Scientist I, Quality Control (Quality Support) at Biogen in Research Triangle Park, North Carolina

Job Description:

Job Description

This position is a hybrid role and will report on site to our RTP location minimum of 3 days per week (subject to change based on business needs)

About This Role  

A Scientist I in the quality control (QC) reference standards and qualified materials (RSQM) team is responsible leading key functional, tactical, strategic aspects for RSQM activities and issues associated with small molecule (SM), antisense oligonucleotides (ASO), or biological programs. This individual manages multiple programs/projects within RSQM and drives initiatives related to the technical and strategic aspects while working independently. The Scientist I performs QC activities associated with overall RSQM philosophy including inventory, shipping, sourcing new materials, qualification of materials, extension of materials, exceptions, and review of documents. They are responsible for preparing & approving technical protocols/reports pertaining to use of RSQMs, and ensures all work is carried out in a cGMP manner, with adherence to regulatory expectations. 

What You'll Do  

• Act as a program manager/project lead for multiple programs/projects within RSQM and drive initiatives for RS or qualified material activities (technical, tactical, strategic) independently


• Author, review, and approve controlled GMP documents, protocols and reports, change control requests, risk assessment, regulatory documents required to support QC business & compliance & methodology


• Participate or lead continuous improvements projects


• Solve technical issues related to RSQM materials


• Participate as an effective member of cross-functional teams as a representative of the QC RSQM. 


• Apply holistic quality system approach through identifying and solving technical issues and identifying areas for improvement or remediation related to quality


• Other duties as assigned

Qualifications

• Bachelor's degree plus 5 years of relevant experience OR Master's degree plus 2 years of relevant experience OR PhD in a chemistry, biotech or pharmaceutical field


• Experience working in GMP manufacturing/biotech/pharma environment


• In-depth knowledge of QC analytical assays for SMs, ASOs, or Biologics


• Knowledge of reference standards, validation strategies, regulatory filings, QC and analytical laboratory operations 


• Excellent technical writing/presentation skills as well as authoring and approval of complex reports


• Skilled in conducting impact assessment related to compliance, understanding/assigning risk and prioritization


• Leadership competencies include follow up, decision making, communication, collaboration, innovation & building strategic networks

Preferred Skills

• Data analysis skills

Additional Information

The base salary range for this position is $91,000 - 118,000 annually. 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.

 

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