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 is:
Week 1: Wed – Sat: 12:00 pm – 11:30 pm Week 2: Thurs – Sat: 12:00 pm – 12:30 am 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 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.
