Head of Process & Technology

Req #: 1803457
Location:Boudry, NeuchatelCH
Job Category:Manufacturing/Technical Operations
Work Location: Route de Perreux 1 BOUDRY 2017
Organization: Celgene International SaRL
Schedule:40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:Switzerland- Boudry

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Responsibilities will include, but are not limited to the following:

• Provides technical direction and expertise and support to Manufacturing Operations to improve capacity, quality, cost or to establish root cause.


• Leads and delivers a programme key improvements/projects across the manufacturing network (both internal and external) through the deployment of the appropriate technical expertise.


• Develops expertise and scientific understanding of key Pharmaceutical Operations and apply this understanding to optimize/improve Manufacturing processes. Assist with the development and implementation of control strategies.


• Leads and develops an Innovation and New Technology Programme of Manufacturing Technologies.


• Actively markets/advocates the capability of new technologies and approaches. Build business cases to support the development and application of these technologies. 


• Owns and ensures the Technology Transfer Process delivers quality products and knowledge into and out of Global Commercial Supply.


• Builds and manages internal and external relationships (GS, R&D, academia, regulatory authorities, suppliers, industries) targeted to develop and implement strategies to leverage new technologies and scientific understanding. 


• Responsible for allocating appropriate resources on key priorities / immediate need across our network (investigations, due diligences,…)


• Directs team to deliver strategic projects (such as the Technology Transfer of a product from Development) from project initiation to closure including after action reviews.


• Advocates best practice project methodologies and tools. Reviews project documentation including project plans, test protocols, risk assessments and reports.


• Proactively advocates the use of best practice, QbD, Lean and 6 Sigma methodologies.


• Responsible for expanding and continuously updating a scientific knowledge base. Advises on Scientific and Business developments (including Technology, Processes, Regulations etc).


• Development of Standards, guidelines and SOP’s to enhance the quality and robustness of our manufacturing operations, knowledge transfer and technical support processes.

Skills/Knowledge Required:

• Degree in Engineering, Chemistry, Pharmacy or Natural Science. At least 15 years’ experience in Pharmaceutical/Biotechnology development or production.


• 10+ years of leadership experience (team leadership, functional or discipline leadership).


• Experience in the development/application/introduction of new technologies and the regulatory pathway/hurdles (including QbD).


• Excellent working knowledge of QA, cGMP and the Pharmaceutical Regulatory framework


• Good knowledge of various types pharmaceutical Manufacturing processes/technologies.


• Excellent knowledge of Technology Transfer and validation.


• Extensive experience in Trouble Shooting/Root Cause analysis


• Demonstrated project leadership/management experience. Experience of multi-site/cross-site project management.


• Excellent knowledge QbD, Lean and 6 Sigma methodologies.


• Excellent leadership skills and ability to influence and work across organizational boundaries.


• Effective communication skills, good command of English and preferably another European language.


• Ability to manage and or to work well as an integral part of a large Project Team.

#LI-POST