Reporting to the Chief Development Officer and closely interacting with our regulatory, clinical development, translational, and process development teams, the CMC Project Manager will perform a critical role in executing the pre-clinical and translational strategy for the Company. Key functions will include managing activities at multiple CMOs and analytical contract laboratories to ensure product development project goals and milestones are achieved. Phased activities will include product expressing cell line development through fill/finish of drug product. This role has a high level of complexity requiring wide technical and scientific expertise, involving all phases of CMC activities and interfaces.
Inhalon Biopharma is a rapidly growing startup with a patented breakthrough technology for preventing and treating acute respiratory infections such as respiratory syncytial virus (RSV), metapneumovirus (MPV) and SARS-CoV-2. The Company just completed a Seed round and has been awarded funding by the US Army to run a Phase 1/2a study in COVID-19 patients and has multiple NIH/SBIR grants to develop its pipeline of treatments for RSV, MPV, and influenza. Inhalon operates out of Durham, NC and the SF Bay Area.
The CMC Project Manager should have excellent communications skills and possess the ability to translate complex science to groups who may not possess a strong scientific background.
Interact and communicate with contract manufacturing and analytical laboratory organizations to coordinate cell line development, process development, assay development, cGMP manufacturing for DS and DP programs relating to CMC activities to support use in clinical testing.
Maintain detailed status updates to support multiple CMC product development projects.
Communicate project status updates and actions required for internal team members clearly and accurately.
Identify issues affecting project timelines and ensure management awareness to facilitate decision-making to mitigate such issues.
Maintain and ensure availability of CMC documentation necessary for regulatory filings or health authority interactions.
Monitor CMC related project costs to maintain and project budgets.
Assist Clinical Operations group as necessary to ensure continuity of material availability for use in supporting ongoing clinical trials.
Perform other duties as assigned.
This position will require domestic travel.
5+ years of experience in the pharmaceutical/biotech clinical research industry; with at least 3 years of relevant CMC Project Management work experience.
Ability to prioritize, organize and manage multiple projects simultaneously.
Working knowledge of GMP and GLP manufacturing and laboratory environments/requirements and familiarity with clinical trial packaging/labeling and distribution.
Strong cross-functional interpersonal skills.
Excellent oral and written communication and attention to detail.
Proficiency in MS Office suite, including Word, Excel, Project and PowerPoint.
Ability to travel up to 30% as needed.