Associate III, Quality Control Chemistry

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.

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.

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