CambridgeRecruiter Since 2001
the smart solution for Cambridge jobs

Director, mRNA CMC Development

Company: CSL Plasma
Location: Cambridge
Posted on: January 13, 2022

Job Description:

Job DescriptionJob Purpose:The Director mRNA CMC Development is accountable for a team of scientists and engineers responsible for mRNA and LNP (lipid nanoparticle) drug substance process development, and production of GLP/Tox material for pre-clinical studies. - The Director mRNA CMC Development will also be a key contributor to define and drive process and product development strategy, oversee functional laboratory activities, and build and develop a high performing technical team.Major Accountabilities:Process and Product Development:

  • Utilizes technical expertise in process development to define process development strategy for production and purification of RNA, LNP and drug product
  • Leads own multifunction team and collaborates with partner functions (i.e. Research, Analytical Development, Regulatory) to deliver on mRNA process and product development strategy
  • Provides technical subject matter expertise and leads technical teams developing in vitro RNA synthesis, LNP production and purification techniques, and drug product formulations
  • Oversees production of GLP/Tox test articles in compliance with standards and quality requirements
  • Author key technical documentation including product and process development plans, contract development and manufacturing proposals, quality target product profiles (QTPP), and technical transfer plans
  • Writes technical content for CMC sections of regulatory license documents (i.e. IND, BLA)
  • Proactively identifies innovation opportunities for mRNA process and product development
  • Provides technical oversight of product and process development activities sub-contracted to 3rd party development and manufacturing organizations
  • Represent TD on cross functional R&D and Operations leadership teams to provide program oversight, and define strategy, and drive adherence to project plansPeople Management:
    • Drives culture of safety, ensures team adheres to requirements, and identifies and implements improvements
    • Develops multifunction team strategy and structure, recruits' personnel, and builds capability to meet mRNA process and product development program goals
    • 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 mRNA process development and GMP manufacturing teams
    • Provides project and program level leadership within TD and in cross functional project teamsOperations/Quality Support:
      • Partners with Operations to transfer processes into manufacturing, and provides technical support for associated late stage activities (i.e. process performance qualification)
      • Utilizes knowledge and experience in bioprocess development to provide technical support for production of drug substance and 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
      • Produce high quality technical presentations for internal audiences including senior management to update on project/program technical progressMinimum Requirements:
        • Bachelor's or Master's Degree or PhD in related scientific field with 18+ years with BS, 15+ years with MS or 12+ years with PhD
        • Broad technical expertise in mRNA synthesis, LNP chemistry and production, purification unit operation development (i.e. TFF, chromatography), and/or formulation developmentDesired Requirements;
          • Analytical method development
          • Production of GLP/Tox test articles in compliance with quality and industry guidance expectations
          • Exploratory data analysis and statistical techniques including design of experiments
          • Writing content for technical documentation including product and process development reports, regulatory CMC license sections and presentations
          • Proven track record of demonstrating collaboration and influencing skills across the organisation at all levels
          • Demonstrated ability to present complex technical topics to a wide range of audiences with varying technical depth
          • Managing and motivating teams of individual technical contributors (i.e. scientists, engineers) and direct reporting personnel in leadership roles (i.e. manager of managers) across multiple disciplines to achieve complex project goals
          • Demonstrated experience establishing and building a high performing team through recruiting and personnel developmentAbout UsOur BenefitsSeqirus 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 you can participate in when you join Seqirus.About SeqirusSeqirus 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 .We want Seqirus to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about at Seqirus.Do work that matters at Seqirus!

Keywords: CSL Plasma, Cambridge , Director, mRNA CMC Development, Executive , Cambridge, Massachusetts

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Cambridge RSS job feeds