Executive Director, Commercial Manufacturing & Technical Operations – Raleigh Pharma/Top $$

Our client, a rapidly-expanding pharmaceutical firm headquartered in the Raleigh area, is actively recruiting for a highly skilled, knowledgeable and practiced candidate to drive all manufacturing and technical operations.  This is a critically important role and company will pay generously to attract and retain the right candidate.

Key things to note:

• This company has several marketed products, two near-term launches and a rich pipeline – primarily small molecule.  Broad and deep knowledge of small molecule manufacturing best practices will be essential.
• This company outsources production, lab, packaging, etc. to third-party vendors (both domestic and international).  Extensive experience managing manufacturing and technical operations in an outsourced/virtual setting is required.
• This Executive Director will lead manufacturing and tech operations from development through commercialization.  Strong background in tech transfer and scale-up is expected.
• This is an emerging company in building mode.  Right candidate will be process improvement-oriented, innovative, analytical, industrious and hands-on. 
• This ED will supervise a small team, as well as oversee the work of CMOs and other vendors.  We seek a skilled manager of people and process.
• This ED will represent the company with vendors, partners, regulatory authorities, etc.  Technical capabilities must be complemented by exceptional professionalism, leadership and communication skill.
• Travel expectations of up to 25%, including some international travel.

Specific duties will include:

• Oversee activities for drug substance, drug product, and finished goods for commercial products from approval through process validation
• Provide technical support for commercial products. Contribute to product design
• Provide launch planning and commercial estimates for new products in partnership with Commercial stakeholders
• Lead technology transfer of new and existing commercial drug product, and finished goods manufacturing processes to contract manufacturing organizations
• Develop validation and product life-cycle strategies and plans for each commercial product & process
• In partnership with Quality and CMOs, conduct risk assessments on commercial manufacturing processes and develop risk mitigation plans
• Working with project-based CMC teams, contribute to areas of process and product development strategy
• Participate in vendor/supplier selection business processes and make strategic recommendations on commercial manufacturing sites
• Review the CMC sections of new NDAs and author CMC sections of post-approval changes
• Assess and communicate the status and scalability of manufacturing processes for registration, commercial, etc.
• Communicate with project and functional teams, present alternate paths forward, identify and evaluate gaps and provide recommendations
• Author, review and/or approve deviation and investigation reports, change controls, and corrective/preventative actions. Manage interactions with Quality and Regulatory organizations to ensure speedy resolution of manufacturing and product related technical issues in facilitating product releases
• Partner with CMO organizations to manage process lifecycle, develop process improvements and cost efficiencies.

Selected candidate will offer a related scientific or engineering degree and 10+ years in increasingly responsible roles in pharmaceutical manufacturing operations.  Broad and deep knowledge of FDA, ICH, USP and cGMP regulations, guidelines and practices are assumed and essential.  Other priorities include:

• Extensive experience overseeing CMOs and other third party vendors in a high expectations setting
• Broad and deep knowledge of tech transfer and scale-up, with particular expertise in small molecule processes
• Familiarity with sterile manufacturing and finished goods packaging processes
• Keen analytical skills complemented by a process improvement mindset
• Outstanding project management and process management skills
• Ability to travel internationally
• Longevity and impact in previous roles

Finally, we seek a hands-on leader with a history of developing positive, symbiotic and productive relationships with internal and external stakeholders.  This is an exciting time at a very exciting company.  We seek a contributor and a collaborator who will thrive.

Local candidates targeted at this time.  Please forward Word resume for prompt consideration.