WuXi AppTec

Senior Manufacturing Associate

Job Locations US-PA-Philadelphia
Job ID
2017-3366

Overview

Independent associate responsible for manufacture of Cell & Gene Therapy products, Master and Working Cell Banks, and final product fills following cGMPs.

Responsibilities

  • Performs the manufacturing process for the production of Cell & Gene Therapy products, Master and Working Cell Banks, and final product fills.
  • Adheres to Good Manufacturing Practices and standard operating procedures.
  • Demonstrates innovative technical knowledge and significantly contributes to the overall production efficiency.
  • Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation.
  • Contributes to the achievement of company and departmental goals and objectives.
  • Has a working knowledge of the regulatory compliance requirements for the production of commercially manufactured biologics.
  • Remains current regarding current Good Manufacturing Practices (cGMP) guidelines and develops and/or modifies production methods to fully address compliance issues.
  • Often functions as the lead operator in manufacturing operations in assigned area per cGMPs.
  • Analyzes scientific data with accuracy and precision, critical at time of processing. 
  • Authors Batch Production Records, complex Standard Operating Procedures (SOP’s), Product Specification Sheets, and Solution Preparation Records as needed to accurately reflect manufacturing processes.
  • Completes production records and maintains clean room environment to comply with regulatory requirements.
  • Reviews Equipment/Suite logbooks
  • Provides leadership in the startup and validation efforts for the Manufacturing Facility and may represent Manufacturing during Factory Acceptance Testing of new equipment.
  • Ensures junior manufacturing personnel comply with Standard Operating Procedures (SOP’s) and Batch Records and that training records for junior staff are accurate and current.
  • Possesses sound scientific knowledge and understanding of manufacturing processes and uses this skill set to routinely monitor manufacturing processes and recognize potential process issues as they arise.
  • In conjunction with management personnel, participates in the technical transfer, planning, implementation, and maintenance of manufacturing processes and procedures.
  • Authors Adverse Events and Reviews Validation reports and Master Production Records to ensure documents are accurate and complete.
  • Works on routine manufacturing assignments as well as assignments that are very complex in nature where independent action and a high degree of initiative are required in resolving problems and making recommendations.
  • Works with senior manufacturing personnel to improve and optimize manufacturing methods.
  • Evaluates operating procedures for accuracy and efficient operation and makes corrections as necessary.  
  • Expert on all aspects of assigned processes.
  • Provides training and operational guidance to junior staff and also serves to mentor junior staff in manufacturing techniques.
  • May provide feedback to area management on junior staff performance.
  • Provides technical expertise to area associates and supervision during process and equipment troubleshooting exercises.
  • Provides operational support for (Specific Dept.) activities including (Ex. media/buffer preparation, cleaning activities, and equipment/materials staging/ Aseptic Technique).
  • Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
  • Normally receives minimal instructions on routine work and detailed instructions on new assignments.
  • Works under close supervision from supervisor or senior personnel.
  • Performs support functions (e.g. Runner function) in the (fill in Specific Dept.)
  • Ability to work in a team environment and independently as required
  • Maybe required to work Holidays and weekends
  • Maybe required to work Overtime ( Remove only for Exempt positions) 
  • 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

Qualifications

Experience / Education   

  • 4 years of relevant experience or equivalent
  • Bachelors’ degree or equivalent experience
  • Preferred (Ex. AALAC certifications, SPHR)

 

Knowledge / Skills / Abilities:

  • Significant experience in aseptic processing techniques and a thorough understanding of regulatory requirements for a cGMP manufacturing facility is required.
  • Ability to work under limited supervision and to handle problems of a more difficult nature.
  • 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).
  • 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 Area Management.
  • Proficient in Oral & Written communication skills
  • Need to be able to read, write and understand English (Mandarin)
  • Proficient in Microsoft (Excel, Word, Outlook)

 

Physical Requirements:

  • Must be able to work in an office environment with minimal noise conditions.
  • Must be able to work in Lab setting with exposure to Animals/biohazards / Chemicals (List specific Chemicals)
  • Must be able to wear appropriate PPE
  • Must be able to work in environment with variable noise levels
  • Ability to stand /Sit/walk for long periods of time
  • Ability to Lift X lbs routinely
  • Ability to crouch, bend, twist, and reach
  • Ability to push/pull X 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

Equal Opportunity Employer Minorities/Women/Veterans/Disabled 

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