Manager Manufacturing Sciences & Technology
Apply NowCompany: WuXi AppTec
Location: Philadelphia, PA 19120
Description:
Overview
Responsible for providing direct support and 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 formation
o Build a technical and scientific team focused on supporting and improving operational performance in aspects of process and human performance
o Develops team technically, to investigate using various tools, with verbal and written communication and with lean and six sigma methodology
o 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 reports
o Conducts employee performance appraisals in a timely and objective manner
Quality Systems
o Reviews quality systems to ensure compliance, robustness and to identify areas of opportunity for coaching and improvement
o Participates, coaches and may lead complex quality system performance
o 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 support
o 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 contracts
o Provides leadership to a team that leads complex technical investigations, CAPA/action plans and change controls
o 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 transfer
o 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 Manufacturing
o 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
New hires must be fully vaccinated against COVID-19 and provide proof of vaccination or receive an approved medical or religious exemption from Human Resources. This offer is contingent upon WuXi ATU verifying your vaccination status or approving an exemption request prior to your start date. If you wish to be considered for a medical or religious exemption, request an exemption by notifying WuXi as soon as possible, but no later than one week before your start date.
Our Values:
Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.
Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a
dedicated and accessible Human Resources team.
WuXi AppTec 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.
Responsible for providing direct support and 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 formation
o Build a technical and scientific team focused on supporting and improving operational performance in aspects of process and human performance
o Develops team technically, to investigate using various tools, with verbal and written communication and with lean and six sigma methodology
o 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 reports
o Conducts employee performance appraisals in a timely and objective manner
Quality Systems
o Reviews quality systems to ensure compliance, robustness and to identify areas of opportunity for coaching and improvement
o Participates, coaches and may lead complex quality system performance
o 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 support
o 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 contracts
o Provides leadership to a team that leads complex technical investigations, CAPA/action plans and change controls
o 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 transfer
o 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 Manufacturing
o 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
New hires must be fully vaccinated against COVID-19 and provide proof of vaccination or receive an approved medical or religious exemption from Human Resources. This offer is contingent upon WuXi ATU verifying your vaccination status or approving an exemption request prior to your start date. If you wish to be considered for a medical or religious exemption, request an exemption by notifying WuXi as soon as possible, but no later than one week before your start date.
Our Values:
Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.
Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a
dedicated and accessible Human Resources team.
WuXi AppTec 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.