Associate III, Quality Control Chemistry
Biogen
Summary
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.
Job description
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 Skills
- 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
Requirements
- 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
Benefits
- Medical, Dental & Vision
- Life Insurance
- Fitness & Wellness Programs
- Short- & Long-Term Disability
- Paid Vacation
- Paid Holidays
- Sick Time
- Paid Maternity & Parental Leave
- 401(k) Matching
- Employee Stock Purchase Plan
- Tuition Reimbursement
- Employee Resource Groups
Company overview
Founded in 1978, Biogen is a leading global biotechnology company headquartered in Cambridge, Massachusetts, specializing in the development and commercialization of innovative therapies for serious neurological and neurodegenerative diseases. As one of the oldest independent biotechnology companies in the United States, Biogen has established itself as a pioneer in neuroscience, focusing on difficult-to-treat conditions where few or no treatment options exist. The company's portfolio includes groundbreaking treatments for multiple sclerosis, spinal muscular atrophy, Alzheimer's disease, ALS, and Friedreich's ataxia. With approximately 7,000 employees worldwide, Biogen operates through a global network that includes research and development hubs in Cambridge, Research Triangle Park in North Carolina, and South San Francisco, along with world-class manufacturing facilities in the United States and Switzerland. The company's commitment to scientific innovation is demonstrated by its Nobel Prize-winning founders and its receipt of the U.S. National Medal of Technology and Innovation. Biogen's patient-centric approach drives its mission to deliver transformative medicines that improve lives while creating sustainable value for shareholders and communities.