- Maintaining skills in assigned core capabilities for example, but not limited to, documentation practices, quality and regulatory compliance, data integrity, change management, GPM, lean capabilities & product security.
- Management of product knowledge throughout the lifecycle.
- Maintain technical knowledge in area of subject matter expertise including up to date advances in new technologies to aid in the improvement of pharmaceutical processes and or methods.
- Regulatory file authoring, review, license renewals and response to questions.
- Provision of technical leadership to support product supply strategy projects (sourcing, asset transfers, capacity expansion, etc.) and business continuity plans through delivery of the drug product control strategy, manufacturability strategy and product quality risk management activities throughout the lifecycle.
- Responsible for the technical support during the transfer of established products within sites and to external manufacturing partners including support for equivalency determination as applicable.
- Support complex technical improvements or change activities assuring product performance including extractables and leachable assessments, nitrosamines risk assessments and risk assessments of elemental and organic impurities.
- Support for drug product PPQ programs in the support of transfer and change activities.
- Provision of technical problem-solving expertise to aid in the resolution of manufacturing/method/formulation issues & complaints impacting supply or manufacturability.
- Assist in the development of CAPAs to eliminate root cause(s).
- Responsible expert for a commercial product or group of commercial products related to the Pharmaceutics subject matter area.
- Responsible for lifecycle activities to ensure equivalence across sites e.g., specifications, methods, processes.
- Leads Global review of product performance via appropriate dashboards/CPV assessments to ensure product and process robustness.
- Support for defining technical standards impacting commercial products specific to regulatory expectations and good business or quality standards (including pharmacopeial standards).
- Provision of training in subject matter expertise areas.
- May be the product lead for one or more products coordinating TOSI activities and being the point of contact for general matters for these products as well as representing TOSI in the Global Supply Teams (GST) and/or Pharmaceutical Teams (PT).
- Executing Technical leadership and influencing in Pharmaceutical Teams and within TOSI.
- Develop and manage a prioritized portfolio of TOSI project activities, with appropriate demand and supply oversight.
- Ensure ( in collaboration with TOSI SPOC) effective collaboration between PT&D and the AZ sites/External Supply Management (ESM) managed sites and Global Partners.
- Maintain a technical support model with outstanding customer service for all AZ manufacturing sites and external manufacturing/testing partners.
- Build effective networks across the Global Operations organisation.
- Lead and assess impact of complex technical improvements or change activities assuring product performance including extractables and leachable assessments, nitrosamines risk assessments and risk assessments of elemental and organic impurities.
- Develop solutions to a diverse range of problems requiring complex judgements based on highly developed levels of conceptual thought, strategic vision and analysis.
- Technical leadership to Issue Management Team (IMT).
- Project resource estimations to support the budgeting process.
- Responsible for the assessment of impact and management of the decision making process across functions for issues spanning across sites and functions outside of PT&D.
- Coaching of technical experts across PT&D in subject matter areas.
- Identify cross product or brand challenges or opportunities for commercial drug products.
- Leadership of technical strategic initiatives, networks or forums within the organization.
- Recognized externally as a technical leader with a track record of consistent delivery.
- Executing Technical Leadership and influencing across Operations and PT&D.
- Providing Technical Expertise to external partners and in external networks
- Create an effective partnership, manage expectations and resolve issues positively and in the best interest of AZ.
- Ensure that all work is carried out in compliance with AstraZeneca and external regulatory policies and standards.
- Continuously improve in competence, scientific excellence and innovation.
- Operate at the highest level of risk management.
- Be an excellent communicator with strong interpersonal skills in order to collaborate effectively with stakeholders.
- Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance.
- Have an excellent understanding of the overall drug development and commercialization process from development, launch and through life cycle management
- Likely to be educated to BSc, MSc or PhD level in an appropriate discipline 10+ years of experience relevant to the pharmaceutical industry experience and have professional credibility within the business and industry.
- Good communication skills in both Mandarin & English.
- Experience in or exposure to multiple disciplines in CMC and related functions (eg Development, Manufacturing, Global Supply, Marketing Companies)
- Have in depth understanding of their multiple disciplines, such as, analytical, formulation, process engineering, modelling or validation.
-
InsideHigherEd Suzhou, 中国 Faculty Jobs ,School: Academy of Pharmacy · Position: Faculty [Open Rank] · Location: Suzhou, China · Contract Type: Fixed-term, renewable. 3rd contract is open-ended · ABOUT XJTLU · In 2006 Xi an Jiaotong-Liverpool University (XJTLU) was created by the University of Liverpool and Xi an Jiaoto ...
-
Business Analyst
4天前
AstraZeneca Wuxi, 中国 全职About the Operations IT Team · Operations IT is a global IT capability supporting the Global Operations Organization. We business partner with Operations capability areas: Pharmaceutical Technology Development, Manufacturing, Global Engineering, Quality Control, Sustainability, ...
-
AstraZeneca Wuxi, 中国 全职Responsibilities: · •Maintain / improve GMP compliance in daily Analytical Lab operation. · •Manage analytical lab technical supporting team and be responsible for team and personnel capability development · •Lead the initiatives for quality control procedure or management conti ...
-
HCM Process Engineer
13小时前
Lonza Suzhou, 中国如今,龙沙已成为生命科学领域的全球领导者,业务遍及三大洲。我们从事科学工作,这没有任何法宝可指导我们如何进行。我们最佳的科学解决方案便是汇聚人才,集思广益,助力发展我们的业务回馈社会。同时,龙沙员工也在此获得富于挑战的职业发展机会。他们大大小小的想法,都真正地促进了社会的发展。这就是我们希望参与其中的工作。 · 苏州胶囊有限公司成立于1986年,是Capsugel(隶属于Lonza集团)与中国国药集团共同出资建立的空心胶囊生产基地。三十多年来,苏州胶囊坚持采用Capsugel先进的胶囊制造和检测技术,遵循全球统一的质量体系,通过全自动化的控制操作、严格的 ...
