CMC Director

Proclinical is currently is seeking a CMC Director for a pharmaceutical company located in New York, NY. The Director of CMC is accountable for Manufacturing and Development efforts in leading the development of clinical through commercialization processes for API and Drug Product Manufacturing, Packaging, Labelling and Logistics. This position reports to the SVP of Regulatory, CMC & QA.

Job Responsibilities:

• Assertive "hands-on" CMC, work with Contract Manufacturing Organizations (CMOs) to develop production plans and provide technical support while ensuring timelines for clinical and commercialization efforts are met.
• Work with CMOs in developing Manufacturing Processes and Analytical Methods.
• Provide recommendations, reviews and approvals of protocols, processes, batch records, stability studies and final reports.
• Oversee and approve technical transfer of Ovid methods and processes.
• Support GMP efforts to ensure alignment with Regulatory requirements.
• Develop and negotiate Supply Agreements with CMOs for Ovid products.
• Oversee process validation where applicable.
• Develop or revise SOPs applicable to CMC by working with QA and Regulatory to ensure company policies are adhered to.
• Oversee CMOs comply with Ovid company policies and regulatory requirements.
• Prepare CMC regulatory filing sections (domestic and international) working with Regulatory and Quality.
• Establish CMC reports and provide updates to Senior Management.

Skills and Requirements:

• Minimum BS in Chemistry or related Science. MA/MS or PhD preferred.
• 10+ years hands-on CMC and management experience with focus on manufacturing/quality/clinical from development through commercialization in the Pharmaceutical industry.
• Experience with oral solid and liquid dosage forms.
• Direct experience effectively managing API and Drug Product CMOs.
• Significant knowledge of GMP and FDA regulations related to CMC.
• Proficient in authoring and preparing CMC documentation for regulatory submissions.
• Strong knowledge of Clinical trials supplies management.
• Excellent interpersonal communication skills and be highly collaborative when interacting within and outside the organization.
• Demonstrated personal leadership and ability to effectively direct multiple projects with positive results within project timelines.
• May require both international and domestic travel, up to 15 percent.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Nicholas Walker at (+1) 646-367-2908 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

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

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