Technical Operations Specialist I

About the position

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.

Responsibilities

• Generates and/or reviews manufacturing related technical documents.
• Manages timely closure of technical documents including Non-Conforming Event (NCE) investigations, CAPAs, Change Controls (CC), Batch Records (BR), Technical Transfers (TT), Final Reports (FR), and Standard Operating Procedures (SOP).
• Understands aseptic technique concepts.
• Identifies unacceptable practices and implements improvements.
• Understands basic operations and functions of equipment.
• Works with vendor and clients to understand and resolve issues.
• Understands basic solution and material preparation.
• Possesses 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.
• Possesses basic and fundamental facility start-up experience.
• Possesses basic and fundamental understanding of technical transfer activities.
• Understands the application of GMP concepts and recommends improvements.
• Possesses basic and fundamental understanding of validation activities and execution.
• Possesses basic and fundamental understanding of material related activities and execution.
• Proficient on Master Control.
• Possesses some proficiency on NovaTek and support systems (e.g. LIMS).
• Understands the concept and working application of manufacturing processes and methods.
• Possesses manufacturing unit operational expertise.
• Identifies, participates, and explains acceptable and unacceptable practices.
• Performs basic and complex analysis, interprets, and draws conclusions of scientific and process data.
• Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs).
• Identifies, communicates, addresses and improves cGMP compliance and regulatory gaps.
• 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.
• Trains others on SOPs, equipment and unit operations.
• Mentors others on Technical Operations SOPs and systems.
• Participates in the development of and authors technical documents.
• Possesses basic computer skills and efficiently uses basic Microsoft applications.
• Suggests, participates, implements and leads continuous improvement ideas.
• Identifies, participates, suggests solutions and leads technical problems.
• Participates, supports, presents and represents as an SME during regulatory inspections and client audits.
• Interacts frequently with support groups and coordinates with groups.
• Cross trains in other areas and may perform job functions across the entire site.
• Performs well under minimal supervision and starts to work independently on complex tasks.
• Possesses lean/six sigma knowledge and experience.
• May be required to work Holidays and weekends.
• May be required to work Overtime and outside of normal business hours.
• Contributes to the overall operations and to the achievement of departmental goals.
• Performs 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.

Requirements

• High School diploma and over 2 years of relevant experience or Associates'/Bachelor's (science preferred) degree with 1 year of relevant or equivalent experience.
• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages.
• Clarity of vision at near and mid-ranges, depth perception and ability to identify and distinguish colors.
• Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE).
• Works in production environment with exposure to latex and bleach.
• Proficient in Oral & Written communication skills.
• Need to be able to read, write and understand English.
• Proficient in Microsoft (Excel, Word, Outlook).

Nice-to-haves

• Possesses lean/six sigma knowledge and experience.
• Ideally, possesses basic and fundamental facility start-up experience.

Benefits

• 401K matching
• PTO
• Employee discount programs
• Medical, dental and vision insurance
• and much more