The Role

Astellas Gene Therapies is seeking a highly motivated and experienced Senior Analyst to join the Quality Control Technical Support group. The Senior Analyst will be reporting to the Manager, QC Technical Support. This role will be responsible for support testing for methods validation/qualification, method transfer studies and equipment validation. The Senior Analyst will also provide project management, and will support implementing and executing analytical testing in support of commercial viral vector products in compliance with cGMP requirements. This position will be located in Sanford, NC. 

Primary Responsibilities

• This position will support Quality Control through involvement with method qualifications, validations, verifications and transfers, complex analytical and/or manufacturing investigations, method troubleshooting, and project management
• The primary focus of the role will be to serve as the QC single point of contact between transferring and receiving laboratories for laboratory activities associated with new product introduction/transfer, including project management activities such as readiness tracking, transfer schedule development/tracking, and timeline monitoring of documentation review and approval
• Coordinate all laboratory readiness activities for incoming test methods including training materials, SOP creation, initial critical reagent/reference material supply procurement by partnering with teams including the QC South San Francisco (SSF), Enterprise QC and Sanford/SSF groups, as necessary
• Partner with the Sanford QC release laboratories and South San Francisco QC laboratories to co-validate/transfer test methods in support of new product introduction into the Sanford site
• Partner with the biochemistry, bioassay, and analytical QC laboratories to coordinate, manage, and execute assay qualification, validation, verification and transfer activities
• Partner with the validation and facilities/engineering groups to coordinate IOPQ/calibration/maintenance activities/schedules for QC instrumentation/equipment
• Provide oversite to the reference material/critical reagent and standards and controls programs
• Author documents including qualification, validation, verification and transfer protocols and reports, as well as SOPs, training materials and validation/transfer master plans as needed
• Provides analytical technical expertise for manufacturing deviations and OOS/OOT investigations by working concert with Manufacturing and Quality Assurance
• Ensure compliance with applicable cGMP regulations, ICH guidelines, and SOPs, and support regulatory audits

About you

Must Have/Required

• S. degree in chemistry, biochemistry, or related scientific discipline with 6+ years of laboratory experience in a GMP environment
• The successful candidate will need to have a strong analytical and compliance background with proven troubleshooting, investigational and project management skills
• Quality Control and/or Analytical Development experience in the biotech/pharmaceutical industry supporting cGMP areas
• Demonstrated broad knowledge and experience in method qualifications, validations and transfers
• Must be organized and able to manage logistics of multiple projects concurrently
• Experience with method validation deviations, investigations and/or discrepancies
• Experience with Quality Management Systems, LIMS or other Electronic Data Management System
• Strong competencies in planning, project management, and organization with the ability to lead multiple activities; Experience with PM tools such as Microsoft Project a plus
• Established knowledge and application of cGMP, ICH, FDA CMC guidance documents
• Strong analytical and strategic thinking
• Demonstrated problem solving capabilities and cross functional understanding
• Excellent verbal communication (oral, written, presentation) and technical writing skills
• Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion
• Strong interpersonal skills, highly collaborative within a multi-discipline team and contributes to a supportive and positive work environment
• Highly self-motivated and goal oriented
• Models our Core Values: Be Bold: Find a Way, Care Deeply, Get Stuff Done – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted