Director, CMC Analytical Development

Director of CMC Analytical Development - Permanent - Redwood City, CA

Proclinical is seeking a visionary and experienced Director for CMC Analytical Development.

Primary Responsibilities:

The successful candidate will play a crucial role in overseeing analytical activities related to drug substance and drug product, ensuring top-notch quality and regulatory compliance. This role is instrumental in advancing our pipeline of therapies for rare diseases.

Skills & Requirements:

• Master's degree or Ph.D. in chemical engineering, chemistry or another related scientific field.
• Experience in CMC analytical development, with small molecule experience.
• Deep knowledge of outsourced DS clinical development through commercialization.
• Substantial experience in managing US CRO/CMOs for the analytical activities associated with the manufacture of cGMP DSs and DPs.
• Knowledge of GMP quality systems.
• Strong project leadership presence with excellent organizational skills and strong attention to details.
• Strong technical judgment; a problem solver with the ability to successfully and proactively identify and manage potential risks across all relevant areas.
• Strong knowledge of regulatory requirements and guidelines for drug development and analysis.
• Excellent leadership, communication, and interpersonal skills.
• Ability to work effectively in a fast-paced, dynamic environment.
• Ability to travel as required by the business.

The Director of CMC Analytical Development's responsibilities will be:

• Create and put into place CMC analytical strategies to assist with drug development and regulatory submissions.
• Collaborate with VP, CMC to align analytical activities with company goals and regulatory requirements.
• Guide the development, completion and implementation of analytical methods for drug substances and products.
• Ensure the integrity, accuracy, and compliance of analytical data.
• Prepare and review CMC analytical sections of regulatory submissions, including IND, BLA, NDA, and MAA.
• Prepare for and develop data-driven responses to regulatory requests for information related to analytical activities.
• Represent the company in regulatory interactions and inspections related to analytical activities.
• Manage analytical project timelines, budgets, and resources to ensure on-time delivery of milestones.
• Coordinate with cross-functional teams, including R&D, quality, regulatory, and clinical, to support CMC analytical activities.
• Stay current with advancements in analytical technologies and methodologies.
• Implement new technologies and best practices to enhance analytical capabilities and efficiencies.

Compensation:

• $200,000 to $245,000 annually

If you are having difficulty in applying or if you have any questions, please contact Eloise Coly at (+1) 617-830-1627 or e.coly@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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