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Scientific Associate II/ Scientist I (Cell and Molecular Analytics)

Company: CSL Behring
Location: Holly Springs
Posted on: May 14, 2022

Job Description:

Job Description Job Summary
The successful candidate will lead the efforts towards the development of cell-based methods for potency assessment of seasonal and pandemic sa-mRNA drug products as per current regulatory (FDA, USP, etc.) guidance and industry standards. As a key member of the Analytical team, you will be contributing directly as hands-on experiments, independent analyses, and interpretation of the data. This role will interact closely with our process development and QC teams and lead documentation activities for CMC-analytics related to tech transfer to QC. To be successful in this role, you must be able to provide sound scientific solutions, communicate clearly (in verbal and written form), engaged to work collaboratively within team and cross functionally to deliver exceptional results and ensure long-term success. Additionally, this role would provide analytical assay execution in support of vaccine process and product development programs, including LNP potency assays as needed for the Cell and Molecular Analytics team.

Principal Accountabilities
Development Work:

  • Potency method development for drug products using various cell-based assays and establish acceptance criteria for evaluation and monitoring method performance
  • Monitor performance of methods that are in operation both internally and at external laboratories through trending of assay QC data; detect and solve method performance issues
  • Review and preparation of new and revised SOP associated with the functions of the Analytical testing and analysis of sample testing potency data in a scientifically sound manner
  • Preparation of high-quality reports per regulatory guidance on method development and qualification
  • As required, provide analytical assay execution in support of vaccine process and product development programs, e.g. RNA activity, LNP potency, qPCR for process development or process improvements.
  • Perform review of analytical documents, checking for compliance with Good Documentation Practices (GDPs) and Good Laboratory Practices (GLPs)
  • Oversee and coordinate analytical laboratory equipment qualification documents.
  • Oversees and advises on the development of Standard Operating Procedures, Guidelines and other tools to support early phase CTM testing support.
  • Supports the quality and compliance training program; collaborates with operations management to ensure staff training is current as required by their role.
  • Works with TD-QA team as liaison to ensure all quality attributes are in place to support GLP testing.
  • Work with TD-QA to close gaps related to GLP or GxP lab requirements
  • Evaluates procedures and processes affecting quality and proposes process improvements when applicable.
  • Experienced and very knowledgeable of FDA, EMA, and other regulatory regulations.
  • Experienced in managing concurrent complex projects/programs (e.g. process improvement initiatives for lab).
  • Proactively identify development and improvement opportunities
  • Able to work under tight deadlines.
  • Functions effectively as core team member on multiple concurrent projects and leads small projects and establishes work processes.
  • Data collection and reporting with knowledge of GLP/GMP environments.
  • Work closely with the Separation, Biochemistry, and Molecular and Cellular Biology groups within TD-Analytical to provide technical expertise for GLP/GxP requirements or lab support for process improvements or assay development support.
  • Provide support on reviewing documentation in notebooks and reviewing data in LIMS for specific lab based processes that the employee is trained on.
  • Interface with electronic business systems (e.g, LIMS, SAP, EDMS)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 with analytical techniques used in biopharmaceutical (i.e., vaccines) process development and 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 for development work
    • Generates a supportive business case, and supports cross-functional teams to deliver those opportunitiesPeople Management:
      • Provides guidance to new team members, interns and students and acts as a resource for colleagues with less experienceOther:
        • Completes individual training and maintains a state of compliance
        • Adheres to all safety requirements
        • Supports communication/updates as required Project Work
          • This position will support various projects to deliver the TD portfolio of work as required and defined in the annual objectives or through agreement with direct line manager.Scope/Accountability
            • Accountable for own contribution to technical development activities relating to the technical success of low to moderately complex projects at a site level
            • Scale of technical contributions impact success of projects and adherence to budget at team level
            • Functions effectively as a core team member on multiple concurrent projects and leads small projects and established work processes
            • Provides guidance to new team members, interns and students and acts as a resource for colleagues with less experience
            • May provide direct supervision to less experienced colleagues or technical support associatesImpact/Influence/Liaison
              • Medium level of influence both internally and externally relating to assigned products/projects
              • Ability to negotiate with internal and external stakeholders
              • Delivers a range of customer, operational, project or service activities
              • Functions effectively as a core team member on multiple concurrent projects including representing TD and ensuring TD deliverables are provided for projects involving functions outside of TD and leads small projects and established work processes within TD
              • Explains complex or technical information to others
              • Effectively presents results in internal meetings and may participate in external meetings
              • Collaborates effectively with others in large, complex project initiatives
              • Aware of the workings of the business beyond own team
              • Works in disciplined fashion with others to deliver team and organizational results
              • Technical expert resource within own discipline for functionKey Relationships
                • Internal: coordinates individual work with members of other TD teams and other functions at the site level (QA, QC, SC, RegsCMC, etc.), limited interactions with TD and other functions within R&D, Operations and Quality at other sites in Seqirus and CSL globally
                • External: interacts with Vendors/suppliers to obtain goods and services, limited interaction with colleagues in the field (e.g., at conferences or through collaborations), may participate in discussions with regulatory bodies to explain own work
                • Develops network of internal colleagues (primarily site based) to share scientific knowledge, projects and best practices
                • Collaborates within and across teams to break down barriers, comfortably voicing own opinion
                • Listens attentively to determine unstated needs, verifying messages and clarifying expectationsDecision Making
                  • Solves complex problems through collaboration with others, taking a new perspective on existing solutions and utilizing technical experience, judgment and precedents
                  • Has autonomy to propose alternatives and exercises judgment based on experience; normally follows a specified course of action
                  • Analyze available information along with experiences of self and others to make non-routine, more advanced decisions
                  • Focuses on making accurate and effective decisions in all types of situations, analyzing results to understand outcomes and adapting approach based on past learnings
                  • Delivers support to others across teams or function, initiating dialogue and fostering cross-team exchange of ideas and informationInnovation
                    • Solves complex problems through collaboration with others, taking a new perspective on existing solutions
                    • Conducts independent research, development or support programs; generates internal or external documents (e.g. publications, patents, regulatory documents) related to own work
                    • Pro-actively engages with colleagues to identify complex areas for continuous improvement and innovation within TD at the site level with some impact on global TD or other functions, develops the change
                    • Searches for information about new technologies and scientific advances
                    • Seeks for 'best practice' rather than maintaining the status quoTravel requirements
                      • Minimal domestic, regional & global travel is required of this role ( Minimum Requirements
                        • Hands on experience developing cell based assays for biopharmaceutical products.
                        • Experience with analysis of RNA is highly desired for support of Analytical Lab Development and assay improvements.
                        • Excellent presentation skills, excellent communication skills, time management, technical writing skills, PC skills, and critical thinking and analysis.
                        • Ability to work effectively in a team environment and with individuals at all levels within an organization...... click apply for full job details

Keywords: CSL Behring, Cary , Scientific Associate II/ Scientist I (Cell and Molecular Analytics), Other , Holly Springs, North Carolina

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