Supervisor Manufacturing
1 month ago
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.
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).
Work schedule: Sun – Wed: 7:00 am – 5:30 pm
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
Develops, coordinates, and follows organizational systems, policies, procedures,
and follows labor and capacity standards
Qualifications:
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 isable to apply in the manufacturing area demonstrating unit operational and endto-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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