Manufacturing Associate I – 1st Shift – 12hrs.
Philadelphia, PA, United States
Job Description
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 benefits include:
The Manufacturing Associate I is responsible for 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 concepts
• Able to operate and maintain equipment
• Performs solution and material preparation
• Possesses basic technical knowledge and background
• Participates on and performs technical transfer activities
• Assists with the execution of validation activities
• Receives and organizes materials
• Identifies and communicates material discrepancies
• Uses some support systems (e.g. LIMS)
• Understands the concept of manufacturing processes and methods
• Collects and records scientific and process data per good document practices
• Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs)
• Follows and executes Standard Operating Procedures (SOPs)
• Follows and executes Batch Records (BRs)
• Participates in the development of technical documents such as non-conforming events and deviations
• Possess basic computer skills and able to efficiently use basic Microsoft applications
• Suggests continuous improvement ideas
• Identifies technical problems
• Participates on regulatory inspections and client audits
• Interacts on a minimal basis with groups that support manufacturing
• Cross trains in other areas and may be utilized to perform above job functions across the entire site
• Performs well under direct supervision
Qualifications
• High School diploma and over 2 years of relevant experience
OR
• Associates'/Bachelor's (science preferred) degree with 0-2 years of relevant or equivalent experience
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 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 skills
• Need to be able to read, write and understand English
• Proficient in Microsoft (Excel, Word, Outlook)
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, disability, veteran status, or any other characteristic protected by state, federal, or local law.
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 benefits include:
- 401K matching
- PTO
- Employee discount programs
- Medical, dental and vision insurance
- and much more
The Manufacturing Associate I is responsible for 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 concepts
• Able to operate and maintain equipment
• Performs solution and material preparation
• Possesses basic technical knowledge and background
• Participates on and performs technical transfer activities
• Assists with the execution of validation activities
• Receives and organizes materials
• Identifies and communicates material discrepancies
• Uses some support systems (e.g. LIMS)
• Understands the concept of manufacturing processes and methods
• Collects and records scientific and process data per good document practices
• Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs)
• Follows and executes Standard Operating Procedures (SOPs)
• Follows and executes Batch Records (BRs)
• Participates in the development of technical documents such as non-conforming events and deviations
• Possess basic computer skills and able to efficiently use basic Microsoft applications
• Suggests continuous improvement ideas
• Identifies technical problems
• Participates on regulatory inspections and client audits
• Interacts on a minimal basis with groups that support manufacturing
• Cross trains in other areas and may be utilized to perform above job functions across the entire site
• Performs well under direct supervision
Qualifications
• High School diploma and over 2 years of relevant experience
OR
• Associates'/Bachelor's (science preferred) degree with 0-2 years of relevant or equivalent experience
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 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 skills
• Need to be able to read, write and understand English
• Proficient in Microsoft (Excel, Word, Outlook)
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, disability, veteran status, or any other characteristic protected by state, federal, or local law.
Apply
Career Focus: Manufacturing
Similar Jobs
Quality Assurance & Compliance Associate
Sobi offers the opportunity to work at an international pharmaceutical c...
Quality Assurance Architect (30928-1)
Seeking a dedicated Quality Assurance Architect to join our team in Bern...
Technical Operations Specialist II
Overview Job Summary: Responsible for generating and/or review manufactu...
Technical Operations Specialist II
Overview Job Summary: Responsible for generating and/or review manufactu...