Biogen · 1 day ago
Sr Associate I, Quality Control (Small Molecule LCMS)
Biogen is a mid-sized biotechnology company committed to excellence and innovation. The Senior Associate I, Quality Control (QC) will ensure the integrity and compliance of analytical testing for drug substances and products, leading method transfers and mentoring peers while contributing to quality improvements.
BiotechnologyHealth CareNeuroscienceTherapeutics
Responsibilities
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
Qualification
Required
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
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
Benefits
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
Company
Biogen
Biogen is an American biotechnology company that provides therapeutics for neurological, autoimmune, and rare diseases.
H1B Sponsorship
Biogen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (100)
2024 (93)
2023 (101)
2022 (134)
2021 (104)
2020 (114)
Funding
Current Stage
Public CompanyTotal Funding
$1.5BKey Investors
JP Morgan
2023-08-28Post Ipo Debt· $1.5B
1991-09-27IPO
Leadership Team
Recent News
Pharmaceutical Technology
2026-01-05
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