Reporting to the Sr. Director of Technical Development, you will be responsible for design and implement analytical strategies of all vaccine projects within global analytical development. The incumbent will have broad experience on analytical development, a true strategic thinker, well organized and practical in implementation. This person will drive the analytical control strategy, drive and implementation of QbD practice, support CMC regulatory filing, and serve as the secretary of Early-phase Specification Committee. Responsibilities: You will: 1. Development Work:
- -Leads the development and execution of analytical strategies, plans, and implement QbD practice to CMC development to enable new product and process development for all projects at global level.
- -Uses a data driven approach to drive development deliverables
- -Proactively identifies development and improvement opportunities, generates a supportive business case, and drives cross-functional teams to deliver those opportunities
- -Responsible for using scientific knowledge to lead site/global projects
- Extensive experience and knowledge on new product development and CMC regulatory filing.
- Operations/Quality Support:
- Serves as a primary interface between TD and Research, Regulatory, and Quality. Represents TD in cross-functional forums to support end-to-end new vaccine development until BLA.
- -Utilizes extensive knowledge and experience to provide technical leadership for control and characterization of drug substance and drug product, support manufacturing and QC as needed.
- -Utilizes extensive knowledge and experience authoring and providing technical content for IND and BLA.
- -Uses scientific and statistical knowledge to provide leadership for product, process and testing related investigations and deviations including complaint, deviation, OOE and OOS investigations that require support for development work.
- People Management:
- -Provides guidance and mentorship to less experienced colleagues and team members
- -Demonstrated leadership abilities through project leadership and mentoring.
- PhD or Masters Degree in Biology, Chemistry or related scientific field
- Minimum of 5 years with PhD or 10 with Masters degree
- Applies deep specialized and/or broad expertise and is viewed as a subject matter expert (SME) in analytical strategy, assay development and qualification, as well as QbD practice
- Experience in pharmaceutical development in one or more of various disciplines including (but not limited to) Analytical Chemistry, Biochemistry, Biophysics, Cell & Molecular analytics, etc. Extensive experience on leading analytical projects as well as experience on IND and BLA filing required
- Demonstrated technical leadership. Ability to deal with rapid changes
- Demonstrated Lominger competencies in ethics and values, integrity and trust, decision quality, functional/technical skills, peer relationships, perseverance and problem solving
- Effective delivery of objectives in a complex matrix environment
- Develops effective contingency plans
- Proactively develops solutions to complex and strategic issues
- Effective verbal & written communication skills in a cross functional environment
- Attention to detail
- Excellent project management skills
- Good commercial awareness with evidenced application to technical strategies
- Excellent customer focus with demonstrated management of customer expectations and anticipating customer needs
- Demonstrated ability to take measured risks with overall positive outcome for the business, seeking guidance where required
- Excellent presentation skills
Benefits: Medical, Dental, Vision and Life Insurance your first day of hire. Our Benefits
Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits () you can participate in when you join Seqirus. About Seqirus
Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus () . We want Seqirus to reflect the world around us
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