Job: Sr. Director, GMP Program - 154670, Duke Human Vaccine Institute, Durham, NC
This position will be responsible for leading all aspects of the production of complex vaccines and/or monoclonal antibodies for use in human trials. Experience in the CGMP production of biologics (e.g., fermentation, cell culture, purification) and a strong background in CGMP Quality Systems is essential. Specifically, the successful individual should have CGMP upstream and downstream experience plus all relevant QC/QA oversight and having had success in gaining an IND for a biological product. Specific vaccine production experience preferred. Upstream work using 293 and CHO (CHO S or DG44) cell lines in transient and stable transfections desired with downstream experience using affinity (i.e., monoclonal) and non- affinity approaches to purify proteins from cell lines noted above. Experience in using wave bag or other modular approaches to growing cells for protein production is highly desirable. A good understanding of cost management is required. This is a critical leadership role that will play a major role in the development of new vaccines and/or monoclonal antibodies for use to protect or treat those with infectious diseases such as HIV, Influenza, SARS-CoV2, and TB.
• Oversee pre-production work on projects and work with discovery teams to speed new product development
• Oversee new development work in the Gates/DHVI Protein Production Facility.
• Administer the Duke Human Vaccine Institute CGMP Operations. This includes:
o Provide exceptional leadership skills to the organization including hiring, mentoring and developing staff
o Use strong communication and teamwork skills to build strong relationships with stakeholders
o Demonstrate outstanding technical acumen, operational understanding and CGMP compliance in building and running the Operations Department
• Provide senior leadership in the management of the CGMP Manufacturing facility for the production of CGMP materials
o Develop and maintain all necessary CGMP systems including SOPs, Deviation Management, Change Control, CAPA, etc. in collaboration with existing quality management and regulatory teams.
• Lead an exceptional Operations team to run CGMP Manufacturing Operation. This includes
o Champion a progressive culture of World Class CGMP Manufacturing Operations
o Drive efficient, cost effective operations.
o Establish robust scheduling systems to maximize use of facility and staff
o Work with key stakeholders to develop execution plans to increase capacity and throughput of operations
o Work with Regulatory and Quality Control functions
o Champion the implementation of new technologies and systems
o Ensure a culture of strong CGMP compliance
o Ensure that production facilities are maintained at a high standard, equipment maintenance and calibrations are performed and validation protocols and reports are reviewed and approved.
o Ensure all staff maintain appropriate level of training
o Lead IND and IB development
• Business and Financial
o Develop and manage annual operating budgets for all CGMP Operations
o Provide leadership in the development of strategic manufacturing plans
• Continuously advance product development competencies at DHVI, as needed to support DHVI goals by providing business development functions.
• Provide strategic input and direction to the DHVI Leadership on business development and related issues for DHVI interactions with industry. Establish a project steering and management group and organize and provide support to this group.
• Develop core competencies in product development at DHVI by performing duties and training, mentoring, or developing staff either directly or indirectly.
• Develop summary and fact sheet of each agreement and monitor the milestones of agreements and commitments
• Assist DHVI Leadership in the development and execution of the partnering strategy with external groups. Leverage industrial and business perspectives processes and contacts and blend with academia to progress DHVI translational science mission.
• Maintain deep understanding and current awareness of the DHVI scientific portfolio and business strategies. Provide enterprise visibility into program and project portfolio performance and enterprise resource management.
• Represent DHVI interests to external stakeholders by identifying and evaluating potential partnering opportunities, conducting due diligence, and presenting opportunities to the DHVI Leadership that help achieve the DHVI strategic objectives.
• Maintain external relationships with broader vaccine development, and financial community to ensure DHVI awareness and access to innovations, development techniques, and technologies as appropriate to accomplish its mission.
• Work with and coordinate broad cross-functional teams in preparation of presentations to potential partners, preparation of due diligence as well as managing the team in the various interactions with potential partners throughout the deal process.
• Manage the development of the business case and financial model with other internal functions, as well as manage the overall assessment of potential partnering opportunities.
• Prepare and deliver presentations to DHVI Leadership integrating and summarizing scientific, clinical, financial, and market information as well as recommend ways to structure active partnerships.
• Negotiate and execute partnering agreements across a broad range of deal structures. Assist in the structuring and negotiation of term sheets and subsequent licensing agreements with potential business partners. Participate in drafting and reviewing contracts that cover a broad range of collaborative agreements.
• Interface with funders and FDA as needed.
• PhD is highly preferred in relevant Science or Engineering discipline; MBA a plus
• 10+ years of experience (including 5+ years in a senior management role) in CGMP operations.
• 5+ years of business development experience in the biologic / vaccine industry with an established track record of successfully establishing collaborations with industry and academic partners
• Strong knowledge of CGMP compliance and CGMP manufacturing operations with background in Protein Biologics in a CGMP Manufacturing environment required
• Strong strategic and analytical skills including deals analysis with hands-on experience in structuring and negotiating business development, contracts, and licensing transactions.
• A good understanding of finance required, including previous experience managing complex budgets
• Relevant business experience within a pharmaceutical/biotech company or related business
• Strong interpersonal and communication skills for bridging scientific and business participants for effective internal collaboration as well as for interactions with potential partners
• Sound business judgement with the ability to synthesize and summarize a complex set of facts and set opportunities within the broader strategic context
• Demonstrated leadership experience with strong understanding of drug discovery and development process
• Comfortable with public speaking and delivering presentations
• Proven project management abilities with demonstrated experience building and leading exceptional teams