Senior Manufacturing Science & Technology Associate

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

• 401K matching

• PTO

• Employee discount programs

• Medical, dental and vision insurance

• and much more.

Manufacturing Science & Technology Associate II is 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

Responsibilities

• Authors documentation which include but not limited to investigations/deviations/non-conforming

events, action plans, CAPAs, change controls and protocols

• Provides technical support and troubleshooting of routine manufacturing, issue resolution,

improvement, optimization and life cycle management

• Supports and performs process technology transfer

• Performs process monitoring, trending, comparability and controls

• Supports and performs 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 maintenance 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, ideally in cell and gene therapy

• Possesses basic/fundamental and working application of engineering and mechanical knowledge

and is able to apply in the manufacturing area

• Ideally, possesses basic and fundamental facility start-up experience

• Possesses basic and fundamental understanding of validation activities and execution

• Possesses basic and fundamental understanding of material related activities and execution

• Proficient on Master ControlPossesses 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 unit operational expertise

• Identifies, participates, understands and able to explain the 'why' of acceptable

and unacceptable practices, is able to make suggestions 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

• Participates, supports, presents and represents as an SME during regulatory inspections and

client audits

• Interacts frequently with groups

• Regularly coordinates with groups

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

site

• Performs well under minimal supervision and starts to work 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

Qualifications

Qualifications

• HS Diploma or equivalent required, BS/BA in Science related field preferred; or a combination of

relevant Experience & Education

• 3+ years relevant technical experience and min 1 years in a Lead/Leadership/Supervisory Role

• 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

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).

• 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.

New hires must be fully vaccinated against COVID-19 and provide proof of vaccination or receive an approved medical or religious exemption from Human Resources. This offer is contingent upon WuXi ATU verifying your vaccination status or approving an exemption request prior to your start date. If you wish to be considered for a medical or religious exemption, request an exemption by notifying WuXi as soon as possible, but no later than one week before your start date.

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.

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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 (~~~)

Job Locations US-PA-Philadelphia

Job ID 2023-12470