RTP North Carolina
Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic for the acute treatment of migraine. Our lead drug candidate, STS101, is a drug-device combination of a proprietary dry-powder formulation of dihydroergotamine mesylate, or DHE, capable of being quickly and easily self-administered by a proprietary pre-filled, single-use, nasal delivery device. STS101 is currently being evaluated in a Phase 3 clinical trial.
Reporting to the Analytical Lead, the Analytical Manager will work with external analytical testing labs (including those at contract manufacturing organizations) to oversee routine and non-routine analytical testing associated with the drug-device combination product(s) being developed by Satsuma. In addition, the Analytical Manager will compile data, perform trend analyses, and make conclusions and recommendations based on analyses.
Duties and responsibilities:
- Responsible for day-to-day management of analytical activities at established CROs.
- Responsible for managing all logistics related to analytical testing of R&D, non-clinical and clinical supplies.
- Proactively identify and address issues that arise during routine analytical testing.
- Responsible for compiling and performing trend analyses of data as well as presenting data and results to support product development decisions.
- Create and review documentation, including investigations, change controls, analytical test methods, and study protocols.
Behaviors / skills:
- Ability to effectively collaborate across all functions of the business so as to ensure consistent and timely achievement of program deliverables.
- Excellent communication skills, with an ability to work in cross-functional teams including across multiple sites.
- Excellent planning and prioritization, with the ability to multitask and adapt.
- Takes accountability for actions, drives results, learns from mistakes; is direct and truthful and therefore widely trusted; deliver on promises, goals and expectations.
- Self-motivated, with the ability to plan own work.
- Strong quality orientation with keen attention to detail.
- Makes quality decisions and resolves problems rapidly.
- Demonstrated ability to influence across different cultures.
Education & experience
- Bachelor’s degree in analytical chemistry or similar discipline.
- Minimum of 7 years’ experience in pharmaceutical industry in an analytical method development and/or analytical testing role.
- Minimum of 2 years working with or managing contract testing laboratories desired.
- Direct experience conducting or managing ICH stability programs required.
- Experience compiling stability data using LIMS and authoring analytical sections for regulatory submissions desired.
For additional information:
Please send your resume or CV to us at firstname.lastname@example.org