Overview

　　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.

　　Working at WuXi Advanced Therapies means being part of a dynamic, fast-paced, and innovative environment where you will have the opportunity to work on cutting-edge technology and make a real difference in the lives of patients. Our culture is collaborative and supportive, with a focus on teamwork and continuous learning.

　　Our parent company, WuXi AppTec has over 1,800 US-Based employees located with 11 facilities in 8 states. Globally WuXi AppTec spans to more than 39,000 employees with 32 facilities in 9 countries.

　　Our benefits include:

　　401K matching

　　PTO

　　Employee discount programs

　　Medical, dental and vision insurance

　　and much more.

　　The Manufacturing Manager is responsible for providing direct oversight and leadership in themanufacture of Master and Working Cell Banks and performing activities withinproduction facilities to support manufacture of Cell & Gene Therapy products, andfinal product fills according to current Good Manufacturing Practices (cGMPs). This role will be night shifts.

　　Responsibilities

　　Jobs Essential Functions:

　　Understands aseptic technique concepts

　　Oversees and monitors overall performance of aseptic technique ensuringcompliance with standards

　　Has performed aseptic technique, is able to identify unacceptable practices andmake spot corrections to performance

　　Understands and is able to explain ‘why’ of acceptable and unacceptable aseptic technique practice

　　Trains, coaches, mentors front line management and manages performance of others on basic aseptic operational techniques such as media preparation, thaw, passage and harvesting and overall systems and operations

　　Identifies aseptic technique gaps and opportunities and implements improvements across site specific programs

　　Able to operate and maintain equipment

　　Understands, determines and manages maintenance requirements (preventative and calibration) of equipment and works with vendor to resolve issues

　　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

　　First line decision maker for equipment issues

　　Trains, coaches, mentors front line management and manages performance of others performing solution and material preparation, analyzing results and resolving issues

　　Reviews and approves solution and material preparation results and resolves issues

　　First line decision maker for solution and material preparation issues

　　Possesses technical knowledge and background in the pharmaceutical and biotechnology industry, specifically in cell and gene therapy

　　Trains, coaches and mentors others in technical knowledge and background in the pharmaceutical and biotechnology industry, specifically in cell and gene therapy

　　Possesses basic and fundamental engineering and mechanical knowledge and is able to apply in the manufacturing area demonstrating unit operational and endto-end understanding

　　Trains, coaches, and mentors others with engineering and mechanical knowledge and how to apply to manufacturing area for unit operations and end-to-end understanding

　　Possesses basic and fundamental facility start-up experience

　　Trains, coaches, mentors others on facility start-up

　　Has participated in facility start-ups and may lead a subteam that requires leading, planning, coordinate, delegate and manage across site specific programs

　　Provides input into facility design and works with team to make decisions on design

　　Participates on and performs technical transfer activities

　　Trains, coaches, mentors and manages performance of technical transfer activities

　　Provides feedback for facility fit

　　Reviews and approves 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 across the site during phases of technical transfer

　　Executes in-house and offsite validation activities

　　Trains, coaches, mentors and manages performance of validation activities

　　Provides input, reviews and approves validation documents

　　Has working knowledge of validation requirement

　　Identifies validation gaps and needs across site specific programs

　　Trains, coaches and manages performance of scheduling, receipt andorganization of materials

　　Forecast and performs material procurement activities

　　Reviews and finalizes material documents

　　Approves CS forms

　　Approves change controls for new material implementation

　　Identifies, communicates and resolves material discrepancies

　　Possess awareness for all support systems (e.g. LIMS)

　　Trains, coaches, mentors and manages performance of others use of support systems

　　Acts a lead, member, Champion or Sponsor 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 front line management and manages performance of manufacturing processes and methods ensuring compliance with standards

　　Trains, coaches, mentors front line management and manages performance ofothers on basic operations such as media preparation, thaw, passage and harvesting and specific unit operations and overall systems across site specific programs

　　Interprets data and draws conclusions

　　Identifies, understands, trains, coaches, mentors front line management, managesperformance and able to explain the ‘why’ of acceptable and unacceptable practices, is able to make on the spot corrections to performance

