Posted to MedZilla on 5/24/2017


Takeda Pharmaceuticals

US-MA, Quality Control Manager 1701311-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:

  • Responsible for leading and managing complex projects of diverse scope within QC and cross-functionally.
  • Independently manages Small Molecules/Oral Solid Dosage analytical test methods and provide guidance in the area of expertise for release and stability testing of commercial pharmaceutical products.
  • Writes analytical sections and response to questions to support test methods and regulatory filing.
  • Provides and supervises analytical investigations.
  • Writes, reviews and executes method transfer protocols.
  • Uses judgment and experience in method troubleshooting, improvements and implementation activities.
  • Support method validation activities within and outside Takeda.
  • Review experimental data generated internally and/or externally.
  • Write, review and/or revise controlled documents when necessary.
  • Leads training and on-boarding activities for new employees.
  • Manages Lab software maintenance and update including Empower, SDMS and ELVAN.
  • Represents QC business processes and needs within the department and at cross functional forums as a technical expert.

ACCOUNTABILITIES:

  • Demonstrates functional versatility and performs work on complex problems of broad scope that encompass multifaceted project and methodological areas.
  • Recognizes as an Analytical expert in Oral Solid Dosage for assay optimization, validation and transfer.
  • Present analytical issues and findings to senior management
  • Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
  • Proactively participate in the planning and prioritization of lab operations and/or the resolution of quality and compliance issues.
  • Participate in software/equipment qualification.
  • Applies scientific judgment to perform investigations of Out of Spec (OOS) and Atypical results.
  • Initiates / works with external service providers on the timely resolution of deviations, CAPAs and change controls within the electronic Quality Management System.
  • Independently revise and author new SOPs and study documentations
  • Provides mentoring, training and may serve as Lab Lead to direct work of QC Analysts.
  • Leads projects and coordinates projects with internal and contract sites
Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:


Bachelor s Degree in any Life Sciences with relevant laboratory coursework and 8+ years of relevant experience or Master s Degree in any Life Sciences with relevant laboratory coursework and 6+ years of relevant experience.
  • Experience directing activities related to analytical method development, qualification and validation of Small Molecules, Oral Solid Dosage assays, method performance monitoring, methods transfer and working with external laboratories
  • Experience with regulatory writing of analytical sections and response to questions
  • Excellent communicator, author and creative thinker with extensive knowledge in the area of expertise
  • Specific techniques include HPLC, UPLC, LC-MS, GC, NMR, particle size, XRPD, Dissolution and Disintegration, ICH Q3D implementation, ICP-MS, KF and compendia methods
  • Excellent project and people manager who can motivate, direct projects, and align scientific
  • A strong collaborator who can manage interdependencies with other business groups within and outside of Takeda
  • Must display eagerness to learn and continuously improve.
  • Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.

PHYSICAL DEMANDS:

  • In general, the position requires a combination of sedentary work and standing for extended periods of time in the Quality Control labs.
TRAVEL REQUIREMENTS:
  • Willingness to travel to various meetings or training, this could include overnight trips.
  • Requires approximately 10% 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-DB-USA1


Schedule


Please visit our website at takedajobs.com

 
 


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  considered, please do so. Applications for all positions are subject to each employer's specific requirements.