Sr. Associate I, Quality Control Raw Materials
Biogen
Summary
The Senior Associate I, Quality Control Raw Materials ensures raw materials meet quality and compliance standards through laboratory testing, sampling, investigations, and quality system support. This role partners with cross-functional teams to maintain GMP compliance, support manufacturing, and drive product quality.
Job description
About This Role
The Senior Associate I, Quality Control Raw Materials ensures raw materials meet quality and compliance standards through laboratory testing, sampling, investigations, and quality system support. This role partners with cross-functional teams to maintain GMP compliance, support manufacturing, and drive product quality.
What You'll Do
- Perform raw material sampling and testing
- Execute compendial and non-compendial analytical testing methods (particularly GC and LC/MS)
- Conduct method validations, qualifications, and laboratory studies
- Author investigation reports, protocols, change controls, and technical documents
- Support investigations, CAPAs, and quality system activities
- Review analytical data and documentation for accuracy and compliance
- Troubleshoot laboratory methods, instrumentation, and testing issues
- Partner with Manufacturing, Quality, and cross-functional stakeholders
- Support process validation and continuous improvement initiatives
- Mentor junior team members and provide technical guidance
- Other duties as assigned
Who You Are
You are a collaborative laboratory professional who thrives in a GMP-regulated environment and enjoys solving complex technical challenges. You combine strong scientific expertise with excellent organizational skills and can effectively balance multiple priorities while maintaining a high standard of quality and compliance.
Required Skills
- Bachelor's degree (preferred in science related field) plus minimum 2-4 years of GMP pharma or biotech industry experience within QC (or Associate's degree plus minimum 4 years or Master's degree with minimum 1 year)
- Raw material and compendial testing experience
- GC analytical testing
- Method validation and qualification
- Technical report writing
- Data integrity and documentation review
- Scientific troubleshooting and problem solving
Preferred Skills
- LC/MS analytical techniques highly desired
- Experience with HPLC testing
- Leadership or mentoring experience
Requirements
- Bachelor's degree (preferred in science related field) plus minimum 2-4 years of GMP pharma or biotech industry experience within QC (or Associate's degree plus minimum 4 years or Master's degree with minimum 1 year)
- Raw material and compendial testing experience
- GC analytical testing
- Method validation and qualification
- Technical report writing
- Data integrity and documentation review
- Scientific troubleshooting and problem solving
- LC/MS analytical techniques highly desired
- Experience with HPLC testing
- Leadership or mentoring experience
Benefits
- Medical, Dental & Vision
- Life Insurance
- Fitness & Wellness Programs
- Short- & Long-Term Disability
- Paid Vacation
- End-of-Year Shutdown
- Paid Holidays
- Sick Time
- Paid Maternity & Parental Leave
- 401(k) Matching
- Employee Stock Purchase Plan
- Tuition Reimbursement
- Employee Resource Groups
Company overview
Founded in 1978, Biogen is a leading global biotechnology company headquartered in Cambridge, Massachusetts, specializing in the development and commercialization of innovative therapies for serious neurological and neurodegenerative diseases. As one of the oldest independent biotechnology companies in the United States, Biogen has established itself as a pioneer in neuroscience, focusing on difficult-to-treat conditions where few or no treatment options exist. The company's portfolio includes groundbreaking treatments for multiple sclerosis, spinal muscular atrophy, Alzheimer's disease, ALS, and Friedreich's ataxia. With approximately 7,000 employees worldwide, Biogen operates through a global network that includes research and development hubs in Cambridge, Research Triangle Park in North Carolina, and South San Francisco, along with world-class manufacturing facilities in the United States and Switzerland. The company's commitment to scientific innovation is demonstrated by its Nobel Prize-winning founders and its receipt of the U.S. National Medal of Technology and Innovation. Biogen's patient-centric approach drives its mission to deliver transformative medicines that improve lives while creating sustainable value for shareholders and communities.