Associate Director/Director, Product Development – Pulmonary Focus (Remote)

NWRPros

  • Seattle, WA
  • Permanent
  • Full-time
  • 1 month ago
Our Client is seeking a highly motivated individual at the Associate Director/Director level to join its Product Development team. This individual will play a key role in advancing the Company’s lead AP01 program and expanding the Company product pipeline to treat rare lung diseases. This is a remote position and will be reporting to the Senior Vice President, Product Development.Key Responsibilities:
  • 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.
The ideal candidate for this role will have:
  • 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

NWRPros