Posted to MedZilla on 3/26/2017


Takeda Pharmaceuticals

US-MN, Development Associate II, Technical Operations, Analytical 1700646-MZ


 
 

More than 30,000 Takeda employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, central nervous system and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.
While Takeda is enjoying tremendous growth as an emerging global leader in the pharmaceutical industry, we remain ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine. In short, we are a passionate team doing important work that impacts patients lives. If you are driven to create better health and a brighter future, join us!

OBJECTIVES:

  • The Brooklyn Park facility is being prepared for transfer and commercial production of Entyvio and other monoclonal antibodies
  • The Technical Operations Group is responsible for leading tech transfer of the products into the facility at bench and pilot scale and subsequently to commercial scale
  • The group is additionally responsible for manufacturing technical support including batch records, deviations, change controls, investigations, life cycle management, scale down modeling, satellite runs, process validation, data tracking and trending, and supporting CMC regulatory filings
  • In addition to participating in the above activities, the current position will be responsible for performing hands-on support for the analytical assays that are commonly used to assess the purity, identity, safety, potency and structure of the drug substances and drug products and actively participate in workstreams and project teams.

ACCOUNTABILITIES:

  • Primary Responsibilities include:
  • Perform testing to support Tech Ops projects following established analytical test methods in a timely manner
  • Prioritize duties to meet project expectations and deadlines; exercise judgement and ask for assistance when required
  • May assist in training other Development Associates
  • Draft studies and investigations of moderate scope and work on problems in which the analysis of the situation or data requires a review of identifiable factors. Work closely with senior level scientists to design and execute the proper studies.
  • Plays a major role in preparation of technical reports and data summaries.
  • May serve as a lead author on reports that have limited scope.
  • Maintain data integrity and perform data review activities
  • Follow SOPs and test methods to perform analytical test methods requiring precise analytical skills and understanding of biology and chemistry principles
  • Responsible for maintaining laboratory equipment, supplies, and reagents
  • Complies with the safety guidelines while performing laboratory work
  • Develop a basic understanding of monoclonal antibody cell culture and downstream purification processes
Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Bachelor s degree in a scientific discipline with a minimum of 2 yrs or MS with 0-3 years of directly related experience is required
  • Previous experience in a regulated environment highly desirable
  • Must be capable of learning, understanding, and explaining scientific rationale behind analytical methodologies utilized in this role
  • Must have demonstrated knowledge of analytical instrumentation and familiarity with one or more of the following methodologies; HPLC, ELISA, RT-PCR, SDS-PAGE, UPLC, spectroscopy, Capillary Electrophoresis
  • Comfortable in operating analytical equipment and associated software independently and in training of new analysts.
  • Well organized and detail oriented, interact cooperatively and effectively with others in a team environment, and consistently demonstrate reliability and responsibility
  • Ability to make detailed observations, perform analysis of data and interpret results with minimal guidance.
  • Ability to lead projects of limited and well defined scope.
  • Maintains familiarity with relevant scientific literature.
  • Self-motivated, developmentally oriented individual
  • Ability to communicate effectively in verbal and written form
PHYSICAL DEMANDS:
  • In general, the position requires a combination of sedentary work and walking /standing for periods of time in Manufacturing Sciences lab environment.
TRAVEL REQUIREMENTS:
  • Willingness to travel to various meetings or training, this could include overnight trips.
  • Requires approximately 5% travel.


we are driven to improve people's lives

www.takedajobs.com

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.

*LI-MJ1-USA


Schedule


Please visit our website at takedajobs.com

 
 


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