Director, CMC Recombinant Protein Development

Position Summary:  

IAVI is seeking a highly motivated and energetic candidate for mid- to senior- level position within IAVI’s Chemistry Manufacturing and Controls (CMC) team. Position levels could be adjusted for appropriate level of experience and training. Successful candidates will be responsible for strategic planning, coordinating, and execution of the recombinant protein process development / characterization activities, as well as oversight of contract manufacturing organization(s) for process development, including associated scale-up, process optimization, technology transfer, manufacturing, and release and stability testing. Candidates should have prior industrial experience in product development of biologics (e.g., recombinant protein, monoclonal antibodies). The Primary responsibility of the Director is to support the Chemistry Manufacturing and Controls (CMC) aspects relevant to the development of Monoclonal Antibodies/biologicals for prophylactic or therapeutic use in human.

The Director CMC will work closely with the Senior Director, Product Development and Manufacturing (R&D) for undertaking developability assessment, cell line generation, process (upstream, downstream and formulation) and analytical test method development. In close interaction with the Senior Director R&D and project team, the Associate Director/Director CMC will also oversee cGMP manufacturing of monoclonal antibodies/biologicals at Contract Manufacturing Organization (CMO).
 

Job Title:         Director, CMC Recombinant Protein Development

Location:         IAVI Headquarters, New York, New York, USA

Reports to:      Senior Director, Product Development and Manufacturing (R&D)

Key Responsibilities:

  • Participate within the Product Development Project teams and develop technical work plans through different phases of development through to cGMP manufacturing and product release for pre-clinical & clinical studies.
  • Participate in feasibility assessment/risk assessment of developing recombinant proteins/biologicals.
  • Participate in the selection of Contract Research Organizations (CROs) & Contract Manufacturing Organizations (CMOs) for generation of high expression cell lines, cGMP manufacturing and release and stability testing of monoclonal antibody candidates within the R&D portfolio as per Regulatory requirements.
  • Familiar with negotiating contracts with the CMOs & CROs along with the Legal, Business Administration, Grants/Contracts & Compliance and QA departments.
  • Establish operational work-plans with the CMOs & CROs and provide an oversight on the program progress with an emphasis on maintaining timelines and budget, working closely with the project team. 
  • Possess strong technical capabilities for trouble-shooting on issues related to process and analytical method development of monoclonal antibodies/biologicals, cGMP manufacturing and testing.
  • Familiar with development of monoclonal antibodies/biologicals, consistent with International Standards e.g. ICH, US FDA and EMA requirements
     

Education and Work Experience:

  • A Doctoral Degree (Molecular Biology/Biochemistry/Pharmaceutical Sciences) or Industrial Engineering Degree with >7 years of experience of working in biotechnology/biopharmaceutical industry.
  • A strong background in cGxP (e.g. cGMP, cGLP) and working in an FDA Regulated Environment (Pharmaceuticals or Biologics) for developing high expression cell lines, undertaking process & analytical development & cGMP Manufacturing of biologicals for pre-clinical and clinical evaluation is required. 
  • Experience in process and analytical development of biologicals with clear demonstration of product development expertise and CMC knowledge is highly desirable.
  • A minimum of 2-3 years of applicable/direct managerial experience is desirable.
  • Sound technical understanding of biological development and knowledge of Quality Assurance (QA) considerations for cGxP activities.
  • Excellent (oral and written) communication and interpersonal skills with (a) proven record of working in a multi-cultural environment, and (b) proven ability to influence and generate consensus.

Work Environment and Physical Demands:

The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

  • Mobility to perform the essential functions of the position
  • Hearing and speech sufficient to verbally communicate in person and on the telephone constantly (66-100%)
  • Typical office environment
  • Occasional travel off-site for team meetings with collaborators, as needed (up to 20%)
  • Ability to travel to IAVI offices in New York  

Other Duties:

  • Perform other duties as assigned

Organizational Overview:

The International AIDS Vaccine Initiative (IAVI) is a nonprofit scientific organization whose mission is to translate scientific discoveries into affordable, accessible public health solutions to help the people who need them the most.  Since its founding in 1996, IAVI has provided scientific, research and development, and policy leadership to address the needs of communities and key populations at risk for HIV infection around the world. IAVI works with more than 100 academic, industry, government, civil society, clinical, and community partners in more than 25 countries. IAVI is committed to supporting the broad field of HIV vaccine research and to fostering collaborations that accelerate the development and availability of new prevention tools. In pursuit of our goals, we work to catalyze and support novel partnership models that engage partners from both the public and private sectors across the product development continuum.

IAVI’s global reach, including its clinical research network in five countries in sub-Saharan Africa and in India, has allowed IAVI to make fundamental contributions to understanding of the epidemiology, transmission, natural history, virology, and immunology of HIV infection. This work played a key role in facilitating the structure-based design of promising HIV vaccine candidates as well as the discovery of “broadly neutralizing antibodies” that are now being advanced as promising approaches for HIV prevention. IAVI’s integrated capabilities in vaccine discovery, development, and clinical research take advantage of biopharmaceutical industry expertise to accelerate the development and testing of novel HIV vaccine candidates.

In addition to its core HIV vaccine effort, IAVI is working to amplify its global health impact by working with partners to address other urgent unmet public health needs – such as vaccines for other infectious diseases – where our existing technologies, assets, and experience can add unique value.

IAVI Core Values

Dedication to the Mission:  We are committed to the translation of scientific discoveries into affordable, globally accessible public health solutions.

Innovative Evolution:  We are committed to solving complex problems in creative and innovative ways, learning from our mistakes and successes and never giving up

Integrity:  We are committed to meeting the highest ethical and professional standards in everything we do and to taking responsibility for our actions to earn respect

Collaboration:  We are committed to embracing diversity, the power of glocal teamwork and the belief that by working as one we can make a difference

 

 

Leadership and Communication

 

  • Proactively ask questions to understand organizational strategy and performance objectives
  • Come up with new and unique ideas to achieve objectives
  • Take proactive steps to collaborate with members from other teams/departments
  • Seek solutions to a system/process failure
  • Positively handle criticisms, complaints, and special requests
  • Directly communicate with manager, peers and team members

Disclaimer:  Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.  The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position.  They are not intended to be an exhaustive list of all duties, responsibilities and skills required of personnel so classified.  This document does not create an employment contract, implied or otherwise, other than an “at-will” relationship.

All IAVI employees are expected to follow and abide by the legal, financial, regulatory, safety, and other general guidelines of IAVI, and to conduct their activities in a manner consistent with the highest personal and professional standards.

IAVI is an equal opportunity employer and applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.