Associate Director/Director, Product Development – Pulmonary Focus (Remote)
NWRPros
- Seattle, WA
- Permanent
- Full-time
- Together with SVP Product Development:
- develop and implement comprehensive plans to meet CMC needs that include drug substance, drug product and analytics
- plan and execute drug product manufacturing activities for the company to ensure regulatory compliance, quality and timelines are met
- plan, develop and employ project-specific CMC resource and budget plan to ensure agreed goals and spending targets are met
- participate in formulation research and product development of company pipeline product opportunities
- Work with senior management and other project team members to select and qualify CMOs/CROs
- Communicate effectively and transparently with functional heads within pharmaceutical development and other company stakeholders (Quality, Toxicology/DMPK, Clinical/Regulatory, Operations, Project, etc.)
- Provide oversight during manufacture of drug products at CMOs
- Liaise with analytical contract laboratories to oversee shipping and release clinical trial supplies and to monitor drug product stability as required for clinical studies and product registration
- Work with packaging/labeling CMO to maintain adequate clinical supply inventory to support ongoing clinical studies
- Provide technical expertise to contribute to new project selection for the company
- Contribute significantly to lead selection/optimization, formulation development/process and clinical development of pipeline asset(s) selected for program advancement
- Provide support to CMC writing for regulatory submissions, board update, due diligence, etc.
- A PhD or advanced degree in Pharmaceutics, Chemical Engineering or equivalent with 10+ years of industrial experience
- Direct experience in formulation development and manufacturing of sterile solution-based drug products (experience in inhalation devices is a plus)
- Direct experience in managing clinical labeling and packaging of clinical supplies with CMOs
- Experience in managing CMC/analytical activities at different stages of drug development programs
- Have authored relevant pre-IND, IND and NDA CMC/analytical sections
- Preference will be given to candidates with direct CMC/analytical experience in approved inhalation drug products