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).
Please note the shift and schedule for this role: Sunday - Tuesday with alternating Wednesday: 2:00pm - 2:30am
Responsibilities• Understands, oversees, trains, coaches, mentors and manages performance of others on basic aseptic operational techniques as well as, performing solution, material preparation, analyzing results and facility start-up engineering and mechanical knowledge.
• 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
• Reviews and approves solution and material preparation results and resolves issues
• Reviews 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 during phases of technical transfer
• Executes in-house and offsite validation activities
• Forecast and performs material procurement activities
• Uses all support systems (e.g. LIMS) with demonstrated proficiency and able to act as an subject matter expert (SME) and/or Super user on a system
• Acts a lead, member or Champion 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 and manages performance of others on basic operations such as media preparation, thaw, passage and harvesting and specific unit operations and overall systems across assigned programs, in the manufacturing process
• Interprets data and draws conclusions
• Identifies process and method gaps and opportunities and implements improvements across assigned programs and site specific
• 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
• Identifies, communicates, addresses and improves complex cGMP compliance and regulatory gaps and issues across assigned programs and site specific
• Responsible for ensuring employees are trained on Batch record, SOPs, equipment, all unit operations and non-manufacturing SOPs and systems
• Authors, reviews and approves technical documents such as non-conforming events and deviations
• Identifies, suggests, participates, leads, implements and champions continuous improvement ideas
• Accountable for schedule preparation, forecasting, adjustments and performance of work assignments for team to ensure adequate staffing across assigned and site specific programs
• Regularly interacts with and supports cross-functional teams.
• 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
• HS Diploma or equivalent required and
• 5+ years relevant technical experience and min 2 years in a Lead/Leadership/Supervisory Role
• BS/BA in Science related field preferred; or combination of relevant Experience & Education
Knowledge / Skills / Abilities:
• Demonstrated Lean / Six Sigma knowledge, desired
• 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
• Has basic financial knowledge and acumen
• Possesses basic and fundamental engineering and mechanical knowledge and is able to apply in the manufacturing area demonstrating unit operational and end-to-end understanding
• Possesses technical knowledge and background in the pharmaceutical and biotechnology industry, specifically in cell and gene therapy.
• Proficient in Oral & Written communication skills
• Need to be able to read, write and understand English
• Proficient in Microsoft (Excel, Word, Outlook)
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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