstream process development sections of regulatory submissions (e.g., IND, BLA Module 3), including process description, control strategy, and process characterization summaries.
  • Support responses to regulatory questions and participate in health authority interactions as subject matter expert.
  • Ensure process development documentation supports comparability, validation, and commercial readiness.
  • Contribute to control strategy development and regulatory justification of CPPs and IPCs.
• Cross-Functional Collaboration
  • Partner closely with Upstream Development, Analytical Development, Manufacturing, Quality, Regulatory, and Supply Chain.
  • Contribute to integrated CMC strategy and program risk assessments.
  • Support internal and external manufacturing campaigns through data review and real-time problem solving.
  • Provide mentorship and technical guidance to junior scientists.
• Strategic Contribution (30%)
  • Contribute to downstream platform evolution and technical innovation.
  • Support long-term process optimization and lifecycle management planning.
  • Help build internal technical capabilities aligned with commercial strategy.
  • May assume people leadership responsibilities as the organization grows.

Qualifications

• Ph.D. in Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with 5+ years of relevant experience OR
• M.S. with 8+ years of experience OR
• B.S. with 12+ years of experience
• Level will be commensurate with experience and demonstrated leadership.

Requirements

• Extensive experience in downstream process development for monoclonal antibodies or related biologics, including chromatography-based purification and filtration operations.
• Experience with viral clearance strategies and regulatory expectations for viral safety.
• Demonstrated experience supporting late-stage clinical programs and commercial readiness.
• Direct authorship of CMC sections for IND and BLA submissions.
• Experience defining CPPs and leading process characterization studies.
• Strong understanding of scale-up, tech transfer, and process validation.
• Experience supporting regulatory inspections or health authority interactions.
• Proven troubleshooting skills in purification processes.

Preferred Experience

• Experience with antibody variants or antibody-oligonucleotide conjugates.
• Experience supporting CDMO manufacturing and technology transfer.
• Experience supporting commercial manufacturing.
• Experience in comparability assessments and post-approval change management.
• Prior experience in a matrixed biotech environment.
• Demonstrated ability to lead without formal authority.

Core Competencies

• Deep technical expertise in downstream biologics processing.
• Strong regulatory writing and CMC strategy skills.
• Ability to operate independently in a fast-paced late-stage environment.
• Excellent cross-functional communication skills.
• Strategic thinking with hands-on execution capability.
• Strong problem-solving and data-driven decision-making skills.
• Ability to build alignment, foster collaboration, and drive shared ownership across functions to achieve results in a complex, matrixed environment.
• Ability to travel to Avidity’s San Diego headquarters approximately twice per year for company development weeks and occasional in-person collaboration.
• Demonstrated openness to adopting digital and AI-enabled tools that enhance data analysis, process understanding, and decision-making.

Benefits

• The base salary range for this role is $171,000 to $189,000. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity, and market factors.
• Avidity offers competitive compensation and benefits, which includes the opportunity for annual bonus 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 four weeks of time off.

Additional Details

• Title: Principal Scientist, Biologics Process Development
• Location: Remote
• Position Type: Full Time / Exempt
• Department: Process Development - MAB
• ID: 7625-Q224-7
• #LI-Remote