WuXi AppTec Group
Overview
WuXi AppTec is a trusted partner and contributor to the pharmaceutical and life sciences industries, providing R&D and manufacturing services that help advance healthcare innovation. With operations across Asia, Europe, and North America, we offer integrated, end-to-end services through our unique CRDMO (Contract Research, Development, and Manufacturing Organization) platform.
Guided by our vision that every drug can be made and every disease can be treated, we are committed to advancing breakthroughs for patients—one collaboration at a time. Learn more at www.wuxiapptec.com
STA Pharmaceutical Switzerland is part of WuXi AppTec. The site is located in Couvet, Canton Neuchatel, in Switzerland and manufactures oral drug productsfor global markets. STA Pharmaceutical - Couvet
In this
Associate Director Technical Operations
role, you will be using your strong OSD Drug Product technical skills to ensure the successful transfer of Drug Products to the Couvet site, Switzerland. This includes the on-time-in-full supply of technical, registration, clinical, stability, and PPQ batches
This position report to the Vice President, Head of Late-Stage Formulation R&D and Commercialization, and Head of Business Development for China
Responsibilities Accountability for the successful transfer of OSD Drug Products:
Accountable for the on-time start of bulk manufacturing and packaging batches
Accountable for the on-time delivery of registration, clinical and stability batches
Selection and evaluation of process technology, tooling and methods
Design, modification, assembly & setup of equipment
Development, determination and optimization of process parameters
Devise tests before and during production
Collection and analysis of process data
Enabling the execution and troubleshooting of production
Technical working instruction (including batch records) of various manufacturing technologies to ensure the production operation is compliant with the GMP policy and to satisfy the highest safety standard.
Support deviations by leveraging technical expertise, manufacturing experience, and investigation skills
Provide technical trainings and seminars to personnel of other departments to promote the application of new manufacturing technologies, and to resolve any misconception and miscommunication.
Accountable for process validation (PPQ), including Continued Process Verification
Accountable for cleaning validation, including routine spot checks, cleaning verification and the annual review
Managing the Department :
Guide, mentor & develop your teams to achieve an environment of personal accountability and trust.
Ensure proactive priority and daily activity management for team & activities (planning communication, team organization, control, checking of the defined targets),
Ensure department processes are sufficiently defined and documented. KPIs are implemented & monitored, actions are prioritized to ensure KPIs are on target.
Ensuring responsibilities are clear
Qualifications
Bachelor degree or above combined with15+ years experience in a pharmaceutical execution and management position
10+ years experience of OSD DP processes and management requirements
Solid working knowledge of global regulatory requirements (US, EU, etc.) & best practices including SUPAC
Excellent Leadership skills, including coaching and motivating teams.
Outstanding communication management and stakeholder management
Ability and drive to strive in a fast and dynamic work environment
Excellent organizational skills
Fluent English. French or Chinese a strong plus
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Guided by our vision that every drug can be made and every disease can be treated, we are committed to advancing breakthroughs for patients—one collaboration at a time. Learn more at www.wuxiapptec.com
STA Pharmaceutical Switzerland is part of WuXi AppTec. The site is located in Couvet, Canton Neuchatel, in Switzerland and manufactures oral drug productsfor global markets. STA Pharmaceutical - Couvet
In this
Associate Director Technical Operations
role, you will be using your strong OSD Drug Product technical skills to ensure the successful transfer of Drug Products to the Couvet site, Switzerland. This includes the on-time-in-full supply of technical, registration, clinical, stability, and PPQ batches
This position report to the Vice President, Head of Late-Stage Formulation R&D and Commercialization, and Head of Business Development for China
Responsibilities Accountability for the successful transfer of OSD Drug Products:
Accountable for the on-time start of bulk manufacturing and packaging batches
Accountable for the on-time delivery of registration, clinical and stability batches
Selection and evaluation of process technology, tooling and methods
Design, modification, assembly & setup of equipment
Development, determination and optimization of process parameters
Devise tests before and during production
Collection and analysis of process data
Enabling the execution and troubleshooting of production
Technical working instruction (including batch records) of various manufacturing technologies to ensure the production operation is compliant with the GMP policy and to satisfy the highest safety standard.
Support deviations by leveraging technical expertise, manufacturing experience, and investigation skills
Provide technical trainings and seminars to personnel of other departments to promote the application of new manufacturing technologies, and to resolve any misconception and miscommunication.
Accountable for process validation (PPQ), including Continued Process Verification
Accountable for cleaning validation, including routine spot checks, cleaning verification and the annual review
Managing the Department :
Guide, mentor & develop your teams to achieve an environment of personal accountability and trust.
Ensure proactive priority and daily activity management for team & activities (planning communication, team organization, control, checking of the defined targets),
Ensure department processes are sufficiently defined and documented. KPIs are implemented & monitored, actions are prioritized to ensure KPIs are on target.
Ensuring responsibilities are clear
Qualifications
Bachelor degree or above combined with15+ years experience in a pharmaceutical execution and management position
10+ years experience of OSD DP processes and management requirements
Solid working knowledge of global regulatory requirements (US, EU, etc.) & best practices including SUPAC
Excellent Leadership skills, including coaching and motivating teams.
Outstanding communication management and stakeholder management
Ability and drive to strive in a fast and dynamic work environment
Excellent organizational skills
Fluent English. French or Chinese a strong plus
#J-18808-Ljbffr