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 Systems
- Oversight of Microbial Identification Program
- Support Manufacturing Batch Production (Manufacturing Deviations, Summary Reports)
- Data review for lab generated results
- Maintain 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 field
- Minimum 7-10 years of experience working in Quality Control in a biotech/pharmaceutical GMP environment
- Microbiology experience, including expertise in bioburden and endotoxin assays
- Demonstrated project management skills
- Method qualification experience
- Microbial identification experience
- Experience working in a drug substance and/or drug product environment
- Strong verbal and written communication skills
Preferred Skills
- Experience using LabWare (LIMS system)
- TrackWise experience
- PLM 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.
Top Skills
What We Do
Through cutting-edge science and medicine, Biogen discovers, develops and delivers innovative therapies worldwide for people living with serious neurological and neurodegenerative diseases.
Founded in 1978, Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics.
With approximately 7000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.
For more information, please visit www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.
