External Manufacturing Lead

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Date: Aug 16, 2019

Location: Tokyo, Tokyo, JP

私たちの挑戦に、あなたの力を。

*This position requires high business English and Japanese skill*

*Please submit Japanese/English resume combined into one doc*

*Candidate must have working orking experince at Factory Site

※日本語履歴書と職務経歴書を一つに纏めてご登録ください。

※製薬工場での職務経験 必須。

 

【募集職種】

1/ The External Manufacturing Lead is accountable for leading the operational management of UCB's selected global Contract Manufacturers / strategic vendors.  In this context, the position leads the UCB Vendor Teams with members of Supply Chain, Quality Assurance, and global support functions in the pro-active monitoring of the performance of selected partners in order to assure continuous supply of compliant products and services. Additionally, this position leads tactical related projects such as technology transfers, new product introductions, process improvements,etc.

He is the key person of contact for the CMO/vendor for all issues related to the management of operations

 

2/ The External Manufacturing Lead participates in the development and implementation of the UCB industrial manufacturing strategy :

- evaluation of external manufacturing capabilities and capacities for CMO being (or not) part of the UCB external network and located in Japan.

- Support the Head of External Manufacturing DP&Device for the preparation of due diligence.

- input in preparation and evaluation of business cases (make or buy policy)

- preparing and recommending outsourcing and network footprint decisions

- Maintain strong link with development and patient solution teams to advise on and ensure required capabilities for future launches of new products (costs, reliability, compliance, Regulatory) when third parties are involved.

- Advise technical teams on new technologies

【職務内容】

 

1/ Lead CMO vendor teams to perform day to day operational management of selected CMO's.  Facilitate periodic meetings between CMO's and UCB extended vendor team . 

2/ Participate in the CMO selection for new and existing products (new products in cooperation with PST's or Life Cycle Management) within the UCB manufacturing network and support establishment of business and quality contract

3/ Deliver technical expertise to support UCB CMO's in order to ensure effective processes, optimize capacity utilisation and respect of quality standard .  Lead project groups, if relevant.

4/ Perform 1st line troubleshooting (deviation) at CMO's in scope and lead investigations and CAPA in case of complex, business relevant technical and supply issues. Support the implementation of CMO change control in a Coordination or project leader role into the UCB Vendor Team

5/Perform product reviews and CMO performance review together with QA, Supply Chain, Strategic Alliance and Purchase. Support contract compliance check initiative when relevant.

6/ Monitor capacities and implement long range capacity plans in coordination with Supply Chain

7/ Deliver Technical Expertise for Continuous Improvement of CoG's during the life cycle of all products in scope

8/ Lead multifunctional teams to ensure tech transfers, validation, investigation and business support activities to/from CMO's for existing and new products  Support regulatory submissions related to these projects.

9/ Drive CMO risk analysis and implement identified mitigation plans

10/ Develop and evaluate business cases and prepare recommandations for make or buy of respective products

11/ Maintain and share technology knowledge and CMO market intelligence.Maintain the technical knowledge of  manufacturing processes currently used at CMOs in scope.

 

【必要なスキル・経験】

- Working experince at Factory Site

- Significant Operation management in GMP environment (DP manufacturing) : 5 years

- International Exposure in pharmaceutical project management

-Experience in External Manufacturing is an advantage

- Strong technical knowledge on DP oral solid form / injectable bulk manufacturing and packaging.  

 

 

- Fluent in Japan and English (written &spoken)

- Ability to lead multi-functional teams, influence others, hold teams accountable, results orientated, effective at networking, able to manage complex projects from development through commercialization and to attain results.

- Must be able to manage external business partners and relationships to influence partners to deliver results that UCB needs.

- Relationship management – internal/external

- Communication and networking external and internal

- Non hierarchical management skills (persuasion)

- Project Management

- Basic financial & business knowledge

- available to travel to Belgium several times per year

【勤務地】

東京本社(西新宿)

 

【給与】

年俸制

 経験・能力等を考慮の上、決定

 社内規定に準じます 

 成果に応じて昇給あり(年1回)

通勤交通費別途支給

 

 

【福利厚生】

退職年金・団体生命保険・定期健診・各種社会保険・財形貯蓄制度

 永年勤続表彰・クラブ活動・英語学習補助

 

【休日休暇】

週休2日制(土・日)

 祝日・夏季休暇・年末年始休暇・有給休暇・慶弔休暇・特別休暇

 

【勤務時間】

フレックスタイム制 (コアタイム無し) 7.5h×月間所定労働日数で清算

 昼休み 1時間

 


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