Welcome page Returning Candidate? Log back in! Senior Supervisor Technical Operations Job Locations US-PA-Philadelphia Job ID 2024-13173 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. 

 

As the Senior Supervisor Technical Operations, you will be Responsible for providing technical support to 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).

Responsibilities Understands aseptic technique conceptsMonitors overall performance of aseptic technique ensuring compliance with standardsIdentifies aseptic technique gaps and opportunities and implements improvements across assigned programsUnderstands basic operations and functions of equipment Understands the corrective/preventative maintenance and calibration of equipmentWorks with vendor to understand and resolve issuesUnderstands basic solution and material preparationTrains, coaches, mentors and manages performance of others performing solution and material preparation, analyzing results and resolving issuesPossesses technical knowledge and background in the pharmaceutical and biotechnology industry, specifically in cell and gene therapyTrains, coaches and mentors others in technical knowledge and background in the pharmaceutical and biotechnology industry, specifically in cell and gene therapyPossesses basic and fundamental engineering and mechanical knowledge and is able to apply in the manufacturing area demonstrating unit operational and end-to-end understandingTrains, coaches, and mentors others with engineering and mechanical knowledge and how to apply to manufacturing area for unit operations and end-to-end understandingIdeally, possesses basic and fundamental facility start-up experienceIdeally, trains, coaches, mentors others on facility start-upIdeally, has participated in facility start-ups and may lead a subteam that requires leading, planning, coordinate, delegate and manage across assigned programsIdeally, provides input into facility designTrains, coaches, mentors and manages performance of technical transfer activitiesReviews protocols and provides input on other technical transfer documentsUnderstands the application of GMP concepts as the process develops during phases of technical transferTrains, coaches, mentors and manages performance of validation activitiesProvides input and review validation documentsHas working knowledge of validation requirementsIdentifies validation gaps and needs across assigned programsPossesses basic and fundamental understanding of material related activities and executionSubject Matter Expert (SME) on Master ControlInternal SME on some support systems (e.g. LIMS)Trains, coaches, mentors and manages performance of others use of support systemsActs as 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 methodsTrains, coaches, mentors and manages overall performance of manufacturing processes and methods ensuring compliance with standardsPossesses manufacturing end-to-end operational expertiseIdentifies, participates, understands and able to explain the ‘why’ of acceptable and unacceptable practices; is able to make suggestions with options and recommend path forward and leads basic sessions to improve performance Understands processes and recommends product/lot impactIdentifies process and method gaps and opportunities and implements improvements across assigned programs and site specific and teaches, coaches, mentors and manages performance of others to do the samePerforms basic and complex analysis, interprets, and draws conclusion of scientific and process data per good document practicesCommunicates with internal and external stakeholders scientific and process data and recommends path for forward processingFollows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) and understands ‘why’ behind the regulations.  Able to train, coach, mentor and manage performance of others to do the sameIdentifies, communicates, addresses and improves complex cGMP compliance and regulatory gaps and issues across assigned programs and site specificFollows and executes Standard Operating Procedures (SOPs)Trains, coaches, mentors and manages performance of others who execute SOPsRevises, authors and reviews simple and complex SOPsStandardizes and aligns SOPsImproves the efficiency and execution of SOPsReviews and approves SOPs Qualifications

Qualifications

HS Diploma or equivalent required and 7+ years relevant technical experience and min 3 years in a Lead/Leadership/Supervisory Role BS/BA in Science related field preferred; or combination of relevant Experience & Education

Knowledge / Skills / Abilities:

Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.Clarity of vision at near and mid-ranges (less than 20 feet), depth perception and ability to identify and distinguish colors.Must be able to work in Lab setting with  Biohazards /various ChemicalsMust be able to wear appropriate clean room attire (i.e. surgical masks) and all Personal Protective Equipment (PPE).Works in production environment with exposure to latex and bleach.  Potential exposure to noise and equipment hazards (i.e. vacuum pumps, pressurized vessels), dangerous materials (i.e. chemicals, solvents, pathogens), freezer burns, allergens and strong odors.  Based on work assignment, may be recommended to have medical testing in accordance with the company’s Occupational Health Program.  Holiday and shift work often required based on manufacturing schedule as determined by Management.Proficient in Oral & Written communication skillsNeed to be able to read, write and understand English (Mandarin) Proficient in Microsoft (Excel, Word, Outlook)

 

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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 disability
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