Job Information
WuXi AppTec Senior Manufacturing Science & Technology Associate in Philadelphia, Pennsylvania
Overview
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
Authors documentation which include but not limited toinvestigations/deviations/non-conforming events, action plans, CAPAs, changecontrols and protocols
Provides and leads complex technical support and troubleshooting of routinemanufacturing, issue resolution, improvement, optimization and life cycle management
Supports, performs and leads process technology transfer
Performs and leads process monitoring, trending, comparability and controls
Supports, performs and leads late stage studies, validation, characterization and robustness, production and regulatory filings in support of commercialization efforts
Understands aseptic technique concepts
Able to identify unacceptable practices and implement improvements
Understands basic operations and functions of equipment
Understands the corrective/preventative maintenance and calibration of equipment
Works with vendor to understand and resolve issues
Understands basic solution and material preparation
Possesses basic technical knowledge and background in the pharmaceutical and biotechnology industry and in cell and gene therapy
Possesses basic/fundamental and working application of engineering and mechanical knowledge and is able to apply end-to-end in the manufacturing area
Ideally, possesses basic and fundamental facility start-up experience
Understands the application of GMP concepts and is able to recommend and identify improvements as the process develops during phases of technical transfer
Possesses basic and fundamental understanding of validation activities and execution
Possesses basic and fundamental understanding of material related activities and execution
Subject Matter Expert (SME) on Master Control
Possesses some proficiency on NovaTek
Possesses some proficiency of support systems (e.g. LIMS)
Understands the concept and working application of manufacturing processes and methods
Possesses manufacturing end-to-end operational expertise
Identifies, 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
Performs basic and complex analysis, interprets, and draws conclusion of scientific and process data per good document practices
Follows compliance and regulatory requirements and current Good Manufacturing
Practices (cGMPs) and understands ‘why’ behind the regulations.
Identifies, communicates, addresses and improves simple and complex cGMP compliance and regulatory gaps and issues
Follows and executes Standard Operating Procedures (SOPs)
Revises, authors and provides comments as a reviewer to simple SOPs
Improves the efficiency and execution of SOPs
Improves the efficiency and right-first-time (RFT) of BR execution
Trains others on SOPs, equipment and unit operations
Trains others on Technical Operations SOPs and systems
Possess basic computer skills and able to efficiently use basic Microsoft applications
Suggests, participates, implements and leads continuous improvement ideas
Identifies, participates, suggests solutions and leads basic and complex technical problems
Identifies, participates, suggests with options, recommends path forward and leads basic and complex decision making
Prepares work assignment schedules
Starts to delegate work assignments
Participates, supports, presents and represents as an SME during regulatory inspections and client audits
Interacts frequently with groups
Regularly coordinates and deals with problems with groups
Cross trains in other areas and may be utilized to perform above job functions across the entire site
Works independently on complex tasks and processes
Possesses lean/six sigma knowledge and experience
May be required to work Holidays and weekends
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.
Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
Other duties as assigned
May be required to assist in other departments
Qualifications
5+ years relevant technical experience and min 2 years in a Lead/Leadership/Supervisory Role
BS/BA in Science related field preferred; or combination of relevant Experience & Education
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 wear appropriate clean room attire (i.e. surgical masks) and all Personal Protective Equipment (PPE).
Must be able to work in Lab setting with Biohazards /various Chemicals
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 skills
Need to be able to read, write and understand English
Proficient in Microsoft (Excel, Word, Outlook)
Ability to stand /Sit/walk for long periods of time
Ability to Lift 40 lbs routinely
Ability to crouch, bend, twist, and reach
Ability to push/pull 40 lbs routinely/ often / occasionally
Clarity of Vision
Ability to identify and distinguish colors
Must be able to perform activities with repetitive motions
Ability to climb Ladders / Stairs / Scaffolding
Ability to work in variable temperatures high to freezing
Inside/outside working conditions
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
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Job Locations US-PA-Philadelphia
Job ID 2024-13012
WuXi AppTec
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