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.