Production/Quality Supervisor

2 weeks ago

Philadelphia, United States WuXi AppTec Full time
WuXi 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).

Understands, oversees, trains, coaches, mentors and manages performance of

others on basic aseptic operational techniques as well as, performing solution,

material preparation, analyzing results and facility start-up engineering and

mechanical knowledge. Understands, teaches and coaches others on all operations, functions, capability

of equipment and ancillary support to equipment and is able to perform complex

troubleshooting Drives sourcing and purchasing of standard, new and complex equipment Reviews and approves solution and material preparation results and resolves

issues Reviews protocols and other technical transfer documents Identifies and drives application of GMP concepts and is able to recommend and

identify improvements as the process develops during phases of technical transfer Forecast and performs material procurement activities Acts a lead, member or Champion that helps to design the new system or of a

systems improvement team Understands the concept of and has performed or experience with manufacturing

processes and methods Trains, coaches mentors and manages performance of others on basic operations

such as media preparation, thaw, passage and harvesting and specific unit

operations and overall systems across assigned programs, in the manufacturing

process Interprets data and draws conclusions Collects, records, reviews, performs analysis, interprets, identifies trends of

scientific and process data per good document practices Communicates with internal and external stakeholders scientific and process data

and recommends path for forward processing Follows compliance and regulatory requirements and current Good Manufacturing

Practices (cGMPs) and understands ‘why’ behind the regulations Identifies, communicates, addresses and improves complex cGMP compliance

and 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-conforming

events and deviations Accountable for schedule preparation, forecasting, adjustments and performance

of work assignments for team to ensure adequate staffing across assigned and

site specific programs 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 Develops, coordinates, and follows organizational systems, policies, procedures,

and follows labor and capacity standards ~ BS/BA in Science related field preferred; Demonstrated Lean / Six Sigma knowledge, desired Thorough understanding of Good Laboratory Practices and Good Manufacturing

Practices 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. Need to be able to read, write and understand English Proficient in Microsoft (Excel, Word, Outlook)

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.

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