Top 3 Must Have Skill Sets:
Synthetic (Small Molecule) Drug Substance and Drug Product Method Development
Synthetic (Small Molecule) Drug Substance and Drug Product Stability Study Knowledge
Synthetic (Small Molecule) Drug Substance and Drug Product Method Qualification
Day to Day Responsibilities:
Day to day oversite of analytical analytical programs at external vendors including:
- Set up new drug substance and drug product programs (method development, feasibility and qualification) at external vendors
- Movement of materials/samples between sites
- Ownership of PO’s, invoices and budget accounting
- Overseeing investigations and deviations that occur
- Set up new and oversee existing stability studies at the site
- Overseeing standard and sample inventory at the site
- Maintain metrics (method tracking, project tracking)
The External Process Development organization is seeking a highly qualified candidate to support analytical assay outsourcing associated with execution of external development and clinical supply. The position will be a key enabling role in a high performing cross functional organization. The associate will be responsible for supporting analytical demand for assay execution related to stability and development.
Analytical background in drug substance/product testing. Experience in small molecule (synthetics). knowledge of stability testing for those products. Familiar with ICH guidelines and GMP/GLP testing.
Must hold a minimum of a B.S. in Biology/Chemistry or related field.
This person will be interacting with outsourced partners and must have excellent communication skills. Ability to multitask.
"This posting is for Contingent Worker, not an FTE"