Technical Operations Specialist III
Philadelphia, PA, United States
Posted on: December 1, 2023
Closing: December 01, 2024
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
- Employee discount programs
- Medical, dental and vision insurance
- and much more
The Technical Operations Specialist III 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).
- 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
- Possesses basic and fundamental understanding of technical transfer activities
- 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
- Participates, provides information in the development of, authors, reviews and is able to coach, teach and mentor others with technical documents such as nonconforming events, deviations, CAPA's, action plans and change controls
- 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
- 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 Overtime
- May be required to work outside of normal business hour
- Other duties as assigned
- May be required to assist in other departments
Experience / Education:
- High School diploma and over 8 years of relevant experience or
- Associates'/Bachelor's (science preferred) degree with over 4 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
- Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
- Based on work assignment, may be recommended to have medical testing in accordance with the company's Occupational Health Program.
- Proficient in Oral & Written communication skills
- Need to be able to read, write and understand English
- Proficient in Microsoft (Excel, Word, Outlook)
- Must be able to work in an office environment with minimal noise conditions.
- Must be able to work in Lab setting with Biohazards /various 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 40 lbs routinely
- Ability to crouch, bend, twist, and reach
- Ability to push/pull 40 lbs routinely/ often / occasionally
- 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 perform activities with repetitive motions
- Ability to climb Ladders / Stairs / Scaffolding
- Ability to work in variable temperatures high to freezing
- Inside/outside working conditions
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
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.
Posted on: December 1, 2023
Closing: December 01, 2024