Civica - Petersburg, VA
posted 19 days ago
Full-time - Senior
Petersburg, VA
51-100 employees
Professional, Scientific, and Technical Services
About the position
The Associate Director of Product Development for Biologics/Biosimilars at Civica Rx will oversee the pharmaceutical product development for biosimilar products, particularly focusing on insulin analogs. This role involves leading drug development from early phases through to commercialization, establishing development plans, and providing technical direction for successful product outcomes. The position requires collaboration across internal disciplines and external partners, ensuring regulatory compliance and effective communication of development strategies.
Responsibilities
- Lead the design and execution of biologics drug product formulation and process development.
- Oversee scale-up and technology transfer activities of bioproducts to manufacturing sites.
- Translate product development project requirements into a robust technical design.
- Resolve complex problems using engineering principles, including Quality by Design (QbD) and Design of Experiments (DoE).
- Communicate development plans, risks, and mitigation strategies to stakeholders and management.
- Understand manufacturing principles for parenteral drug products and device assembly.
- Deliver Technology Transfer Plans throughout the product lifecycle.
- Participate in product Failure Modes Effect Analysis (FMEA) and root cause analysis for troubleshooting.
- Support regulatory preapproval inspections and audits from outside agencies.
- Review and approve cGMP documents and technical reports.
- Establish an R&D laboratory near the Civica manufacturing site and mentor team members.
Requirements
- Doctoral degree in pharmaceutics, pharmaceutical sciences, chemical engineering, or related disciplines.
- 12+ years of relevant industrial experience.
- Proven ability to solve critical scientific problems.
- Experience with biologics formulation and process development.
- Experience with sterile injectables and specialty biosimilars preferred.
- Strong knowledge of regulatory expectations for pharmaceutical product development.
- Experience with Design of Experiments (DoE) and data visualization tools.
Nice-to-haves
- Experience with predictive stability for bioproducts.
- Experience in genetic medicine formulation and process development.
Benefits
- Competitive salary
- Health insurance
- Retirement savings plan
- Paid time off
- Professional development opportunities
