Job: Executive Director, Commercial Manufacturing & Technical Operations, Frankel Staffing Partners, Raleigh, NC
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.
Frankel Staffing Partners proudly recruits on behalf of premier employers in the Triangle (and beyond). We specialize in Office Support, Life Science and other Professional Services positions. To view our current openings, please visit our website at www.frankelstaffing.com.