Responsible for coordinating the training for those who produce Master and Working Cell Banks and activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs)
Responsibilities
• Coordinates, scheduled, plans and supports such that PM/calibration requirements are met
• Possesses basic industry knowledge, ideally background in the pharmaceutical and biotechnology industry or cell and gene therapy
• Performs, trains, mentor and manage trainees on performance of material related activities
• Schedules, forecasts receives and organizes materials
• Identifies and communicates material discrepancies
• Performs material procurement activities
• Creates, revises, reviews and finalizes material documents
• First point of escalation for material related issues
• Uses and trains others on the use of support systems (e.g. LIMS) with some proficiency
• Understands the concept of manufacturing processes and methods
• Collects and coordinates 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 cGMP compliance and regulatory gaps and issues
• Tracks the review and approval of Batch Record (BR) deliverables
• Trains, coaches and mentors trainees on basic and manufacturing specific introductory items
• Initiates preliminary access for trainees
• Compiles and presents training metrics
• Performs, trains, coaches and mentors others to maintain record files and databases
• Possess basic computer skills and able to efficiently use basic Microsoft applications
• Uses, proficient, an SME and may lead the implementation or improvement with an automated training documentation system
• Suggests, participates and implements continuous improvement ideas
• Identifies, participates, suggests with options, recommends path forward and leads basic decision making sessions
• Prepares, forecasts, communicates, makes adjustments training schedule, assignments, tasks and needs
• Makes suggestions to the training program
• Participates, supports, presents and represents as an SME during regulatory inspections and client audits
• Regularly interacts with groups that support manufacturing
• Identifies and works to resolve issues and relations with groups that support manufacturing
• Coordinates and deals with problems with groups that support manufacturing in a cross functional manner
• Performs well under direct supervision and works autonomously on training tasks and processes
• Able to identify and prioritize escalations
• Evaluates trainees and provides feedback
• Cross trains in other areas and may be utilized to perform above job functions across the entire site
• May be required to work Holidays and weekends
• May be required to work Overtime
Qualifications
• High School diploma and over 3 years of relevant experience or
• Associates’/Bachelor’s (ideally science) degree with over 1 year 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 E
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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