Associate Director - VP, Oligonucleotide CMC

Vivatides Therapeutics Inc.; Woburn (MA); On-site; USD 250,000 - 360,000; Full time

Job summary

Vivatides Therapeutics Inc. is seeking an Associate Director - Vice President, Oligonucleotide CMC to lead the full lifecycle management of oligonucleotide therapeutics, from process development and pilot production to IND filing and NDA/BLA commercialization, with regulatory submissions ownership.

The role requires a Ph.D. in a relevant field and 5+ years of oligonucleotide CMC experience, strong project management, cross-functional leadership, and the ability to build robust quality systems

Qualifications

• Ph.D. required in a relevant field with emphasis on oligonucleotides.
• 5+ years of oligonucleotide CMC experience across development to NDA/BLA.
• Strong problem-solving and analytical skills for CMC bottlenecks.
• Proven capability to manage budgets, timelines and risks.
• Experience with external CDMO relationships and negotiations.
• Knowledge of GMP, ICH and global regulatory expectations.
• Fluent English, excellent scientific writing and communication.

Responsibilities

• Formulate and execute CMC strategy for oligonucleotide programs.
• Lead process development, pilot scale, and IND/NDA submission activities.
• Oversee quality control and regulatory documentation.
• Drive cross-functional collaboration across R&D, QA, and Regulatory.
• Manage CDMOs and vendor relationships to control quality and costs.
• Ensure timely delivery of milestones and robust risk management.
• Mentor and lead a growing CMC team.

Skills

CMC for oligonucleotides

Project management

Cross-functional collaboration

Regulatory submissions

Team leadership

Quality systems

Communication (English)

Education

Ph.D. in Organic/Medicinal Chemistry, Biochemistry, Pharmacy

Tools

DoE

QbD

FMEA

Job description

Job Location: Suzhou or Shanghai or Tianjin, China; or Boston, US

Position Summary:

We are an exciting start-up with amazing opportunities to develop next generation RNA therapeutics. We are seeking an experienced Associate Director - Vice President, Oligonucleotide CMC to oversee the full lifecycle management of oligonucleotide therapeutics, spanning from process development, pilot production, and IND filing to commercialization (NDA/BLA). Successful candidates will also be core team members for drug quality assurance and global regulatory submissions.

Primary Responsibilities:

• 1. Strategic Planning & Execution: Formulate the company's CMC process development strategy and ensure its efficient implementation. Conduct scientific feasibility assessments on nucleic acid projects based on medicinal chemistry expertise. Manage the entire lifecycle of oligonucleotide drugs from process development, pilot production, and IND filing to commercialization (NDA/BLA).
• 2. Process Optimization & Troubleshooting: Lead process optimization for drug substances (API), drug products, and analytical methods using advanced quality tools such as DoE, QbD, and FMEA. Solve critical bottlenecks during technology transfer to ensure data accuracy and reproducibility, while proactively identifying and mitigating project risks.
• 3. Efficient Project Management: Independently drive CMC project management, establish key milestones, efficiently integrate internal and external premium resources, and strictly control timelines to ensure high-quality and on-time project delivery.
• 4. Quality System Development: Participate in establishing, improving, and implementing the process of development of quality management system, while maintaining relevant Standard Operating Procedures (SOPs) and quality control standards.
• 5. Vendor (CDMO) Management: Responsible for the screening, commercial negotiation, and technical management of external contract organizations to finely control project quality, schedule, and costs.
• 6. Regulatory Submission & Compliance: Lead the authoring, reviewing, and submission of drug registration dossiers. Ensure technical documents comply with domestic and international regulatory requirements (such as NMPA, FDA, EMA) as well as GMP and ICH guidelines.
• 7. Cross-functional Collaboration: Partner with R&D, Pre-clinical, Clinical Medical, Regulatory Affairs, and other departments to ensure the smooth progression of technology transfer, IND filings, and NDA/BLA activities.

Qualifications:

• 1. Educational Background: Ph.D. degree in Organic Chemistry, Medicinal Chemistry, Biochemistry, Pharmacy, or related fields.
• 2. Core Experience: 5+ years of experience in oligonucleotide drug CMC. Candidates who have navigated the entire pipeline, including process development, pilot production, IND filing, and NDA/BLA commercialization are highly preferred.
• 3. Technical Expertise: Proficient in the core principles of medicinal chemistry, with outstanding troubleshooting and analytical problem-solving skills for CMC process bottlenecks in innovative drug development.
• 4. Project Management Skills: Extensive project management experience adept at cost control and time management with excellent capabilities in risk anticipation and crisis management.
• 5. Business & Communication: Strong cross-departmental and cross-functional team collaboration skills alongside mature experience in managing external CDMO supply chains.
• 6. Team Leadership: 3+ years of experience in managing process development teams with excellent skills in team building, talent cultivation, and motivation.
• 7. Regulatory Knowledge: Proficient in domestic and international drug registration processes, as well as mainstream international regulatory requirements such as GMP and ICH.
• 8. Core Attributes: Strong sense of responsibility, highly self-motivated with strong execution skills, excellent stress tolerance, and a collaborative team spirit.
• 9. Language Proficiency: Fluent in English (listening, speaking, reading, and writing), capable of independently and proficiently writing international-standard regulatory submission dossiers in English.