Responsible for providing direct support and overall leadership to the manufacturing of Master and Working Cell Banks, Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs). Scope includes management of teams responsible for quality systems which include but not limited to investigations/deviations/non- conforming events, action plans, CAPAs, change controls and protocols.
- Support daily operations in the manufacture of the following: Cell Banks, Viral Vectors, Cell Therapy, and Gene Therapy products following Current Good Manufacturing Practices.
- Team formation o Build a technical and scientific team focused on supporting and improving operational performance in aspects of process and human performance. o Develops team technically, to investigate using various tools, with verbal and written communication and with lean and six sigma methodology. o Staff, train, coach and develop employees within area of responsibility. o Develop processes to manage metrics as a means to monitor and improve performance.o Recommends hire/transfer/promotion/discharge and salary changes and acts on problems of direct reports.o Conducts employee performance appraisals in a timely and objective manner.
- Quality Systemso Reviews quality systems to ensure compliance, robustness and to identify areas of opportunity for coaching and improvement.o Participates, coaches and may lead complex quality system performance.o Develops systems and metrics to coordinate and communicate in order to execute quality systems of good quality that meet time expectations.o Prepared to present quality systems during regulatory inspections and audits.
- Technical supporto Develop a team that provides technical support with routine manufacturing, aids in troubleshooting through process monitoring, trending and risk identification and process improvement to achieve safe, compliant and cost effective production to deliver upon client contractso Provides leadership to a team that leads complex technical investigations, CAPA/action plans and change controlso Provides support to late stage programs in support of commercialization efforts.o Supports commercial programs through the performance of process monitoring, trending, comparability and controls, issue resolution, improvement, optimization and life cycle management
- Process technology transfero Partners with Process Development, client and other internal and external stakeholders in support of Manufacturing in the evaluation of incoming client projects/program to WuXi and from Process Development to Manufacturing.o Helps support Manufacturing in the enhancement of service offerings.
- Technical support and troubleshooting of routine manufacturing, technical investigations, CAPA/Action Plan, and Change Control leadership.
- Process technology transfer, process issue resolution, improvement, optimization and life cycle management.
- Process monitoring, trending, comparability and controls. Support late stage studies, validation, characterization and robustness, production and regulatory filings in support of commercialization efforts.
- Accountable for departmental and performance management.
- Regularly holds 1:1s with direct reports and skip level meetings.
- Regularly holds staff meetings.
- Demonstrated Lean / Six Sigma knowledge desired.
- 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.
- Contributes to the overall operations and to the achievement of departmental. goals.
- Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
- Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices.
- May be required to work Holidays and weekends.
- May be required to work Overtime.
- May be required to work outside of normal business hours.
- Other duties as assigned.
- BS/BA in Science related field preferred; or combination of relevant Experience & Education
Knowledge / Skills / Abilities:
- Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
- Clarity of vision at near and mid-ranges (less than 20 feet), depth perception and ability to identify and distinguish colors.
- Must be able to wear appropriate clean room attire (i.e. surgical masks) and all Personal Protective Equipment (PPE).
- Works in production environment with exposure to latex and bleach. Potential exposure to noise and equipment hazards (i.e. vacuum pumps, pressurized vessels), dangerous materials (i.e. chemicals, solvents, pathogens), freezer burns, allergens and strong odors.
- Based on work assignment, may be recommended to have medical testing in accordance with the company’s Occupational Health Program.
- Holiday and shift work often required based on manufacturing schedule as determined by Management.
- Proficient in Oral & Written communication skills.
- Need to be able to read, write and understand English.
- Proficient in Microsoft (Excel, Word, Outlook).
- Ability to lift 40 lbs routinely.
- Ability to crouch, bend, twist, and reach.
- Ability to push/pull 40 lbs routinely/ often / occasionally.
- Clarity of Vision.
- Must be able to perform activities with repetitive motions.
- Ability to climb Ladders / Stairs / Scaffolding.
- Ability to work in variable temperatures high to freezing.
- Inside/outside working conditions.
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Executive / senior industry position
Philadelphia , United States