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Senior Director, PDP

Company: Emergent BioSolutions Inc
Location: San Diego
Posted on: April 9, 2021

Job Description:

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Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. Position Summary The Sr. Director, Process Development and Production (PDP) will be responsible for process development, clinical trial material production, and technology transfer to the commercial manufacturing site. This position will be involved in Emergent's various viral, virus-like-particle (VLP) and nanoparticle vaccine development programs, which includes cell culture, viral amplification/VLP transient transfection, chromatography purification and diafiltration/ultrafiltration processes. This position will manage several teams: upstream process development, downstream process development, manufacturing engineering, cell line development, assay development and clinical production teams to efficiently complete the vaccine process development and clinical production work. Additionally, this role will support IND and BLA CMC sections and all internal and external audits. Essential Functions Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

  • Successfully manage and direct the activities of the Process Development & Production group.
  • Provide leadership and technical expertise in support of vaccine development and clinical production.
  • Mentor and support the professional development of team members.
  • Lead cross-functional teams and coordinate with Analytical Development, Product Development, Quality Assurance and Project Management teams, in an effort to complete the development and clinical production work efficiently.
  • Responsible for PDP planning, and multi-year resource forecast.
  • Lead cGMP activities (facilities, personnel, equipment, processes, and procedures) compliant and efficient.
  • Write and review investigational new drug (IND) and BLA CMC section.
  • Evaluate and manage CMO/vendor activities.
  • Support internal and external audits.
  • Support FDA and EMA agency related meetings. Minimum Education, Experience and Skills
    • Minimum of 15 years' relevant industry experience with an M.S degree or 10 years' experience with a Ph.D. degree.
    • Master or Ph.D. of Science/engineering in Biology, chemistry, chemical engineering, or related discipline is preferred
    • Understanding of mammalian cell culture and downstream purification process development and scale up is a must.
    • cGMP experience is required.
    • Experience in vaccine research, development and clinical production is required.
    • Experience of IND and BLA CMC section writing is preferred.
    • Experience of FDA and EMA meeting and communication is preferred.
    • Experience with live virus and virus-like-particles is preferred.
    • Exceptional leadership skills and proven ability to interact effectively with all levels of organization.
    • Excellent management and communication skills. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.-- Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
      -- Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
      -- Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .
      -- Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. ABOUT EMERGENT Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life. Our drive towards this vision informs all of our actions-whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community-we strive every day to achieve this shared goal. WE BELIEVE IN OUR VALUES
      • Stand shoulder to shoulder no matter what
        • We combine our best thinking and communicate openly to support each other.
        • Break through thinking
          • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
          • Own it always
            • Every person at Emergent is engaged and accountable for delivering on our commitments.
            • Compete where it counts
              • We set the right goals and respect each other as we conquer them together.

Keywords: Emergent BioSolutions Inc, San Diego , Senior Director, PDP, Executive , San Diego, California

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