OverviewWuXi Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the development and availability of life-saving therapies for patients in need.Responsible for providing direct oversight and leadership in the manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).Work schedule: Wed – Sat: 12:00pm – 12:30amResponsibilities
Understands, oversees, trains, coaches, mentors and manages performance ofothers on basic aseptic operational techniques as well as, performing solution,material preparation, analyzing results and facility start-up engineering andmechanical knowledge.
Understands, teaches and coaches others on all operations, functions, capabilityof equipment and ancillary support to equipment and is able to perform complextroubleshooting
Drives sourcing and purchasing of standard, new and complex equipment
Reviews and approves solution and material preparation results and resolvesissues
Reviews protocols and other technical transfer documents
Identifies and drives application of GMP concepts and is able to recommend andidentify improvements as the process develops during phases of technical transfer
Executes in-house and offsite validation activities
Forecast and performs material procurement activities
Uses all support systems (e.g. LIMS) with demonstrated proficiency and able toact as an subject matter expert (SME) and/or Super user on a system
Acts a lead, member or Champion that helps to design the new system or of asystems improvement team
Understands the concept of and has performed or experience with manufacturingprocesses and methods
Trains, coaches mentors and manages performance of others on basic operationssuch as media preparation, thaw, passage and harvesting and specific unitoperations and overall systems across assigned programs, in the manufacturingprocess
Interprets data and draws conclusions
Identifies process and method gaps and opportunities and implementsimprovements across assigned programs and site specific
Collects, records, reviews, performs analysis, interprets, identifies trends ofscientific and process data per good document practices
Communicates with internal and external stakeholders scientific and process dataand recommends path for forward processing
Follows compliance and regulatory requirements and current Good ManufacturingPractices (cGMPs) and understands ‘why’ behind the regulations
Identifies, communicates, addresses and improves complex cGMP complianceand regulatory gaps and issues across assigned programs and site specific
Responsible for ensuring employees are trained on Batch record, SOPs,equipment, all unit operations and non-manufacturing SOPs and systems
Authors, reviews and approves technical documents such as non-conformingevents and deviations
Identifies, suggests, participates, leads, implements and champions continuousimprovement ideas
Accountable for schedule preparation, forecasting, adjustments and performanceof work assignments for team to ensure adequate staffing across assigned andsite specific programs
Regularly interacts with and supports cross-functional teams.
Accomplishes staff results by communicating updated organizationalinformation, job expectations & supporting their work
Plans, monitors, and appraises direct reports including performancecompetencies, goals & job results
Coaches, counsels, and conducts disciplinary actions
Develops, coordinates, and follows organizational systems, policies, procedures,and follows labor and capacity standards
Qualifications
HS Diploma or equivalent required and
5+ years relevant technical experience and min 2 years in aLead/Leadership/Supervisory Role
BS/BA in Science related field preferred; or combination of relevant Experience &Education
Knowledge / Skills / Abilities:
Demonstrated Lean / Six Sigma knowledge, desired
Ability to accurately and reproducibly perform arithmetic calculations includingfractions, decimals and percentages and basic algebraic and geometriccalculations.
Thorough understanding of Good Laboratory Practices and Good ManufacturingPractices
Has basic financial knowledge and acumen
Possesses basic and fundamental engineering and mechanical knowledge and isable to apply in the manufacturing area demonstrating unit operational and endto-end understanding
Possesses technical knowledge and background in the pharmaceutical and biotechnology industry, specifically in cell and gene therapy.
Proficient in Oral & Written communication skills
Need to be able to read, write and understand English
Proficient in Microsoft (Excel, Word, Outlook)
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.Need help finding the right job?We can recommend jobs specifically for you!
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disabilityAn Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability (https://careers-wuxiapptec.icims.com/connect?back=intro&findajob=1&iniframe=1&hashed=-435740542)Job Locations US-PA-Philadelphia