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Associate Director, Drug Product Development

Company: CSL Plasma Inc.
Location: Holly Springs
Posted on: February 23, 2021

Job Description:

Associate Director, Drug Product Development Seqirus USA - NC - Holly Springs Come join a company that tackles fascinating problems and find solutions to complex challenges. With deep expertise in influenza science, our team works on cutting-edge research, pioneering technologies to optimise the manufacturing process and improve the effectiveness of influenza vaccines. We operate as one integrated global organisation, drawing together expert staff from different countries to collaborate. Together, we are working on the front line to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day. Job Purpose: The prospective scientist provides scientific expertise for the design, planning, and execution of drug product development projects. Supports drug product development from early phase to late phase through formulation and process improvements. The individual will provide scientific expertise to ensure studies are well thought out and have clear, measurable benefits. Leads and drives elements of these activities as required. Major Responsibilities: Process and Product Development:

  • Collaborates with R&D senior staff to craft technical strategy for development of new drug products and life cycle management of legacy products
  • Leads drug product development for key strategic projects including adjuvanted and non-adjuvanted flu antigen vaccines and RNA based vaccines
  • Provides technical subject matter expertise in the drug product development space including formulation development, lyophilization, and delivery device design and selection for biologics
  • Oversees drug product development projects through early development stage gates including technical transfer from Research, formulation development, device design and development, and non-clinical and early phase clinical production
  • Author key technical documentation including product and process development plans, contract development and manufacturing proposals, quality target product profiles (QTPP), and technical transfer plans
  • Proactively identifies legacy product improvement opportunities
  • Proactively identifies innovation opportunities in drug product formulation and delivery (e.g. micro-needle patch)
  • Provides technical oversight of product and process development activities sub-contracted to 3rd party development and manufacturing organizations
  • Represent TD on cross functional core project team(s) to provide program oversight, and define and drive program strategy People Management:
    • Drives culture of safety, ensures team adheres to requirements, and identifies and implements improvements
    • Maintains a state of compliance for team and self through regular review of training and implementing training curricula improvements
    • Provides ongoing performance feedback, technical guidance and mentorship to drug product development team
    • Provides project and program level leadership within TD and in cross functional project teams
    • Produce high quality technical presentations for internal audiences including senior management to update on project/program technical progress Operations/Quality Support:
      • Serves as interface between TD and Operations, and represents TD department in cross-functional forums to support manufacturing and QC
      • Utilizes knowledge and experience of drug product processes to provide technical support for production of drug product in GMP manufacturing
      • Uses scientific and statistical knowledge to support product, process and testing related investigations and deviations including complaint, deviation, OOE and OOS investigations that require support TD
        Minimum Qualifications:
        • Bachelor's or Master's Degree or PhD in related scientific field
        • 12+ years with BS, 10+ years with MS or 8+ years with PhD - experience in relevant industry position(s)
        • Broad technical expertise in drug product development including formulation, stability, analytical characterization, lyophilization, and delivery device design and selection for biologics
        • Experience with novel drug delivery technologies (e.g. microneedle patch, nanoparticles) ideal
        • Experience with emulsion chemistry ideal
        • Uses broad and comprehensive technical, scientific or professional knowledge and experience to manage the outcomes and actions of a variety of complex projects
        • Extensive experience in exploratory data analysis and statistical techniques including design of experiments
        • Extensive experience writing content for technical documentation including product and process development reports, regulatory CMC license sections and presentations
        • Excellent communication and interpersonal skills with demonstrated ability to lead, drive and motivate people to achieve goals
        • Demonstrated ability to deliver technical aspects of drug product development projects in a cross functional working environment which includes R&D functions (Research, Reg CMC, R&D QA, Clinical, etc.) and Operations functions (QA, QC, MS&T, Engineering, etc.)
        • Flexible and adaptable attitude with the ability to support change management
        • Role model and promote CSL/Seqirus values
        • Experience managing teams of individual technical contributors (i.e. scientists, engineers) and direct reporting personnel in leadership roles (i.e. manager of managers) Posted 2 Days Ago Full time R-127822 About Us Built on 100 years of experience in influenza, Seqirus is a new global company with an exciting future. It was created in 2015 when parent company CSL Limited acquired the Novartis Influenza Vaccine business and combined it with its own longstanding influenza vaccine operations. Seqirus is currently one of the world's largest influenza vaccine company and a major partner in the prevention and control of influenza globally. It is a reliable supplier of influenza vaccine for Northern and Southern Hemisphere markets and a transcontinental partner in pandemic preparedness and response.-- Seqirus operates state-of-the-art production facilities in the US, UK and Australia, and manufactures influenza vaccines using both egg-based and cell-based technologies. It has leading R&D capabilities, a broad portfolio of differentiated products and commercial operations in more than 20 countries.-- In Australia and the Asia Pacific region, Seqirus is a leading provider of in-licensed vaccines and specialty pharmaceuticals. Seqirus is the sole supplier of a unique range of products made in the national interest for the Australian Government, including antivenoms and Q fever vaccine. Seqirus' parent company CSL is a leading global biotherapeutics company with a dynamic portfolio of life-saving innovative medicines. It operates in over 35 countries with more than 27,000 employees. We invite you to take a look at the many career possibilities available around the globe and consider building a career that --MAKES A DIFFERENC E. Become part of the Seqirus team today! If you are an individual with a disability and need a reasonable accommodation for any part of the-- Seqirus does not accept referrals from employment businesses and/or employment agencies with respect to the vacancies posted on this site. All employment businesses/agencies are required to contact the Seqirus human resources department to obtain prior written authorization before referring any candidates to Seqirus. The obtaining of prior written authorization from the human resources department is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Seqirus. In the absence of such written authorization being obtained, any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Seqirus. Seqirus shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Keywords: CSL Plasma Inc., Cary , Associate Director, Drug Product Development, Executive , Holly Springs, North Carolina

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