CMC Project Manager

Reporting to the Chief Development Officer, the CMC Project Manager will be part of a cross-functional team responsible for planning and managing the preclinical and clinical supply chain for Caraway’s small molecule development portfolio. The position will be responsible for planning, oversight of production and vendor management for chemical lead series, drug substance, drug product and finished materials, including labeling and packaging operations, logistics, and distribution for clinical supplies.  The position will work closely with colleagues and key external consultants across all functional disciplines.


Essential Duties and Responsibilities:

  • Oversees all aspects of drug substance, drug product, and finished goods supply planning, capacity planning, labeling/packaging development and operations, production scheduling and execution, logistics, and risk management for Caraway’s products
  • Oversees and actively manages relationships with all Contract Manufacturing Organizations to ensure production and inventory targets are communicated and met
  • Collaborates with research team to ensure appropriate supply for pre-clinical and IND-enabling animal studies
  • Works closely with Clinical Operations and Regulatory Affairs to actively manage label and secondary package design operations including development, proof review/approval, and communication to external partners
  • Leverages input from all critical functions to create integrated project plans that define goals, milestones, critical path, timeline, risks, assumptions, and alternative scenarios
  • Provides assistance to technical team as a subject matter expert for review of master and executed batch records / analytical data reviews
  • Provides input and data for regulatory filings
  • Responsible for the planning and management of supply forecasts, including preclinical study and clinical trial requirements and ongoing distribution strategies for clinical site supplies
  • Actively communicates, collaborates with, and contributes to other functional areas including Chemistry, Clinical Development, Regulatory Affairs, Quality Assurance, Finance, and external partners and drives to achieve the best business results for the company
  • Manages direct reports, as assigned
  • Performs other related duties as assigned or directed

Desired Skills & Experience:

Proven track record in pharmaceutical supply chain management including planning, CMO oversight, labeling and packaging, and logistics/distribution.  Broad experience in GMP operations and a proven track record of successfully leading and contributing to cross-functional teams are a key requirement.  International experience is a plus.  Excellent communication and collaboration skills across levels, functions, and organizations in a fast paced environment as well as a proven ability to execute and contribute strategically to achieve results in a virtual setting are a must. Other requirements are:

  • Bachelors or masters degree in a technical or scientific discipline
  • 5-7 years of relevant experience in the pharmaceutical industry
  • Up to 10% travel
  • Experience in labeling/packaging and logistics/distribution
  • Experience with solid oral dosage forms
  • Familiarity with preclinical drug development
  • Strong understanding of all aspects of biopharmaceutical drug development, including clinical, nonclinical, regulatory, CMC and quality
  • Capability to manage multiple projects and shifting priorities associated with an early stage drug development company
  • Prior exposure to orphan diseases is an asset
  • Tools and concepts of project management (e.g. management of resources, planning and budgeting, risk management, contingency planning, analysis and reporting, and written and verbal communication)
  • Proficient in the use of MS Word, Excel, PowerPoint and project management software