QC Microbiology/SML (Sample Management & Logistics)

Job Description

About Us:

Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. With a high level of automation and advanced processes, our state-of-the-art plant is at the forefront of modern manufacturing. Join our dynamic team to gain valuable experience in engineering and innovation.
Role Overview:

The Associate II Quality Control will be responsible for the management of QC test, stability & retain samples including GMP compliant documentation. The management means: The moving and shipping from site locations to internal and external locations with the main goal to ensure the chain of custody and according to standard work operations. Therefore, the Associate II will also need to work with a laboratory information management system (LIMS), as well with enterprise resource planning systems like Oracle. The work duties include the preparation of sample shipment documents in collaboration with trade compliance and warehouse department to ensure to be fully compliant according GMP but also legal requirements.

Qualifications

Key Responsibilities:

• Management (preparation, moving, shipping) of QC test, stability & retain samples including trade and GMP compliant documentation including support of day to day operations within the site.
• Aliquotation & sub-sampling of drug substance bags to QC samples.
• Sample Shipment: Organize and coordinate sample shipment for raw material tailgate samples, material science tailgates, manufacturing science samples, analytical development and technical development samples as well as shipment to partner organizations and CLOs.
• Support day to day operations within the Central and WIP laboratories, including management of work orders for QC related non-analytical testing equipment like freezers.
• Ordering, management and distribution of QC related reagents and consumables through all QC laboratories on site, as well as management of QC labware.
• Authoring, reviewing and approving complex GMP documentation (Plans, protocols, procedures, specifications, CAPAs, deviations etc.)

Qualifications:

• Associate’s Degree, technical degree (1-2 years) or Bachelor’s Degree
• First experience in pharmaceutical or biotech manufacturing environment. Optimally prior experience within a GMP Quality Control function related to sample management and experience with aseptical techniqes.

Preferred Skills:

• Must have basic knowledge of Microbiology and Chemistry.
• Prefered skills in buffer and solution preparation.
• First experience in aseptical working.
• Strong organization skills and ability to work autonomously.
• Good ability to communicate with all levels of management, peers, contractors and external partners effectively.
• Must have experience with typical productivity software (Word, Excel, Outlook, etc.).
• Optimally have know-how with LabWare LIMS and Oracle system.

What We Offer:

• Exposure to interdisciplinary teamwork.
• Position will work with all levels across multiple areas within the organization.

Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.