Associate III, Quality Control Chemistry

Biogen; North Carolina; On-site; USD 69,000 - 90,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) with company match

Tuition reimbursement

Job summary

Biogen is seeking a Quality Control Associate III to support the QC Chemistry department in maintaining cGMP compliance and to drive completion of departmental milestones for clinical and commercial product testing. The role involves release/stability testing, investigations, and coordinating test results with chemistry customers to support site and global initiatives.

The successful candidate will perform release and stability testing, write/ review protocols and validation documents, and

Qualifications

• Bachelor’s degree or Associate degree (+2 years lab experience) in biological/chemistry/life sciences
• HPLC experience required
• Knowledge of QC Chemistry release and stability methodology
• Experience with FDA/EMEA regulations and compliance
• Proven instrument/method troubleshooting skills
• Demonstrated problem solving skills

Responsibilities

• Performs release and stability testing and reviews data.
• Authors or reviews investigational protocols and validation reports.
• Supports transfer, qualification, method development, and validation projects.
• Provides technical leadership through project management and investigations.
• Maintains laboratory systems to ensure data integrity.
• Participates in cross-functional site teams and mentors peers.

Skills

HPLC experience

Instrument/method troubleshooting

Quality Control knowledge

FDA/EMEA regulations knowledge

Problem solving

Multi-tasking

Communication skills

GMP experience

Education

Bachelor’s or Associate degree in biological/chemistry/life sciences

Job description

Job Description

The Quality Control Associate III will support the management team to ensure that laboratory and Quality systems within the QC Chemistry department remain in compliance with Biogen Idec and industry cGMP standards. Additionally, the Associate III will actively support the completion of all departmental milestones associated with clinical and commercial product manufacture and testing. The Quality Control Associate III has frequent interaction with the Supervisor, Manager and Associate Director of QC Chemistry as well as peers (Associate I, II, III) with the purpose of performing release/stability testing, leading investigations, discussions pertaining to strategic initiatives, personnel development, and testing-related issues. Importantly, the Associate III is responsible for generating, communicating, and coordinating test results with key Chemistry customers, as appropriate, to support departmental, site, and global initiatives. Finally, the Associate III will have cross-departmental interaction with peers to ensure timely communication of issues to support QC and manufacturing initiatives.

What You'll Do

• Performs release and stability testing, as needed. Performs sound technical review for data and documentation generated for or by QC Chemistry
• Authors or reviews investigational protocols, investigational reports, change control requests, validation protocols, and validation reports, etc.
• Supports the execution of the transfer, qualification, method development, analytical improvement projects, and validation of analytical methods in collaboration with the Analytical Technology/Development group
• Provides technical leadership through effective project management including laboratory investigations
• Support maintenance of laboratory systems to ensure data integrity
• Participates effectively in a leadership or membership role for site cross-functional teams as a representative of the QC Chemistry laboratory
• Actively provides leadership and mentoring as needed to aide in the development of their peers

Who You Are

You are task driven, focused and/or willing to learn. You are a collaborative person capable of being both agile and customer focused.

Required Skills

• Bachelor's degree or Associate's degree (+2 years lab experience) in biological/chemistry/life sciences
• HPLC experience
• Possess technical knowledge regarding Quality Control Chemistry release and stability methodology
• Demonstrated instrument/method troubleshooting skills
• Knowledge of FDA/EMEA regulations and compliance

Preferred Skill s

• Prior GMP experience in industry, especially in QC Chemistry
• LC MS, HPLC, Dissolution, Karl Fischer, GC experience
• Previous work with small molecule or antisense oligonucleotides
• Solid presentation, oral and written communication skills
• Ability to communicate with peers and management
• Effective organizational skills
• Ability to multi-task and coordinate multiple activities in parallel
• Demonstrated problem solving skills

Job Level: Professional

Additional Information

The base compensation range for this role is: $69,000.00-$90,000.00

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. Ch