北京招聘

Introduction:

The Technical Operations is part of Janssen Supply Chain (JSC) of Johnson & Johnson. This

Pharmaceutical Division (TO) is a worldwide organization with members located in the United

States, Europe, and Asia Pacific in close vicinity to the Internal Manufacturing Network (MTO)

and External Manufacturers sites. Providing Technical Competence and Manufacturing

Excellence to Johnson and Johnson’s pharmaceutical environment and product portfolio is the

primary focus of TO organization.

Technical Operations is organized in different platforms, each specialized in a defined

pharmaceutical science field (Solids, Parenteral’s, liquids & Cream, Devices & Packaging,

….etc.). It functions by assuring and providing technical and scientific support for:

a. Life Cycle Management

b. External/Internal Manufacturing Strategy and Network Configuration

c. External / Internal Manufacturing Support

i. New Product Introduction

ii. Technology Transfer

iii. Trouble shooting escalation support

iv. Technical training

v. Major Cost Improvements and Sites Support

vi. Products Trending and investigations

d. Design to Value Strategy and Manufacturing Network readiness

e. Localization support

f. Process/Equipment Standardization

g. Innovation→New Technology

h. Strategic Business Strategy (L&A and M&A) support

Description:

The Scientist/Engineer of Technical Operations has main responsibilities to specifically focus on

External manufacturer / Third-Party Manufacturer located in the Asia Pacific region.

Responsibilities:

? Contribute in Developing and deploys technology standards and its applications through assets and

products

? Provides technical expertise to External manufacturing in ensuring product end to end life

cycle Management

o Technically support product life cycle management (investigation, troubleshooting

etc.) partnering with VCM, CMC, PDMS and all JSC functions

? Provide expertise and resources to other TO platform, upon request, acts as a technical co-

ordinator to external manufacturing group / SBS for technical scouting and due diligence

for the current product portfolio / in-licensing.

? Owns and executes Initiatives and projects related to network reconfiguration, major cost

improvement programs, process improvements, implementation of new capabilities and

capacity

? Contributes to business planning strategies in partnership with PES Manufacturing and

PES Regional Lead and translates business goals into project objectives.

? Develop relationships with Key Stakeholders, like PES Regional Lead, PES Site Lead,

ESI-Q, PDMS, TO Platforms, Quality, VCM, CM, PM …...

o Provide and organize technical expertise to External Manufacturing in ensuring

consistent production of J&J marketed pharmaceutical products manufactured by

External manufacturer / Third Party Manufacturers.

o Act as a technical co-coordinator and consultant to the PES, PM and CM organizations

to support technically in the scouting and due-diligence for the current product portfolio

existing in external manufacturing

o Provide technical expertise to the CM and PES organizations for localization /

Glocalization and supporting in due diligence of facility and products/ process fit

technical assessment.

o Assess and support, in agreement with PDMS organization (R&D), the execution for

technical manufacturing process /formula modifications and introduction of New

Product and Second Generation Development (in alignment with TLI or assuming the

role of TLI/DPTO).

o Assess and support PDMS in innovation of new technology scouting, novel

manufacturing etc.

- Support technical assessment,

- Building business case,

- Support the implementation.

? Lead the Technology Transfer activity of drug products as per regional Guidelines & J&J

Quality Standards according to approved budget and timeline;

o Prepare and ensure technical project scope and align with all stakeholders during project

definition and execution

o Prepare and drive timely decisions within the project team and with relevant commercial and

operational management

o Prepare, support and execute local and regional technology transfer projects in terms of project

risks, budget, quality/scope and timings according to state-of-the art project management

methodology

o Execute the Process Validations/PPQ as part of Technology Transfer in cGMP environment.

o Execute introduction and transfer of products to External manufacturer / Third Party

manufacturers for worldwide supplies / regional supplies.

o Execute Technical Assessment & subsequent implementation for minor technical

manufacturing process modifications as requested by the Manufacturer or Commercial groups

? Strives for developmental opportunities and initiates / proactively seeks for corrective

actions as necessary.

Qualifications:

? University Degree (M.Pharm / M.Tech in Pharmaceutical Sciences, or Pharmaceutical

Engineering, Chemistry or Engineering).

? Fluent in English and with fluency in another major regional language desirable.

