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Qualification Engineer / Medical Device Biocompatibility

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Job ID R0033383 Date posted Jun. 15, 2021 Location Lexington, Massachusetts

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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 Qualification Engineer / Medical Device Biocompatibility in our Medical Device Center of Excellence (MDCoE) located at our Lexington, MA office.

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:

Qualification Engineer / Medical Device Biocompatibility will provide technical leadership in the design and execution of device and delivery system qualification testing for products (biologics, cell/gene therapy, mAb, synthetic) being developed at Takeda.  Another primary role of this position is to recommend testing and evaluation strategies to assess the biocompatibility of medical devices being developed.  The successful candidate also will collaborate with internal device development teams in the identification of user needs and the design of verification testing to assess any impact that the medical device has on drug product quality.  This individual will also interface with external contract organizations as required.

POSITION ACCOUNTABILITIES:

  • 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.

  • 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 and combination products (ISO 10993), develop biological evaluation plan, and oversee execution of the plan.

  • Manage biocompatibility testing at CROs including submission of samples, protocol review, data interpretation, and report review.

  • Author biocompatibility risk assessments in accordance with ISO 10993 and EU MDR

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

  • Ad Hoc representation on Global Device Teams as subject matter expert for device drug qualification testing

  • Author/review development documents and support regulatory submissions.

  • Support other DDQC team members on any of the above tasks as needed.

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

Technical/Functional Expertise

  • Experience with and understanding of drug delivery devices including materials used in their manufacture.

  • In-depth knowledge of biological macromolecules and pathways of degradation.

  • In-depth knowledge of material characterization including best practices for extractable/leachable testing, including pharmacopeal requirements and recommendations of key industry working groups.

  • 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 understanding of statistical techniques.

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

Leadership

  • Provides technical leadership 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.

  • Provides technical leadership in the assessment of biological safety of medical device.

Decision-making and Autonomy

  • 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 creative solutions to overcome challenges encountered during the design and execution of laboratory studies.

Complexity

  • Provide technical leadership and support on multiple projects in parallel; able to effectively balance competing priorities to meet project timelines.

EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:

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

  • At least 7 years of biopharmaceutical industry experience, preferably with medical devices.

  • Understanding of the pharmaceutical industry.

  • Demonstrates 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.

Additional Information

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

TRAVEL REQUIREMENTS:

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

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

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please

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*This job posting excludes CO applicants*

EEO Verbiage for US Reqs

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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