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).
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
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