Job Description
The schedule for this position is M-F Business hours (full time, on-site)
About This Role
The Senior Associate I is responsible for supporting key functional, tactical, and operational aspects of the QC Microbiology department. Performs release, in-process and stability testing and all activities associated with testing. Responsibilities include, but are not limited to, training, testing support for release and stability, support for transfer, qualification/ validation activities, robust and compliant cGMP documentation practices. Adherence to all GMP requirements is required, effective interactions/ communication with Quality Control management and support of investigations is needed. The Senior Associate I should possess skills to work effectively, attention to detail, work with oversight from team/manager, within a team framework, across all business areas and levels of the organization. This position requires good written and verbal communication skills.
What You'll Do
- Provides timely review/ corrections for data and documentation generated by QC Microbiology. Initiates exceptions/ deviations as required
- Participates in basic technical problem solving and seeks guidance on resolution
- Performs sampling, in-process, release, and stability testing
- Participates in the execution of method transfer, method development, method qualification, analytical improvement projects, reagent upkeep, and validation of analytical methods in collaboration with teams as appropriate
- Supports maintenance of effective laboratory systems to ensure integrity of all laboratory results
Qualifications
Required Skills
- Bachelor's Degree in a life sciences related field
- Minimum 4 years of experience working in Quality Control in a biotech/pharmaceutical GMP environment
- Microbiology experience, including expertise in bioburden and endotoxin assays
- Method qualification experience
- Microbial identification experience
- Experience working in a drug substance and/or drug product environment
Preferred Skills
- Experience using LabWare (LIMS system)
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.