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
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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 Biogen.
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.
