Associate Director/Director, Product Development – Pulmonary Focus (Remote)
Seattle, WA · Biotech/Pharmaceutical
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