Job Description

The schedule for this position is M-F Business hours (full time, on-site)

About This Role  

The candidate will be required to coordinate within and across teams to support batch production and release, technical transfers and validation. This role will be responsible for leading multi-faceted projects and oversight of laboratory systems. This person will report to the QC manager and will work in a team with approximately eight individuals.

What You’ll Do  

Oversight and support for the Laboratory Investigation systems (Deviations, I/A’s, A/A’s)Oversight of Change Control and Other Compliance SystemsOversight of Microbial Identification ProgramSupport Manufacturing Batch Production (Manufacturing Deviations, Summary Reports)Data review for lab generated resultsMaintain the laboratory in an audit ready state

Who You Are

You enjoy working with complex systems and within and across teams. You are independent with the ability to handle multiple projects and able to drive actions towards completion.

Qualifications

Required Skills  

Bachelor’s Degree in a life sciences related fieldMinimum 7-10 years of experience working in Quality Control in a biotech/pharmaceutical GMP environmentMicrobiology experience, including expertise in bioburden and endotoxin assaysDemonstrated project management skillsMethod qualification experienceMicrobial identification experienceExperience working in a drug substance and/or drug product environmentStrong verbal and written communication skills

Preferred Skills 

Experience using LabWare (LIMS system)TrackWise experiencePLM experience

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.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.