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Job: VP of Drug Development, Full Scale Solutions, Inc., Raleigh, NC

General Information

Job title:
VP of Drug Development
Job location:
Raleigh, NC  99999 United States
Requisition code:
Date posted:
Commensurate upon experience.
Job category:
Product Development
Employment type:
Full time

Job Description

Overall responsibility for drug substance and drug product activities transitioning from preclinical development through clinical supplies for Phase 3 registration studies and eventual transition to commercial supply

Essential Functions
Provide guidance and direction for project strategy, goals, budgets and other operational activities.
Is the senior technical leader for the CMC Team, integrating internal and external team members’ activities into the pharmaceutical development plan and presents plans and progress to the Senior Leadership Team.

Identification, selection and management of Contract Manufacturing Organizations (CMOs) for process optimization, cGMP manufacture and supply of Drug Substance (DS) and Drug Product (DP) for both small and large molecule development programs

Develop and implement a strategy for optimizing and controlling quality and with using CROs and CMOs

Delivery of robust, scalable and cost-effective manufacturing routes and drug product formulations appropriate for use in clinical trials

Develop material needs for all pre-clinical and clinical activities and manage the resulting budgets and timelines

Collaborate with the clinical team to establish and ensure a solid supply chain for clinical trial materials

Direct efforts to implement stage appropriate analytical methods and protocols to ensure CROs/CMOs are using systems and processes in compliance with all relevant regulatory standards

Through CROs and CDMOs, execute plans for the validation and registration of DS and DP as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations

Accountable for all CMC associated regulatory and quality documents associated with INDs, NDAs, and other regulatory submissions and documentation; represent the company as the Pharmaceutical Development expert before U.S. and European regulatory authorities

Assists in the development of and ensures compliance of Company, site, and safety policies and procedures.

Job Requirements

Ph.D. with 10+ years of experience in a pharmaceutical or biotechnology CMC/cGMP environment; Advanced degree in Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, Chemical Engineering or related discipline

Extensive experience in managing the US and International CRO/CMOs for the manufacture of cGMP DS and DP

Substantial experience with projects in late pre-clinical and clinical development (Phase 1 through Phase 3)

Experienced with cGMP manufacturing and IND, CTA and NDA filings; thorough knowledge of relevant FDA and EMEA regulations

Proven track record of superior interpersonal and communication skills with the ability to develop a strong positive relationship with senior management as well as all levels of the organization.

Embrace the following values in all decision making across the organization:
Collaboration, Patient Focus, Innovation, Uncompromising Integrity, and Excellence.    
Ability to operate effectively within an entrepreneurial and science-driven company environment; self-motivated, delivery-oriented, assertive, able to inspire others, driven and hands-on with unquestionable integrity and the highest ethical standards
(Job number: 3833688)
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