Biogen Idec

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Senior Manager, Analytical Technology (Small Molecules and Antisense Oligonucleotides)

at Biogen Idec

Posted: 9/22/2019
Job Reference #: 834264
Keywords: manager

Job Description

Location
US-NC-Research Triangle Park

Job Description
The Senior Manager reports into the Associate Director and interfaces with cross-functional leaders within Technical Development, Quality Control, Regulatory and Manufacturing teams to ensure program milestones are met. The senior manager will lead a team of direct reports and develop strategies for adoption of new technologies, analytical testing for drug substance/drug product release and stability, and engagement with regulatory authorities through NDA filings and agency meetings.

Responsibilities include:
•Manage and develop a team of scientists responsible for method improvements/optimization, validation and transfer, and the evaluation/implementation of new technologies for a GMP QC environment.
•Ensure best practices in accordance with associated regulations and guidance documents for industry on analytical methods and testing strategies.
•Accountable for ensuring budget, resources and appropriate timelines to achieve key program milestones for clinical through commercial life cycle management.
•Develop project management tracking tools for communication to senior leadership team and stakeholders.
•Develop creative solutions to complex problems while ensuring compliance and quality for GMP.
•Present at relevant conferences and publish in peer-reviewed journals.
•Drive innovation, propose and implement new strategies, develop efficiency in processes.
•Assure robust and compliant methods for GMP testing.
•Create flexibility within a regulated environment for life cycle management of approved products.

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Requisition Number
38285BR

Employment Category
Full-Time Regular

External Posting Title
Senior Manager, Analytical Technology (Small Molecules and Antisense Oligonucleotides)

Job Category
Quality, Regulatory, Research & Development, Technical Development

Qualifications
•Skilled manager effective in recruiting, developing and retaining talent
•Proven leader with the ability to influence others
•In-depth technical understanding of analytical methods associated with in-process, release and stability testing of small molecules or ASOs including LC-MS, UPLC, HPLC, GC, KF, Dissolution, and FTIR
•Applied knowledge of GMP regulatory guidance on method validation, transfer, compendial method verification, compendial compliance, design of experiments, statistical data analysis
•Excellent presentation skills, ability to share technical content to a diverse audience
•Strong technical writer and reviewer

Education
•PhD in Chemistry +6 years in industry
•Or equivalent combination of education and experience will also be highly considered

Experience Level
Mid-Senior Level

Summary
This key position in the leadership team oversees the Analytical Technology (AT) group responsible for the evaluation and implementation of new analytical technologies, validation/transfer of analytical methods, and troubleshooting method-related issues for the Quality Control (QC) labs.