Provides the specialist knowledge, as Subject Matter Expert, of the Cell and Gene Therapy product specific analytics and Quality Control, supporting the late-stage clinical manufacturing, launch and commercial lifecycle at external contract manufacturing organizations (CMO) and external testing facilities (vector products and autologous T-cell products).
Oversees processes and standards to maintain and improve existing analytical technologies. Ensures seamless flow of knowledge and information across functions, and sites, with focus on the analytics.
Support/lead deviation, investigation and change control management of CMO. Supports the oversight on product’s quality attributes, ensuring analytics are robust, comparable, in compliance to cGMPs, in continued state of validation and continuously improving.
Major accountabilities:
Technology Transfer / Method Validation:
•Performs evaluation of analytical methods being transferred to or from the site by utilizing a risk-based approach.
•Designs, plans and executes activities related to the transfer and validation of in-process, release and stability methods for Cells and Gene therapy products, using a broad range of analytical platforms per ICH (International Committee of Harmonization) guidelines and other FDA / EMA / PMDA guidance if available.
•Performs Quality Risk Assessments and generates / reviews other technical documentation including analytical development reports, transfer protocols, validation protocols, validation and technical reports, technical memos.
•Performs comparability evaluations to support process changes and performs product characterization studies.
•Leads/supports transfer of analytical methods to other Novartis sites, CMOs and write Transfer report on existing knowledge, through the appropriate documentation and supporting at the receiving site as needed.
Deviations and Investigations/improvement on product:
•Initiate, support and/or lead deviation and investigation handling in alignment with respective quality systems.
•Initiate and/or support CAPA and other improvement projects (quality, efficiency), involving cross-functional teams.
•Actively participate and represent their product(s) in the relevant committee, where the improvements on weak point of analytical methods are planned and monitored.
Change control:
•Participate and/or lead (case by case) the change controls to its products and related processes across sites. Execute and assure respective change control activities in alignment with respective quality systems.
•Ensure alignment of (regulatory) timelines for technical changes (transfers or launch, major deviations.
Support of Quality Control and other partners
•Assists QC and Quality Assurance in investigations of assay-related issues and recommends solutions.
•Provides analytical support to internal MS&T and other partners as needed
•Perform trending analysis for Reference materials, Controls and Critical reagents.
•Build libraries of atypical data along with the results of their investigation findings.
•Prepares data, performs the data integrity auditing and contributes to regulatory submission documents
Continued Process Verification (CPV), data trending and statistical analysis:
•Support the CPV program monitoring of critical variables and key variables as appropriate for the assigned product(s) (Critical Process Parameters CPP, In Process Control IPC parameters, Quality Attributes, Characteristics of raw materials), through regular product specific data trending.
Testing Monograph support:
•Ensure oversight on Testing Monograph, liaising with Analytical teams to ensure consistency of content.
Training:
•Ensures with local organization compliant training status of respective site associates
•Own the Training Curriculum for its Job Profile and organizes respective training .
Audit support:
•Maintain their work in inspection readiness level and to provide the necessary support in any internal or external audit.Minimum requirements•MSc or equivalent in Analytical Chemistry, Cellular Biology, Immunology, Biotechnology, Biochemistry, Chemistry, Microbiology, Pharmacy or other Life Science-related scientific degree.
•Desirable: Advanced degree in a scientific or relevant discipline (Ph.D. or equivalent)
•Fluent in English and good knowledge in site local language.
•Experience in Bio-Analytical method development , Quality Control or a technical support function (FACS and/or qPCR technology)
•Minimum 7 years of industrial GMP experience in analytical method development and/or QC analytics of cellular therapies or or biological products
•Demonstrated knowledge and skills in multiple analytical techniques
•Expertise in ICH and FDA/EMEA analytical GMP requirements
•Minimum 7 years experience in manufacturing or laboratory role.
•Strong interpersonal skills and ability to effectively lead and influence without formal authority
•Sound Project Management & Presentation Skills
•Proven understanding of pharmaceutical cGMP and regulatory aspects of biological and sterile products.
•Knowledge of statistical tools and methods
•Strong verbal and written technical communication skills
•Strong interpersonal skill
•Sound experience of data handling and applied statistics.DivisionNovartis Technical OperationsBusiness UnitNTO BTDMLocationSwitzerlandSiteBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaTechnical OperationsJob TypeFull TimeEmployment TypeRegular
