Director of Analytical Chemistry
Job ID: 1808CMC
Email resumes to: moc.o1537435799iprea1537435799@sree1537435799rac1537435799
Aerpio Pharmaceuticals, Inc, a Cincinnati-based pharmaceutical company, is actively recruiting a highly experienced, knowledgeable and collaborative Director of Analytical Chemistry to lead clinical-phase analytical development activities. This newly-created position will report to the Head of CMC.
The Company is developing multiple clinical-stage compounds, and the Director will oversee and drive all drug substance and drug product analytical activities which will be performed by external suppliers. It is critical for the candidate to have experience developing and validating analytical methods across all clinical stages through the use of external resources, and to have significant experience managing projects performed at contract development-manufacturing organizations (CDMO). The candidate must also have significant experience preparing regulatory submissions and working with Quality Assurance to investigate OOS/OOT results. Ideally, the candidate will also have experience developing and validating bioanalytical methods for non-clinical studies, as well as experience working with monoclonal antibody products.
Specific responsibilities include:
- Manage all method development, method validation, and testing activities at CMC suppliers
- Work with CMC team to develop specifications for all regulated materials (drug substance, drug product, intermediates, standards, impurities, metabolites, etc.)
- Lead all impurity/standard/metabolite identification and sourcing activities
- Lead all analytical troubleshooting and OOS/OOT investigations
- Prepare analytical sections of all CMC regulatory submissions
- Oversee the development and implementation of method validation and stability programs
- Provide analytical support to internal functions (pharmacokinetics, toxicology, antibody development, etc.) as needed
- PhD with 10 years of experience in clinical-stage pharmaceutical development; MS/BS candidates with exceptional experience will be considered
- Demonstrated ability to manage multiple development projects at multiple suppliers; significant experience working with external suppliers highly preferred
- Demonstrated ability to develop and validate phase-appropriate methods for early- and late-stage materials
- Demonstrated ability to work in a fast-paced, agile environment in a self-directed manner
- Demonstrated ability to develop regulatory strategies for products at all clinical stages; well-versed in ICH/USP/FDA/EMA requirements for method validation and stability programs
- Experience in preparing analytical sections of CMC regulatory submissions
- Experience in development of specifications for drug substances, drug products, etc.
- Experience with a wide variety of analytical instruments and wet chemistry techniques highly desired, including UPLC/HPLC, KF, FTIR, NMR, LC-MS, ICP, GC-MS, and XRPD
- Experience developing and validating bioanalytical methods for non-clinical studies, as well as experience working with monoclonal antibody products desired, but not required
"Start by doing what is necessary, then what is possible, and suddenly you are doing the impossible."
- Francis of Assisi
We plan to revolutionize the treatment of diabetic eye disease, by treating earlier stage disease and providing a treatment option to patients that currently have none. An audacious goal, no doubt, but at Aerpio we believe the right people, with the right attitude, united for a common purpose can achieve anything.
Send us your CV if you think you're one of these people.