11 дней назад
Senior Director, Analytical Sciences
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Director, Analytical Sciences (Pharmaceutical CMC): Developing and executing analytical strategies for drug substances, raw materials, drug products, and medical devices with an accent on method development, validation, transfer, stability programs, and regulatory submissions. Focus on directing external laboratories and consultants, analyzing release and stability data, and resolving quality and compliance issues across clinical and commercial programs.
Location: Remote position
Company
develops innovative therapies for dermatological diseases, including skin cancers, with a commercial treatment and additional products in development.
What you will do
- Develop and execute the CMC department's analytical strategy for clinical development and commercial supply.
- Set specifications and oversee analytical testing for drug substances, raw materials, drug products, peptides, small molecules, and devices.
- Direct analytical method development, validation, transfer, lifecycle management, and stability programs.
- Manage contract laboratories, CROs, CDMOs, consultants, suppliers, and other external technical resources.
- Review analytical data, perform trending, and prepare technical documentation and regulatory submission sections.
- Provide subject matter expertise on quality investigations, regulatory interactions, SOPs, and cross-functional product development decisions.
Requirements
- PhD in Analytical Chemistry or a related field.
- At least 15 years of progressively responsible experience in Analytical Sciences within the pharmaceutical and/or medical device industries.
- Extensive experience with drug product analysis, raw materials, specifications, method development, validation, and transfer.
- Knowledge of applicable regulations, regulatory processes, and requirements.
- Experience managing teams with diverse analytical backgrounds and analytical work performed by CROs or CDMOs.
- Strong written and oral communication skills.
Culture & Benefits
- Fast-paced environment with direct access to senior leaders.
- Autonomy, trust, and the opportunity to shape access strategy and commercial operations.
- Competitive compensation, equity, and performance-based discretionary bonus.
- Medical, dental, and vision insurance, plus a 401(k) plan and paid time off.
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