Sr Associate I, Quality Control (Drug Product)
Biogen
About This Role
As a Senior Associate I, Quality Control (QC), you will play a critical role in ensuring the integrity, accuracy, and compliance of analytical testing that supports drug substance and drug product release.
What You’ll Do
Perform and review analytical testing for product release, stability studies, and method validation.
Lead method transfer and qualification activities.
Author protocols, technical reports, and change controls.
Mentor peers and contribute to cross-functional process improvement initiatives.
Conduct impact assessments related to compliance (e.g., global directives, audit readiness, deviations).
Review and approve complex reports and data generated by others; lead complex problem-solving through facilitation and escalation when needed.
Evaluate the impact of QC activities on project teams, including implications for batch release and stability data.
Support setting and reporting of measurable goals, targets, and mitigation plans.
Represent QC during audits, inspections, and site-wide initiatives.
Who You Are
You work with a collaborative team, have the autonomy to lead initiatives, and make a measurable impact on product quality and patient safety. This role offers growth opportunities and the chance to shape the future of QC operations.
Required Skills
Bachelor’s degree from an accredited college or university (preferred STEM discipline).
Minimum of 4 years of relevant experience within Quality Control in a biotech or pharmaceutical environment.
Demonstrated expertise with LC-MS instrumentation and analysis.
Experience using acquisition/data collection systems.
Ability to manage tasks across multiple timelines and meet deadlines, including when priorities conflict.
Experience presenting information and collaborating with cross-functional or interdepartmental teams.
Strong oral and written communication skills for interdepartmental coordination.
Experience providing guidance, mentorship, or training to colleagues.
Strong knowledge of cGMP requirements and regulatory compliance standards.
Preferred Skills
Master’s degree in a STEM discipline (highly desired).
Experience with laboratory software systems such as Empower or OpenLab.
Experience with small-molecule or ASO (antisense oligonucleotide) workflows.
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 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.