RTP North Carolina or remote
Satsuma Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing STS101 (dihydroergotamine mesylate (DHE) nasal powder) as an important and differentiated therapeutic option for the acute treatment of migraine.
Satsuma’s lead product, STS101, is a novel and proprietary investigational drug-device combination product specifically designed to enable intranasal administration of the anti-migraine drug DHE, with a pharmacokinetic profile designed to provide reliable, robust, and consistent clinical performance in the acute treatment of migraine. In developing STS101, Satsuma has applied proprietary nasal drug delivery device, dry-powder formulation, and engineered drug particle technologies to create a compact, simple-to-use, non-injectable DHE product that can be quickly and easily self-administered in matter of seconds.
The Director of Analytical will report to the Head of CMC and will be a key leader in the CMC team. The role will work with external contract research organizations analytical testing labs (including contract manufacturing organizations) to lead the development, transfer (as needed), and qualification of the analytical testing methods associated with the drug-device combination product(s) being developed by Satsuma. In addition, the role will include the ability to analyze data and make conclusions and recommendations based on those analyses. An important part of the role is to ensure the CMC approaches to the NDA (as well as other regulatory submissions) are sound and high quality work is performed.
Duties and Responsibilities:
- Develop robust analytical test methods that meet quality and regulatory requirements.
- Manage the transfer of analytical methods between sites, as well as ensure successful qualification, validation, and maintenance of them.
- Analyze data to determine trends, reach conclusions, and propose actions for the product and/or the methods themselves.
- Report writing and oversight of internal and external reports.
- Devise approaches to and contents of the analytical aspects of Satsuma’s regulatory submissions (IND, NDA, MAA).
- Manage data for reporting in regulatory submissions, including drafting analytical sections of the submissions.
- Manage all logistics related to analytical testing of R&D, non-clinical and clinical supplies.
- Supervise junior staff.
- Collaborate with all functions of the business to ensure consistent delivery of the programs.
Minimum Requirements Education/Experience:
- Bachelor’s degree in analytical chemistry or similar.
- Minimum of 10 years’ experience in pharmaceutical industry in an analytical method development and/or analytical testing role.
- Minimum of 3-5 years’ experience working with across different cultures and disciplines.
- Experience in drug-device combination products preferred.
- Strong analytical problem-solving skills a must.
- Excellent communication skills, with an ability to work in cross-functional teams including across multiple sites.
- Must be self-motivated have ability to work on own initiative.
- Strong quality orientation with attention to detail.
- Ability to identify problems and to be innovative and effective in developing solutions, mitigating execution risk.
- Collaborative leader with ability to strongly influence with or without authority, facilitate groups with diverse perspectives, and bring teams to consensus/alignment.
- High tolerance for ambiguity and change – able to create order from chaos.
- Takes accountability for actions, drives results, learns from mistakes; is direct and truthful and therefore widely trusted – delivers on promises, goals, and expectations.
- Makes quality decisions and resolves problems rapidly.
- Ability to communicate effectively at all levels of the organization.
- Excellent planning and prioritization, with an ability to multitask and adapt – able to synthesize large amount of information and deliver results despite shifting environment.
For additional information:
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