Sr. Scientist (Upstream / Downstream Optimization)

Company: CSL Behring
Location: Holly Springs
Posted on: January 12, 2022

Job Description:

Job DescriptionJob Purpose:The individual serves as a subject matter expert responsible for oversight of influenza candidate vaccine virus strain (CVV) optimization, upstream and downstream processes. This includes direct leadership/oversight of the TD Late Stage Development CVV optimization scientific teams towards the delivery of fully optimized strains for influenza commercial vaccine manufacture.-- -Major Accountabilities:1.-- - Process and Product Development:Represents TD Late Stage Development on cross-functional/departmental teams related to influenza cell culture-based commercial campaign preparedness.Interphases with Manufacturing, Operations, MS&T and other relevant functions to optimize antigenically relevant candidate vaccine viruses (CVVs) for the manufacture of influenza vaccines.Provides leadership, guidance and Design of Experiment (DoE) expertise to staff directly responsible for all aspects of optimization of down selected lead influenza CVVs.In collaboration with the direct supervisor and TD Late Stage team leads, facilitates high throughput optimization of down selected CVVs to achieve maximal campaign readiness.Interfaces with Pilot Plant team to facilitate seamless transition of infection optimized strains into assessment of pilot scale manufacturability and optimization of Downstream process parameters.Proactively identifies process improvement opportunities to increase reproducibility, modelling accuracy, and improve efficiency.Oversees the characterization and optimization of pre-pandemic influenza candidate vaccine viruses.Uses a data driven approach to progress TD Late Stage deliverables for ongoing influenza vaccine campaign readiness.Responsible for using and maintaining appropriate scientific knowledge to support site/global projects.Provides leadership, guidance and prioritization to staff directly responsible for execution of optimization experiments of antigenically relevant influenza CVVs.Maintains knowledge of influenza surveillance in the context of risk to vaccine strain change.2.-- - People Management: Direct supervisor for two scientific teams Upstream/Infection Optimization and Downstream/Splitting Optimization.Provides ongoing performance feedback and development to direct reports; provides periodic feedback to indirect reports and ensures development opportunities are afforded to all team members.Provides scientific/technical and experimental design guidance and mentorship to TD Late Stage teams.Models a culture of safety, ensures team adheres to requirements, and identifies and implements improvements.Maintains a state of compliance for team through regular review of training and implementing training curricula improvements.Serves as subject matter expert and general scientific resource for colleagues with less experience.3.-- - Operations/Quality Support:Serves as an interface between TD and Operations by representing TD department in cross-functional forums and informing stakeholder of key information to support manufacturing.Utilizes knowledge and experience of virology, cell culture, DoE, bioprocessing, etc. to provide technical support for production of drug substance in GMP manufacturing.Performs regular/periodic review of SOPs, process descriptions, work instructions, etc. related to area of expertise to ensure consistency with current business practices.Uses scientific and statistical knowledge to support product, process and testing related investigations and deviations including compliance, deviation, OOE and OOS investigations that require support TD.4.-- - Additional Duties: Generates data summaries and presents project progress for key stakeholders in other functions (Operations, MS&T, QC).-- -Completes all individual training and maintains a state of compliance.Monitors training compliance of direct and indirect reports to ensure a state of compliance is maintained.Adheres to all safety requirements, models highest standards of safety and holds own self and team accountable.Minimum Qualifications:PhD in Virology, Molecular Biology or related field strongly preferred.Minimum of 5 years relevant industry experience and/or equivalent experience in a relevant academic environmentPrevious experience managing a scientific team of direct reports requiredKnowledge of statistical techniques such as Design of Experiments (DOE) is required.Previous experience with handling and cultivation of mammalian cell culture required; bioreactors and liquid handling systems strongly preferred.Previous experience with upstream and downstream processing strongly preferred.Previous experience working with viruses and vaccine development strongly preferred.Knowledge of aseptic operations experience and biosafety level 2 and biosafety level 2 enhanced strongly preferred.About 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 benefits 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 Seqirus.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 Diversity, Equity & Inclusion at Seqirus.Do work that matters at Seqirus!

Keywords: CSL Behring, Cary , Sr. Scientist (Upstream / Downstream Optimization), Other , Holly Springs, North Carolina