Director, CMC-Drug Substance

Director, CMC-Drug Substance

We are seeking a Director, CMC-Drug Substance to join our growing organization. Reporting to the VP, CMC & Program Management, and focused upon drug substance CMC activities, the Director's primary responsibility will be to collaborate with our external contract manufacturing partners to develop, manufacture, analyze, release, and deliver the clinical supplies required to support our ongoing development programs. This is a critical position within the organization which requires ensuring and enabling alignment with corporate strategic goals, regulatory guidance documents regarding pharmaceutical development, timelines, and budget constraints.

This is an on-site role to ensure seamless and timely communication and interaction with project teams.

Essential Responsibilities:

• Develop and execute integrated CMC strategies for drug substance across all phases of development through commercialization
• Lead DS-related activities for regulatory filings (IND, CTA, BLA/MAA), ensuring alignment with global regulatory expectations
• Serve as the Drug Substance CMC subject matter expert on cross-functional program teams with particular emphasis upon antibody-oligonucleotide conjugates
• Oversee drug substance manufacturing activities for AOC and siRNA drug substances
• Manage relationships with CDMOs and ensure timelines, budgets, and deliverables are met
• Drive process scale-up, process characterization, and validation strategies
• Ensure manufacturing readiness for clinical and commercial supply
• Provide deep expertise in biologics manufacturing platforms (e.g., CHO cell systems, fermentation, purification)
• Support analytical development and comparability assessments for process changes
• Troubleshoot manufacturing challenges and implement risk mitigation strategies
• Author and review CMC sections of regulatory submissions
• Ensure compliance with GMP and global regulatory standards
• Partner with Quality to ensure audit readiness and successful inspections
• Collaborate closely with Clinical, Regulatory, Quality, Supply Chain, and Finance teams
• Contribute to program governance, timelines, and risk assessments
• Mentor and develop internal team members (as applicable)
• Other duties as defined.

Essential Physical Characteristics:

Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis.

On-Site Protocol:

Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

Qualifications:

• Masters Degree and/or PhD in Chemical Engineering, Biochemistry, Biotechnology, or related field is strongly preferred
• 12+ years or BS with 15+ years of experience in biotech/pharmaceutical industry
• Significant experience in CMC development for biologics drug substances, antibody-drug conjugates (ADCs), AOCs, or siRNAs
• Demonstrated success overseeing manufacturing at CDMOs
• Experience supporting IND through late-stage development (BLA experience strongly preferred)
• Strong understanding of upstream/downstream biologics manufacturing processes

Preferred Experience:

• Experience with monoclonal antibodies, recombinant proteins, or RNA-based therapeutics
• Prior experience in a small to mid-size biotech environment
• Regulatory interaction experience (e.g., FDA, EMA meetings)

Required Key Attributes:

• Must be able to work independently with supervision as needed.
• Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism.
• Self-motivated with exceptional interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment.
• Excellent written and verbal communication skills for effective presentation of complex scientific data to cross-functional and senior management teams are essential for this role.
• Exceptional understanding of project timelines and deliverables…