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Scientist at Takeda Development Center Americas, Inc.

Posted in General Business 30+ days ago.

Type: Full-Time
Location: Lexington, Massachusetts





Job Description:

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Scientist, Medical Devices, Device Drug Qualification & Compatibility in our Medical Devices Center of Excellence (MDCoE) located at our Lexington, MA campus.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission.

POSITION OBJECTIVES:

As part of the Medical Device's DDQC group, this position will support study design and laboratory activities related to the in-use qualification/compatibility testing of biologic/device combination products and stand-alone medical devices being developed within Takeda's pipeline and commercial product portfolios. Additionally, this position will support the biological evaluation (biocompatibility) of Takeda's devices as part of their overall safety assessment.

POSITION ACCOUNTABILITIES:

The successful candidate will collaborate with a team of scientist within DDQC and other internal medical device development engineering teams to assist in the identification of user needs and the design of verification and validation testing to further assess any impact of our devices on Takeda's drug products.

This individual will execute feasibility, material compatibility, and in-use qualification testing as part of this role and would be exposed to a range of life cycle development activities for Takeda's medical devices including early feasibility studies as well as commercial investigations.


  • Assist in the design and execute phase appropriate studies to assess compatibility and in-use stability of Takeda's pipeline products with devices being developed at Medical Devices Center of Excellence.


  • Assist in the design and execute studies to qualify the use of off-the-shelf devices with Takeda's global product portfolio as needed for geographical expansions.


  • Recommend testing and evaluation strategies to assess biological safety risks of Takeda's medical devices, develop biological evaluation plan, and oversee execution of the plan.


  • Author/review development technical documents including data generation, review, and documentation.


  • Support departmental (or cross functional) key initiatives focused on continuous improvement, innovation, and/or enhancing technical capabilities.


EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:

Education:


  • MS degree required with discipline in science (chemistry, biology, biochemistry).


  • At least 3 years of biopharmaceutical industry experience, preferably within analytical or drug product development and/or medical devices.


  • Understanding of the pharmaceutical industry preferred.


  • Demonstrates the ability to work collaboratively across functions, regions, and cultures.


  • Must be self-motivated, take initiative, and be a team player.


  • Excellent communicator, able to critically evaluate results and convey data succinctly and effectively, both verbally and in writing.


  • Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors within the organization.


  • Able to work independently to deliver on project milestones while ensuring management is engaged and aware of progress and activities.


  • Must possess an eagerness to learn and grow as well as invest time in helping others to enhance their skills and perform at a higher level.


Technical:

  • Extensive benchwork skills in a "wet-lab environment" is necessary and knowledge of biological macromolecules is desired.


  • Hands on experience with common analytical techniques including HPLC, spectrometry (UV, IR), microscopy, flow imaging technology, and other particle size analysis techniques.


  • In-depth knowledge of biocompatibility related standards and regulatory guidance, such as ISO/AAMI 10993, MDR, USP, EP and FDA Guidance for Use of ISO 10993-1.


  • Sound knowledge of current Good Manufacturing Practices (cGMP).


  • Strong organizational skills and good documentation practices are a must.



Technical/Functional (Line) Expertise

This position is an advanced level wet bench position and requires strong hands-on laboratory skills and understanding of experimental design and study execution.

Leadership


  • Provides technical guidance in the design and execution of device and delivery system qualification testing for products (biologics, cell/gene therapy, mAb, synthetic) being developed in R&D.


  • Leads laboratory initiatives and general lab function.


  • Leads gap assessments/remediation efforts related to biocompatibility testing as part of product life cycle and changes to global industry standards.


Decision-making and Autonomy

  • Strong decision-making skills would be needed for this position, and the ideal candidate will work closely with a small group of scientists.


  • Promotes visibility and transparency of information within our function and department.


Interaction

  • Builds strong relationships and collaborates effectively with internal (Development Device Engineering, Commercial Device Engineering, Clinical Development) and external functions (Device Quality, Biologics Drug Product Development, Quality Control) of MDCoE.


  • Cultivates a broad network of relationships throughout Takeda and with external partners (CROs, CMOs, vendors) in the industry.


Innovation
  • Finds solutions to overcome challenges encountered during the design and execution of laboratory studies through experience and literature searches.

  • Participate with others within the MDCoE to advance new and exciting technologies.

Complexity
  • Ability to support multiple programs and key initiatives while being able to generate critical data for program decisions in a timely fashion.


Additional Information

  • This position may require up to 60% of the time in the laboratory on site.


  • Willingness to occasionally travel to various meetings, CROs, and other Takeda sites is desired.



TRAVEL REQUIREMENTS:
  • Willingness to occasionally travel to various meetings, CROs, and other Takeda sites.


Updated Takeda U.S. Vaccine Requirement:

Effective November 1, 2021, absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. As of the same date, absent an approved religious or medical reason, US field-based employees, employees must be fully vaccinated in order to continue in their current roles. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. Candidates are encouraged to speak with their recruiter to seek further information on the applicable guidelines for the Business Unit/Function for which they have applied.

This job posting exclude Colorado applicants.

WHAT TAKEDA CAN OFFER YOU:


  • 401(k) with company match and Annual Retirement Contribution Plan


  • Tuition reimbursement


  • Company match of charitable contributions


  • Health & Wellness programs including onsite flu shots and health screenings


  • Generous time off for vacation and the option to purchase additional vacation days


  • Community Outreach Programs



Empowering Our People to Shine

Discover more at takedajobs.com

No Phone Calls or Recruiters Please.

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EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





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