Director, Small Molecule Development

ClinicalPro is seeking a Director, Small Molecule Development for a leading organisation specialising in Small Molecule research located in the USA.

This individual will be responsible for assuring reliable, expandable, and efficient procedures for the production of clinical and commercial small molecule products.

Must be eligible to work in the USA.

Responsibilities

• Specialises in the definition of chemical processes, control plans, and CMC Quality by Design (concepts for the production of small molecule API and medicinal products.
• Responsible for offering technological solutions to execute stage-appropriate process optimisation and enhancement for chemical development.
• Conducts risk analyses of clinical and commercial processes and applies QbD concepts to the formulation and updating of control strategies.
• Offers professional direction and assistance for root cause analyses and factory troubleshooting.
• Works with cross-functional matrix teams to collaborate with external manufacturing, CMC regulatory, quality assurance, and analytical development.
• Exercises leadership to identify solutions to issues, set priorities, and select the best courses of action for implementation.
• Provides assistance with the creation of CMC material submissions and correspondences.
• Contributes technically to process monitoring.
• Ensure product history and processes.
• Handles in-process reviews and regulatory filings.
• Promotes an inclusive workplace, supports a quality culture, stimulates innovation, and motivates performance with a feeling of urgency to satisfy patients’ demands.
• Expands the Technical Operations organization’s internal technical and scientific skills.

Skills and Requirements

• 10 years of industry experience in the creation of pharmaceutical medication compounds and/or products with a BS or MS in chemistry or a closely related degree.
• Ph.D. in chemistry or a related field with seven years of professional experience developing pharmaceutical medication substances or other products.
• Show capacity for team leadership with expertise in talent development.
• Excellent scientific communication abilities.
• Strong interpersonal and teamwork abilities.
• Have the capacity to collaborate across departments.
• Strength in meeting strict timelines to enable the development of drug substances and products and commercial filing.

Apply

If you’re interested in this position, apply now to send us an updated copy of your CV, or give us a call right away.

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