CMC Coordinator, GMP Manufacturing & Regulatory Support
Opus Genetics
Summary
Opus Genetics is seeking a CMC Coordinator with experience supporting GMP manufacturing activities, regulatory documentation, and material logistics in a biotechnology or pharmaceutical environment.
Job description
About the Role
Opus Genetics is seeking a CMC Coordinator with experience supporting GMP manufacturing activities, regulatory documentation, and material logistics in a biotechnology or pharmaceutical environment.
Working within Chemistry, Manufacturing, and Controls (CMC), you'll maintain controlled documentation, coordinate shipments, and support audit and inspection readiness for our gene therapy programs. You'll collaborate with Quality, Regulatory, Development, contract manufacturing partners, and external laboratories.
This role requires experience in a GMP manufacturing environment. General administrative experience alone will not meet the needs of the position. Clinical experience related to investigational drug supply is a plus.
What You'll Do
- Organize and maintain CMC documentation, including batch records, technical reports, protocols, specifications, and regulatory support documents.
- Support controlled-document routing, approvals, filing, version control, and archiving.
- Coordinate shipments of materials and samples to contract development and manufacturing organizations (CDMOs), contract laboratories, clinics, and other partners.
- Maintain shipping records, chain-of-custody documentation, and shipment tracking logs.
- Support regulatory documentation requests and audit or inspection readiness by organizing, tracking, and retrieving CMC and quality records.
- Track CMC deliverables, document requests, and action items.
- Coordinate CMC meetings and follow-up activities as needed.
- Work across internal teams and external partners to ensure documentation and logistics activities meet GMP requirements and company procedures.
Required Experience and Skills
- At least two years of relevant experience in biotechnology, pharmaceuticals, or related regulated operations.
- Experience working in or directly supporting a GMP manufacturing environment, including document control, quality systems, or CMC operations.
- Regulatory experience supporting documentation, compliance activities, or regulatory submissions in a biotechnology or pharmaceutical setting.
- Experience coordinating supply chain logistics and working with external partners.
- Experience in a small- to midsized biopharma environment.
- Experience supporting quality audits, inspection readiness, or QA documentation review.
- Experience maintaining controlled documents and accurate, traceable records.
- Proficiency in Microsoft Office and electronic document management systems.
- Strong organizational, written communication, and follow-through skills.
- Ability to manage multiple priorities independently and collaboratively.
Preferred Qualifications
- Clinical experience related to investigational drug supply, such as coordinating study-material shipments or maintaining drug-supply records.
- Bachelor's degree in Biology, Chemistry, Biotechnology, Pharmaceutical Sciences, Quality Assurance, or a related scientific discipline.
- Ophthalmology experience.
- Experience in a startup environment.
Location and Compensation
This position is onsite in Durham, North Carolina. Candidates must be able to work onsite; local candidates are strongly preferred.
Annual salary: $85,000 to $115,000
Requirements
- At least two years of relevant experience in biotechnology, pharmaceuticals, or related regulated operations
- Experience working in or directly supporting a GMP manufacturing environment, including document control, quality systems, or CMC operations
- Regulatory experience supporting documentation, compliance activities, or regulatory submissions in a biotechnology or pharmaceutical setting
- Experience coordinating supply chain logistics and working with external partners
- Experience in a small- to midsized biopharma environment
- Experience supporting quality audits, inspection readiness, or QA documentation review
- Experience maintaining controlled documents and accurate, traceable records
- Proficiency in Microsoft Office and electronic document management systems
- Strong organizational, written communication, and follow-through skills
- Ability to manage multiple priorities independently and collaboratively
- Clinical experience related to investigational drug supply (preferred)
- Bachelor's degree in Biology, Chemistry, Biotechnology, Pharmaceutical Sciences, Quality Assurance, or a related scientific discipline (preferred)
- Ophthalmology experience (preferred)
- Experience in a startup environment (preferred)
Company overview
Opus Genetics is a clinical-stage ophthalmic biotechnology company focused on developing innovative gene therapies to treat inherited retinal diseases (IRDs) and restore vision in patients with severe retinal disorders. Headquartered in Durham, North Carolina, the company specializes in creating durable, one-time treatments designed to address the underlying genetic causes of vision loss. Their pipeline includes seven adeno-associated virus (AAV)-based gene therapy programs targeting various genetic mutations associated with retinal degeneration, including OPGx-LCA5 for Leber congenital amaurosis 5, OPGx-BEST1 for bestrophinopathies, and programs targeting RHO, CNGB1, RDH12, NMNAT1, and MERTK mutations. The company also has an FDA-approved small-molecule therapy, Phentolamine Ophthalmic Solution 0.75%, for pharmacologically induced mydriasis, with additional potential indications in development. Opus Genetics employs a strategy centered on regulatory rigor, capital efficiency, and disciplined clinical development, led by a management team with deep expertise in ophthalmology, gene therapy, and drug development. Their mission is to translate scientific breakthroughs into transformative therapies that can make a lasting difference for patients with inherited retinal diseases and other vision conditions affecting millions worldwide.