Durham, North Carolina

This Position is Fully Grant Funded

School of Medicine:

 

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

 

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

 

Sr. Director, GMP Program

 

This position will be responsible for leading all aspects of the production of complex vaccines and/or monoclonal antibodies for use in human trials in grants and contracts awarded to DHVI. Experience in and/or in-depth knowledge of the CGMP production of biologics (e.g., fermentation, cell culture, purification) and a strong background in CGMP Quality Systems is essential. Previous experience in the oversight of GMP production of recombinant proteins and/or mRNA products required. Specifically, the successful individual should have familiarity with CGMP upstream and downstream plus all relevant QC/QA oversight and have 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. An understanding of cost management is required. This is a critical leadership position that will play a major role in the development of new vaccines and/or monoclonal antibodies for use in protecting or treating those with infectious diseases such as HIV, Influenza, SARS-CoV2, and TB.

 

RESPONSIBILITIES:

 

Administration

 

  • Provide strategic planning in the development of vaccine products for early phase clinical evaluation
  • Oversee pre-production and GMP execution of CGMP programs and work with discovery teams to speed new product development
  • Collaborate with the heads of GMP Operations, Process Development, Quality Assurance, and Analytical Development to direct efficient product development
  • Oversee the Duke Human Vaccine Institute CGMP Operations. This includes:
    • Providing exceptional leadership skills to the organization including hiring, mentoring and developing staff
    • Using strong communication and teamwork skills to build strong relationships with stakeholders
    • Demonstrating 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
    • Oversite of 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
    • Champion a progressive culture of world class CGMP Manufacturing Operations
    • Drive efficient, cost effective operations 
    • Establish robust scheduling systems to maximize use of facility and staff
    • Work with key stakeholders to develop execution plans to increase capacity and throughput of operations
    • Work with Quality Assurance to ensure CGMP compliance in personnel training, documentation, and operations
    • Champion the implementation of new technologies and systems
    • Ensure a culture of strong CGMP compliance
    • Work with Director of GMP Operations to 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
    • Collaborate with regulatory team to develop pre-IND, IND, and IB documents
  • Business and Financial
    • Develop and manage annual operating budgets for all CGMP Operations 
    • Provide leadership in the development of strategic manufacturing plans
    • Oversee the fiscal aspects of the product development / CGMP functions
    • Ensure the levels of financial and people resources align with the current portfolio and strategically plan for future financial and human resource needs

 

 

Business/Product Development

 

  • 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.
  • Oversee the 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.
  • Assist in the negotiation and execution of 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.

 

 

QUALIFICATIONS:

  • 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

 

Required Qualifications at this Level

 

Education/Training: Work requires a Bachelor's degree in Business Administration, Hospital Administration, Accounting or a closely related field.

Experience: Work requires a minimum of nine years progressively responsible experience in administrative management, to include proficiency in budgeting, grants and contracts, personnel supervision and space and facilities management. A Master's degree in Business Administration, Hospital Administration, Accounting or a closely related field may substitute for two years of required experience. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

 

 

 

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

 

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

 

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

 

Durham, North Carolina

As a world-class academic and health care system, Duke Health strives to transform medicine and health locally and globally through innovative scientific research, rapid translation of breakthrough discoveries, educating future clinical and scientific leaders, advocating and practicing evidence-based medicine to improve community health, and leading efforts to eliminate health inequalities.

Similar jobs