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Senior Standards and Reagent Specialist (f/m/x)

Lexington, MA
Start date
Sep 22, 2023

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Clinical, Clinical Medicine
Required Education
Bachelors Degree
Position Type
Full time
Genetown, Best Places to Work

Job Details

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

About the role:

As a Senior Standards and Reagent Specialist you will be tasked notably with the S&R specification design as well as the qualification coordination and the inventory control.

How you will contribute:
  • Life Cycle Management: Design S&R specifications and ensure compliance to applicable internal and external GMP regulations, lead and coordinate respective activities.

  • Product Quality: Coordinate qualification activities and provide regulatory support for reference standards and related aspects, which includes providing submission content strategy, analytical content authoring and review as needed.

  • Inventory Control: Ensure undisrupted, timely supply and distribution of standards and reagents for and between internal Takeda laboratories and CMOs, CTLs.

  • Capability building: Mentor team members to resolve complex problems and provide training to colleagues globally in all aspects of S&R management.

  • Trouble Shooting: Provide guidance regarding complex issues to QC labs and manufacturing sites by supporting or leading investigations and technical problem-solving activities.

  • Actively contribute to the preparation of internal audits and regulatory inspections (on-site).

  • Consider all relevant aspects and understanding the impact and ramifications to needs of patients, GMP regulations, supply chain and the business.

  • Transfers: Organize and drive S&R transfer processes into and from Global S&R.

What you bring to Takeda:
  • A (higher) technical/life science degree is typically required (may be substituted by experience or previous on the job training)

  • A minimum of 3 years of experience in the pharmaceutical industry (preferably quality role) is required

  • Experience with standards & reagents related processes is requirement, hands on experience in management, qualification or manufacturing of standards & reagents is a plus

  • Experience in managing global quality systems is desired

  • Excellent communication, interpersonal and organizational skills

  • Ability to work well both independently and in a team environment

  • Ability to prioritize work and drive multiple workstreams

  • Conducts work in compliance with cGMPs, safety and regulatory requirements

What Takeda can offer you:

A competitive remuneration package with a minimum salary of € 3.909,67 gross per month (full-time, collective wage agreement for the chemical industry) - the actual salary depends on your professional experience and qualifications.

  • Family-friendly company environment; Support with parental leave, dad month, Bilingual company kindergarten

  • Work @ home depending on the position / department

  • Comprehensive training programs

  • In-house job rotation program

  • In-house Canteen with discounts or meal vouchers

  • Works council (events, festivals, shopping vouchers, etc.)

  • Employee Referral Program

  • Employee Recognition Program

  • Takeda Resource Groups

  • Medical checkups

  • Free vaccination program

  • Fitness Center

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

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, or any other characteristic protected by law.


AUT - Wien - Industriestrasse 67

Lexington, MA

Worker Type


Worker Sub-Type


Time Type

Full time


Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions.

For more information, visit

Stock Symbol: TAK

Company info
650 East Kendall Street
United States

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