　　Identifies process and method gaps and opportunities and implementsimprovements across site

　　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. Able to train, coach, mentor, mentors front line management and manage performance of others to do the same

　　Identifies, communicates, addresses and improves complex cGMP compliance and regulatory gaps and issues across site

　　Follows and executes Standard Operating Procedures (SOPs)

　　Trains, coaches, mentors front line management and manages performance of others who execute SOPs

　　Revises, authors and reviews simple and complex SOPs

　　Standardizes and aligns SOPs

　　Improves the efficiency and execution of SOPs

　　Reviews and approves SOPs

　　Trains, coaches, mentors front line management and manages performance of others who execute BRs

　　Improves the efficiency and right-first-time (RFT) of BR execution

　　Standardizes and aligns BRs

　　Reviews and approves BRs

　　Accountable for ensuring front line management ensure associates are trained on SOPs, equipment, all unit operations and non-manufacturing SOPs and systems

　　Communicates training needs

　　Makes suggestions to the training program

　　Authors, reviews and approves technical documents such as non-conforming events and deviations

　　Teaches, coaches, mentors front line management and manages performance of others participating, providing information and authoring technical documents

　　Possess basic computer skills and able to efficiently use basic Microsoft applications

　　Suggests, participates, leads, implements and sponsors continuous improvement ideas

　　Teaches, coaches and mentors front line management of others to identify, suggest, participate and lead continuous improvement ideas

　　Identifies, participates, suggests solutions and leads complex technical problem solving

　　Teaches, coaches and mentors others to solve technical problems

　　First line decision maker for technical problems

　　Identifies, suggests with options, recommends path forward and leads complex decision making sessions

　　Teaches, coaches and mentors front line management on how to make decisions

　　First line decision maker for issues that require decisions

　　Delegates work assignments

　　Accountable for schedule preparation, forecasting, adjustments and performance of work assignments for team to ensure adequate staffing across site specific programs and site

　　Teaches, coaches and mentors front line management to delegate, prepare the schedule and how to make adjustments to assign and perform work

　　Participates, supports, assists as an SME, leads, resolves conflict, presents and represents during regulatory inspections and client audits

　　Regularly interacts with groups that support manufacturing

　　Identifies and works to resolve issues and relations with groups that support manufacturing

　　Coordinates, deals with problems and is the first line manufacturing decision maker with groups that support manufacturing in a cross functional manner

　　Cross trains in other areas and may be utilized to perform above job functions across the entire site

　　Has basic financial knowledge and acumen

　　Delivers performance efficiencies to impact assigned program and site specific programs, department and site gross margin

　　Performs well under direct supervision and works independently on complex tasks and processes

　　Manages the manufacturing process, projects and people

　　Train, coaches and mentors front line management on how to lead and oversee manufacturing processes

　　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 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

　　Education

　　HS Diploma or equivalent required and

　　5+ years relevant technical experience and min 2 years Managing people

　　BS/BA in Science related field preferred; or combination of relevant Experience &Education

　　Knowledge / Skills / Abilities:

　　Ability to accurately and reproducibly perform arithmetic calculations includingfractions, decimals and percentages and basic algebraic and geometriccalculations.

　　Clarity of vision at near and mid-ranges (less than 20 feet), depth perception andability to identify and distinguish colors.

　　Must be able to wear appropriate clean room attire (i.e. surgical masks) and allPersonal Protective Equipment (PPE).

　　Works in production environment with exposure to latex and bleach. Potentialexposure to noise and equipment hazards (i.e. vacuum pumps, pressurizedvessels), dangerous materials (i.e. chemicals, solvents, pathogens), freezer burns,allergens and strong odors.

　　Based on work assignment, may be recommended to have medical testing inaccordance with the company’s Occupational Health Program.

　　Holiday and shift work often required based on manufacturing schedule asdetermined by Management.

　　Proficient in Oral & Written communication skills

　　Need to be able to read, write and understand English

　　Proficient in Microsoft (Excel, Word, Outlook)

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　　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&in_iframe=1&hashed=-435740542)

　　Job Locations US-PA-Philadelphia

　　Job ID 2024-12524