? 8-10 years of experience in Pharmaceutical Development, Scale up, Technology Transfer

and /or manufacturing on oral dosage form and topical presentations in the region, in at

least two different functions.

? At least two years’ experience in External manufacturing /Third Party Technology

Transfers and project management is desirable.

The candidate should have the following qualities and core competencies:

? Profound Technology understanding of

o The following final dosage presentations (minimum of two): Oral Dosage forms

(Solids and Liquids), Semi-solids, or Parenterals & Transdermal drug delivery systems

o Pharmaceutical development of the following Oral Dosage forms (minimum of two):

Solid Orals, Liquid Orals, Semi solids, Parenterals & Transdermal drug delivery

systems (Minimum of two)

o Global, and Regional regulatory requirements

o Fair knowledge on Product development/scale up/technology transfer regulations

pertaining to ICH/USFDA/EMEA/Asia Pacific

o Knowledge on regional pharmaceutical manufacturing environment for Asia Pacific

o Good Manufacturing Practices, quality and compliance

o Process Validations / PPQ / CPV

o Cleaning validation

? Can prepare strategy and business case for technology transfer projects together with

external manufacturing team and operating Companies

? Understands the needs of the Manufacturing Excellence Locally and Regionally and its

platform

? Applies state-of-the-art project management methodology to manage project risks, budget,

quality/scope and timings

? Can drive execution of project activities in the project team without formal reporting lines

? Can communicate and network across functions, regions and cultures, especially Asia

Pacific and Europe / US

? Shows sense of urgency

? Stays motivated and achieves results in complex organizations with unclear decision-

making processes and responsibilities

? Wants to establish contacts with people from different functions and from different regions

and cultures

? Is willing to travel as required by the business and to work outside regular business hours

? Is willing to adjust to different cultures and personalities

? Balances requirements for quality / compliances / science with business needs.

强生是全球具综合性、业务分布范围广的医疗保健企业，业务涉及消费品、制药、医疗器材三大领域，1985年在华创立了***家合资企业。强生遵循企业信条的价值观，致力于践行“关爱全世界,关注每个人”的健康愿景，以领先的科技研发创造创新的理念、产品和服务，为改善人类健康和福祉而不懈努力。每天，强生遍布世界各地的员工，与他们的合作方一起，为全球消费者和病患带来更健康、更快乐、更长寿的生活。
强生于1985年在华创立了***家合资企业。 多年来，强生不断发挥行业领军作用，以创新、高质量的产品和服务，为中国亿万家庭带来健康。如今，强生在中国的业务涉及消费品、制药、医疗器材三大领域，在北京、上海、广州、苏州、西安等90多个城市，拥有员工总数近10,000人。强生在西安高新技术产业开发区投资兴建先进的大型生产基地，以更好地服务中国和亚太地区其他国家。
强生是***在中国成功实现“端到端”研发模式的跨国企业；并通过实现从早期研发到临床应用，致力于加速中国创新产品的研发，促进中国创新型经济的发展。强生的三大业务领域在中国均设有研发机构, 并在上海建立了强生亚太创新中心，将源自于中国和亚太区域的创新成果推向国际市场。
该创新中心是强生深化外部合作战略的主要窗口。强生将密切与创新企业、学术和科研机构，以及优秀人才的合作，通过提供资金、专业知识和技术，共同将雏形创新转化为医学临床应用的成果，强生并在中国建立全球肺癌研究中心，以满足中国及国际市场的需求，造福病患。
强生心系中国的发展和进步，致力于成为优秀的企业公民。强生积极参与各类重大活动，助力中国的社会经济发展， 并荣幸的成为2008年北京奥运会及残奥会和2010年上海世博会美国馆的全球合作伙伴。
为加强对中国市场的承诺，强生于近期部署了中国发展新战略。强生将融汇全球的资源、凝聚在华的核心业务能力，更加稳健的迈开公司积极创新、完美执行和锐意领先的步伐，为中国创造更多价值。
强生多次荣获《巴伦周刊》“全球最受尊敬企业”的荣誉，充分体现了强生始终以实际行动改善人类健康福祉的不变理念。
2017年，强生连续第33年入选美国《财富》杂志发布的全球最受赞赏企业排行榜，位列总榜第13名，居全球制药行业榜首。