Job Description

The Head, Pharmaceutical Development & Commercial Manufacturing is responsible for all aspects of Chemistry Manufacturing and Controls for Corbus’ lead small molecule candidates from lead phase to marketed product. This position is responsible for overseeing the entire drug development including RSM’s, intermediates, API and drug product manufacturing, formulation development, analytical methods development culminating in approvable CMC sections and efficient and effective commercial manufacturing processes.

PRIMARY RESPONSIBILITIES:

• Plan all aspects of lead candidate CMC development from IND to NDA/MAA submission. Plans will cover all aspects of stage appropriate development of GPM manufacturing for clinical trials and commercial supply.

• Manage, direct and inspire staff responsible for drug substance and drug product development, manufacturing, and analytical method development activities for small molecules

• Provide strategic and technical oversight of all aspects of the finished product drug supply chain from lead candidate to commercial product

• Prepare RFPs and negotiate contracts with vendors for manufacturing of Regulatory Starting materials (RSM) API, drug product, etc. and formulation development, etc.

• Prepare and manage budgets

• Oversee production and quality control testing of clinical trial supplies

• Select and manage outside vendors

• Prepare, review and approve CMC and IMPD sections of regulatory filings

• Ensure compliance with requirements for CMC regulatory submissions

• Prepare for and attend meetings with regulatory authorities involving CMC questions

• Review and edit CMC final reports, manufacturing process documentation, investigator brochures, clinical study protocols, and clinical trial documentation for compliance with cGMPs, cGLPs and other appropriate regulations and guidelines for CMC related issues

• Act as liaison (with regulatory and quality personnel) with FDA, and other regulatory agencies for all CMC related topics

• Review proposed changes to regulated processes and /or products to identify regulatory implications

• Work closely with regulatory and quality systems organizations to identify and resolve any CMC issues

• Work closely with clinical and Sr. management to provide strategic and operational planning for all aspects of supply chain from early development to commercialization.

•Interact with key scientific, clinical research, marketing and commercial personnel within and outside the Company to ensure timely and accurate regulatory compliance on CMC matters.

Qualifications

SKILLS & REQUIREMENTS:

• 15+ years of experience in industry as a CMC professional managing from early development to commercialization of DS and DP manufacturing and clinical supply chain

• Experience in all phases of regulatory submissions and interactions with US and international regulatory authorities on CMC related topics

• Senior management leadership experience for the CMC function in a pharmaceutical or biotech company

• Knowledge and experience with DEA regulations, business plans and negotiating

• Strong aptitude to think strategically with excellent analytical, communication, presentation, and writing skills

• Proven ability to work as a team member collaboratively with colleagues across all functions

• PhD degree in pharmaceutical sciences or chemistry required

Additional Information

All your information will be kept confidential according to EEO guidelines.