Senior Manager Manufacturing Sciences & Technology

Overview

 Responsible for providing direct support and overall leadership to the manufacturing of Cell Therapy products and may support Master and Working Cell Banks, Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs). Scope includes management of teams responsible for:• Quality systems which include but not limited to investigations/deviations/non-conforming events, action plans, CAPAs, change controls and protocols• Technical support and troubleshooting of routine manufacturing• Technical investigations, CAPA/Action Plan, Change Control leadership• Process technology transfer• Process issue resolution, improvement, optimization and life cycle management• Process monitoring, trending, comparability and controls• Support late stage studies, validation, characterization and robustness, production and regulatory filings in support of commercialization efforts

Responsibilities

• Focused support of daily operations following Current Good Manufacturing Practices in the manufacture of Cell Therapy products. May support Cell Banks, Viral Vectors and Gene Therapy products. • Team formationo Build a technical and scientific team focused on supporting and improving operational performance in aspects of process and human performanceo Develops team technically, to investigate using various tools, with verbal and written communication and with lean and six sigma methodologyo Staff, train, coach and develop employees within area of responsibility. o Develop processes to manage metrics as a means to monitor and improve performance o Recommends hire/transfer/promotion/discharge and salary changes and acts on problems of direct reportso Conducts employee performance appraisals in a timely and objective manner

• Quality Systemso Reviews quality systems to ensure compliance, robustness and to identify areas of opportunity for coaching and improvemento Participates, coaches and may lead complex quality system performanceo Develops systems and metrics to coordinate and communicate in order to execute quality systems of good quality that meet time expectations o Prepared to present quality systems during regulatory inspections and audits• Technical supporto Develop a team that provides technical support with routine manufacturing, aids in troubleshooting through process monitoring, trending and risk identification and process improvement to achieve safe, compliant and cost effective production to deliver upon client contractso Provides leadership to a team that leads complex technical investigations, CAPA/action plans and change controlso Provides support to late stage programs in support of commercialization efforts.o Supports commercial programs through the performance of process monitoring, trending, comparability and controls, issue resolution, improvement, optimization and life cycle management• Process technology transfero Partners with Process Development, client and other internal and external stakeholders in support of Manufacturing in the evaluation of incoming client projects/program to WuXi and from Process Development to Manufacturingo Helps support Manufacturing in the enhancement of service offerings• Accountable for departmental and performance management • Regularly holds 1:1s with direct reports and skip level meetings • Regularly holds staff meetings • Identifies and prioritizes escalations • Evaluates, recommends and makes decisions on hires, transfers, promotions and discharges • Demonstrated Lean / Six Sigma knowledge desired • Accomplishes staff results by communicating updated organizational information, job expectations & supporting their work • Plans, monitors, and appraises direct reports including performance competencies, goals & job results • Coaches, counsels, and conducts disciplinary actions • Develops, coordinates, and follows organizational systems, policies, procedures, and follows labor and capacity standards • May be required to work Holidays and weekends • May be required to work Overtime • May be required to work outside of normal business hours • Contributes to the overall operations and to the achievement of departmental goals • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.

Qualifications

• HS Diploma or equivalent required and• 5+ years relevant technical experience and minimum 2 years Managing people • BS/BA in Science related field preferred; or combination of relevant Experience & Education

 

Advanced Therapies, LLC provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.