Director, CMC-Drug Substance

Job Description:

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 and plans/coordinate project work accordingly with departmental, functional, and external stakeholders.

Compensation:

• This is a full-time position, Monday-Friday, occasional overtime.
• Pay is commensurate with experience.
• Equity-based compensation
• Performance-based bonuses
• 401(k) with Company Match
• Medical, Dental, Vision
• Flexible Spending Account
• Life Insurance
• Employee Assistance Program
• Employee Discounts 
• Gym Membership
• Paid Vacation
• Paid Holidays
• Paid Sick, Jury Duty, Bereavement

Work Authorization:

• United States (Required)
• Background Check
• As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check.

Company Overview:

ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system.

ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

Disclosure Statement:

• The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
• Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
• The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law.
• Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses.
• Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.