IAVI is seeking an Associate Director OR Director, Analytical Science and Assay Development Viral vaccines to strategize and lead activities for the development of vaccines and biologics candidates important to human health for prophylactic and/or therapeutic use. This leader will address analytical needs of transitioning viral vectors from discovery into clinical testing in an effort to bring solutions to critical global health challenges.
Key Responsibilities:
Advise the relevant internal stakeholders with the FDA, EMA, ICH, WHO, regulatory, and pharmacopeia guidelines and compliance requirements for biologics.
Develop and implement evolving analytical packages that span all the way through from research to a regulated compliance environment (R&D and GXP).
Build assay packages that ensure product CQAs are maintained during expression, purification, and storage of DS and DP of biologics.
Translate research techniques from in-house and external developers into SOPs for tech transfer.
Participate within the Product Development Project teams, developing technical work plans through different phases of development through to cGMP manufacturing and product release to support IND enabling activities.
Collaborate on grant applications, writing grants, and developing budgets to secure funding.
Author and review technical and scientific documents including but not limited to method development reports, qualification/ validation protocols and reports, SOPs, and test methods.
Author and review CMC IND sections for regulatory submission.
Maintain analytical data integrity in compliance with industry good documentation practices (GDP).
Ensure that testing methodologies meet phase-appropriate cGMP requirements.
Work with internal subject matter experts to write and review analytical test method, protocols, and development reports.
Perform any other duties as assigned by the Manager.
Education and Experiences:
PhD in analytical chemistry or a related field is highly preferred; Advanced degree is required.
Educational experience focused on biological analysis is highly preferred.
Minimum 8 years of experience in biologics CMC development with PhD OR minimum of 10 years’ experience with advanced degree required Level to be determined based on expertise and experience in field.
Experience in vaccine development and outsourcing pharma bioanalysis, with an emphasis on virus-based vaccines is required.
Qualifications and Skills:
Experience in cGxP (e.g. GRP, GMP, GLP) is required.
Experience with the testing of Vaccines and Therapeutics, consistent with International Standards e.g., ICH, US FDA and EMA requirements is required; Experience with live attenuated viruses and/or gene therapy vectors highly preferred.
Experience working in an FDA Regulated Environment (Pharmaceuticals or Biologics) for analytical development of cGMP biologicals for pre-clinical, and clinical evaluation is required.
Experience with the development, qualification, and validation of standard analytical tests for viral vaccines (e.g., virus infectivity, qPCR, RT-PCR, SDS-PAGE, western blots, sequencing, Next Generation Sequencing, ELISA) for Late-Stage development is highly preferred.
Experience in developing, qualifying, and validating large molecule analytical methods including HPLC, capillary electrophoresis (CE), and biologics characterization is required.
Experience in writing SOPs and technical transfer and training is required.
Experience developing and implementing an evolving analytical package that spans all the way through from research to a regulated compliance environment (R&D and GXP) is required.
Understands the scientific principles underpinning the critical quality attributes (CQA) of drug substance (DS) and drug product (DP). Experience in building an assay package that ensures that CQAs are maintained during expression, purification, and storage of DS and DP of biologics is required.
Technical understanding of Vaccines and Therapeutics development and knowledge of Quality Assurance (QA) considerations for cGxP activities.
Excellent verbal, written, and presentations skills are required.
Track record of working in a multi-cultural environment with the ability to influence and generate consensus is required.
Apply via :
recruiting.ultipro.com