-
Lonza Suzhou, 中国Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exc ...
-
821 GlaxoSmithKline Philippines Inc Suzhou, 中国 全职Are you looking for an opportunity to manage the integration of pharmaceutical brands and execute the marketing campaign to optimize the customer experience? If so, this is the role for you. · As Product Brand Management Pharmaceutical Professional, you will be responsible for al ...
-
Product Manager
1周前
821 GlaxoSmithKline Philippines Inc Suzhou, 中国 全职Are you looking for an opportunity to manage the integration of pharmaceutical brands and execute the marketing campaign to optimize the customer experience? If so, this is the role for you. · As Product Brand Management Pharmaceutical Professional, you will be responsible for al ...
-
InsideHigherEd Suzhou, 中国 Faculty Jobs ,School: Academy of Pharmacy · Position: Faculty [Open Rank] · Location: Suzhou, China · Contract Type: Fixed-term, renewable. 3rd contract is open-ended · ABOUT XJTLU · In 2006 Xi an Jiaotong-Liverpool University (XJTLU) was created by the University of Liverpool and Xi an Jiaoto ...
-
InsideHigherEd Suzhou, 中国 Faculty Jobs ,School: Academy of Pharmacy · Position: Faculty [Open Rank] · Location: Suzhou, China · Contract Type: Fixed-term, renewable. 3rd contract is open-ended · ABOUT XJTLU · In 2006 Xi an Jiaotong-Liverpool University (XJTLU) was created by the University of Liverpool and Xi an Jiaoto ...
-
InsideHigherEd Suzhou, 中国 Faculty Jobs ,School: Academy of Pharmacy · Position: Faculty [Open Rank] · Location: Suzhou, China · Contract Type: Fixed-term, renewable. 3rd contract is open-ended · ABOUT XJTLU · In 2006 Xi an Jiaotong-Liverpool University (XJTLU) was created by the University of Liverpool and Xi an Jiaoto ...
-
Product Manager
1周前
821 GlaxoSmithKline Philippines Inc Suzhou, 中国 全职Are you looking for an opportunity to manage the integration of pharmaceutical brands and execute the marketing campaign to optimize the customer experience? If so, this is the role for you. · As Product Brand Management Pharmaceutical Professional, you will be responsible for al ...
-
Avery Dennison Smartrac Suzhou, 中国 全职公司描述 · Avery Dennison Corporation (NYSE: AVY) is a global materials science and digital identification solutions company that provides a wide range of branding and information solutions that optimize labor and supply chain efficiency, reduce waste, advance sustainability, circul ...
-
821 GlaxoSmithKline Philippines Inc Suzhou, 中国 全职As a Marketing Manager, you will lead the strategic planning and execution of integrated multichannel campaigns for promoted portfolio products across the assigned region. · This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsib ...
-
Avery Dennison Smartrac Suzhou, 中国 全职Company Description · ABOUT AVERY DENNISON · Avery Dennison Corporation (NYSE: AVY) is a global materials science and digital identification solutions company that provides a wide range of branding and information solutions that optimize labor and supply chain efficiency, reduc ...
-
Allergan Aesthetics Suzhou, 中国 全职Job DescriptionDeliver sales performance, brand KPIs, financial targets, marketing objectives, etc. in order to meet or exceed on those objectives. · Create pre-call plan using SMART objectives and execute post-call evaluation in order to continuously improve sales performance. E ...
-
Haleon Suzhou Shi, 中国 全职Hello. We're Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we're improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren ...
-
Avery Dennison Smartrac Suzhou, 中国 全职公司描述 · Avery Dennison Corporation (NYSE: AVY) is a global materials science and digital identification solutions company that provides a wide range of branding and information solutions that optimize labor and supply chain efficiency, reduce waste, advance sustainability, circul ...
-
Lilly Suzhou, 中国 全职We're looking for people who are determined to make life better for people around the world. · 岗位描述 Position Brand Description: · 该岗位为工厂合规QA,负责通过构建、完善、执行和监督质量流程来保障工厂质量体系的全面合规性。持续监督本地法规、药品生产质量管理规范以及礼来公司全球质量准则要求的实施,并按适当的管控措施及时上报潜在合规性风险。 · This role serves as site Compliance QA, ...
-
Haleon Suzhou, 中国 全职Hello. We're Haleon . A new world-leading consumer health company. Shaped by all who join us. Together, we're improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltare ...
-
Lilly Suzhou, 中国 全职We're looking for people who are determined to make life better for people around the world. · 该岗位是负责无菌保证组和环境监测组的区域质量保证人员,负责确保无菌保证项目符合法规要求。 · This role is the area QA for TS/MS Sterility Assurance and Environmental Monitoring group, responsible for ensuring the sterility assuranc ...
Principal Scientist – Pharmaceutical Sciences - Wuxi, 中国 - AstraZeneca
描述
The role holder is responsible for providing expert technical support to commercial products manufactured internally at AZ sites and externally at contract facilities.
General Responsibilities include:
Specific Responsibilities include:
The role holder will
All these activities will have a significant impact on the overall success of Operations as well as ensuring the commercial viability of current products. The activities of the TOSI organization help to ensure availability of all AstraZeneca products to the commercial organization. The role, therefore, has a significant impact on both financial and reputational aspects of the business.
Education, Qualifications, Skills and Experience
Essential
Desirable
Date Posted
07-3月-2024Closing Date
