Sr Associate I, Quality Control (Drug Product)

Biogen Idec•Research Triangle Park, NC

26d•$79,000 - $103,000

About The Position

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. 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.

Requirements

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.

Nice To Haves

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.

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.

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