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). Work schedule is Wednesday - Saturday 2:00pm - 12:30am.

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
• 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.