Job Information
WuXi AppTec Manager Manufacturing in Philadelphia, Pennsylvania
Overview
Responsible for providing direct oversight and leadership in 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
Understands aseptic technique concepts
Oversees and monitors overall performance of aseptic technique ensuring compliance with standards
Has performed aseptic technique, is able to identify unacceptable practices and make spot corrections to performance
Understands and is able to explain ‘why’ of acceptable and unacceptable aseptic technique practice
Trains, coaches, mentors front line management and manages performance of others on basic aseptic operational techniques such as media preparation, thaw, passage and harvesting and overall systems and operations
Identifies aseptic technique gaps and opportunities and implements improvements across site specific programs
Able to operate and maintain equipment
Understands, determines and manages maintenance requirements (preventative and calibration) of equipment and works with vendor to resolve issues
Understands, teaches and coaches others on all operations, functions, capability of equipment and ancillary support to equipment and is able to perform complex troubleshooting
Drives sourcing and purchasing of standard, new and complex equipment
First line decision maker for equipment issues
Trains, coaches, mentors front line management and manages performance of others performing solution and material preparation, analyzing results and resolving issues
Reviews and approves solution and material preparation results and resolves issues
First line decision maker for solution and material preparation issues
Possesses technical knowledge and background in the pharmaceutical and biotechnology industry, specifically in cell and gene therapy
Trains, coaches and mentors others in technical knowledge and background in the pharmaceutical and biotechnology industry, specifically in cell and gene therapy
Possesses basic and fundamental engineering and mechanical knowledge and is able to apply in the manufacturing area demonstrating unit operational and endto-end understanding
Trains, coaches, and mentors others with engineering and mechanical knowledge and how to apply to manufacturing area for unit operations and end-to-end understanding
Possesses basic and fundamental facility start-up experience
Trains, coaches, mentors others on facility start-up
Has participated in facility start-ups and may lead a subteam that requires leading, planning, coordinate, delegate and manage across site specific programs
Provides input into facility design and works with team to make decisions on design
Participates on and performs technical transfer activities
Trains, coaches, mentors and manages performance of technical transfer activities
Provides feedback for facility fit
Reviews and approves protocols and other technical transfer documents
Identifies and drives application of GMP concepts and is able to recommend and identify improvements as the process develops across the site during phases of technical transfer
Executes in-house and offsite validation activities
Trains, coaches, mentors and manages performance of validation activities
Provides input, reviews and approves validation documents
Has working knowledge of validation requirement
Identifies validation gaps and needs across site specific programs
Trains, coaches and manages performance of scheduling, receipt and organization of materials
Forecast and performs material procurement activities
Reviews and finalizes material documents
Approves CS forms
Approves change controls for new material implementation
Identifies, communicates and resolves material discrepancies
Possess awareness for all support systems (e.g. LIMS)
Trains, coaches, mentors and manages performance of others use of support systems
Acts a lead, member, Champion or Sponsor that helps to design the new system or of a systems improvement team
Understands the concept of and has performed or experience with manufacturing processes and methods
Trains, coaches, mentors front line management and manages performance of manufacturing processes and methods ensuring compliance with standards
Trains, coaches, mentors front line management and manages performance of others on basic operations such as media preparation, thaw, passage and harvesting and specific unit operations and overall systems across site specific programs
Interprets data and draws conclusions
Identifies, understands, trains, coaches, mentors front line management, manages performance and able to explain the ‘why’ of acceptable and unacceptable practices, is able to make on the spot corrections to performance
Identifies process and method gaps and opportunities and implements improvements across site
Collects, records, reviews, performs analysis, interprets, identifies trends of scientific and process data per good document practices
Communicates with internal and external stakeholders scientific and process data and recommends path for forward processing
Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) and understands ‘why’ behind the regulations. Able to train, coach, mentor, mentors front line management and manage performance of othersto do the same
Identifies, communicates, addresses and improves complex cGMP compliance and regulatory gaps and issues across site
Follows and executes Standard Operating Procedures (SOPs)
Trains, coaches, mentors front line management and manages performance of others who execute SOPs
Revises, authors and reviews simple and complex SOPs
Standardizes and aligns SOPs
Improves the efficiency and execution of SOPs
Reviews and approves SOPs
Trains, coaches, mentors front line management and manages performance of others who execute BRs
Improves the efficiency and right-first-time (RFT) of BR execution
Standardizes and aligns BRs
Reviews and approves BRs
Accountable for ensuring front line management ensure associates are trained on SOPs, equipment, all unit operations and non-manufacturing SOPs and systems
Communicates training needs
Makes suggestions to the training program
Authors, reviews and approves technical documents such as non-conforming events and deviations
Teaches, coaches, mentors front line management and manages performance of others participating, providing information and authoring technical documents
Possess basic computer skills and able to efficiently use basic Microsoft applications
Suggests, participates, leads, implements and sponsors continuous improvement ideas
Teaches, coaches and mentors front line management of others to identify, suggest, participate and lead continuous improvement ideas
Identifies, participates, suggests solutions and leads complex technical problem solving
Teaches, coaches and mentors others to solve technical problems
First line decision maker for technical problems
Identifies, suggests with options, recommends path forward and leads complex decision making sessions
Teaches, coaches and mentors front line management on how to make decisions
First line decision maker for issues that require decisions
Delegates work assignments
Accountable for schedule preparation, forecasting, adjustments and performance of work assignments for team to ensure adequate staffing across site specific programs and site
Teaches, coaches and mentors front line management to delegate, prepare the schedule and how to make adjustments to assign and perform work
Participates, supports, assists as an SME, leads, resolves conflict, presents and represents 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, deals with problems and is the first line manufacturing decision maker with groups that support manufacturing in a cross functional manner
Cross trains in other areas and may be utilized to perform above job functions across the entire site
Has basic financial knowledge and acumen
Delivers performance efficiencies to impact assigned program and site specific programs, department and site gross margin
Performs well under direct supervision and works independently on complex tasks and processes
Manages the manufacturing process, projects and people
Train, coaches and mentors front line management on how to lead and oversee manufacturing processes
Accountable for departmental and performance management
Regularly holds 1:1s with direct reports and skip level meetings
Regularly holds staff meetings
Identifies and prioritizes escalations
Evaluates, recommends and makes decisions on hires, transfers, promotions and discharges
Demonstrated Lean / Six Sigma knowledge desired
Accomplishes staff results by communicating updated organizational information, job expectations & supporting their work
Plans, monitors, and appraises direct reports including performance competencies, goals & job results
Coaches, counsels, and conducts disciplinary actions
Develops, coordinates, and follows organizational systems, policies, procedures, and follows labor and capacity standards
Qualifications
Education:
HS Diploma or equivalent required and
5+ years relevant technical experience and min 2 years Managing people
BS/BA in Science related field preferred; or combination of relevant Experience &Education
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)
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Job Locations US-PA-Philadelphia
Job ID 2024-12775