Principal Scientist Process Analytical Technologies Analytica…

【求人No NJB2257557】
Job Description
”Better Health for People Brighter Future for the World” is the purpose of a company. We aim to create a diverse and inclusive organization where people can thrive grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transform the lives of patients. We’re looking for like minded professionals to join us.

Takeda is a global values based R D driven biopharmaceutical leader. We are guided by our values of Takeda ism which has been passed down since the company’s founding. Takeda ism incorporates Integrity Fairness Honesty and Perseverance with Integrity at the core. They are brought to life through actions based on Patient Trust Reputation Business in this order.

As a Principal Scientist in Analytical Development ・ Process Analytical Technologies （PAT） group it is expected that the individual will independently contribute and lead efforts in process analytical technologies in global AD partner with synthetic molecules and biologics process/product development teams and data scientists and drive cross functional interactions across Pharmaceutical Sciences to deliver on program strategy. The individual is expected to have expertise in multiple areas of process analytical technologies including design development and implementation and demonstrates working knowledge of other Pharmaceutical Science roles and deliverables.


How you will contribute:
Independently design and execute diverse range of process analytical technologies to develop optimize monitor model and control pharmaceutical processes with emphasis on continuous processing of drug substance and drug products.

Expertise with inline spectroscopic methods （UV IR Raman） and chemometrics is required.

Familiarity of regulatory requirements （ICH Q2/Q14） for analytical method qualification and validation are desired.

Analytical control strategy/comparability knowledge of existing offline and online/inline methods to facilitate bridging away from the current standard.

Expected to independently propose and implement resolutions to complex technical challenges.

Responsible for significant or sole technical leadership within own program（s） provide technical guidance related to expertise across programs delivering to organizational DDT （Digital Data and Technology） strategies.

Serves as a technical resource within function mentoring and training junior employees across multiple technologies.

Reviews and interprets complex data communicating clearly to functional leadership and relevant line functions.

Leads technology transfer internally and externally building key vendor relationships.

Able to develop project strategy within AD and cross functionally and guide junior staff.

Prepares documentation for regulatory filings authors technical reports may author publications.

Able to work on multiple programs and represent AD within PS/project teams.

Complete all required training appropriate to role and function in a timely manner.

Minimum Requirements/Qualifications:

Bachelors degree with 10+ yrs relevant experience Masters degree with 8+ yrs relevant experience Ph.D. with 4 yr relevant experience

Competent in multiple analytical techniques with advanced knowledge in specific analytical and real time monitoring techniques relevant to analytical function understands wider PS deliverables and project timelines.

Able to communicate complex data clearly able to work cross functionally good scientific writing skills able to work independently with minimal supervision

Good command of English language is required