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:
What you bring to Takeda:
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 Takeda can offer you:
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
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.
More about us:
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
Free vaccination program
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.Locations
AUT - Wien - Industriestrasse 67
Lexington, MAWorker Type