Biogen Idec

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QC Manager, Bioassay

at Biogen Idec

Posted: 8/1/2019
Job Reference #: 836910

Job Description

US-NC-Research Triangle Park

Job Description
The QC Manager, Bioassay will be responsible for scheduling/balancing of team workload with respect to assignments, responsibilities, personnel, management of departmental milestones. In addition they will be accountable for approval of technical documents for QC team; maintaining tracking of workload and processes for team to ensure optimization and delivery; ensuring GMP compliance, and alignment with quality systems.

Principle Accountabilities include:
1.Oversees team deliverables and sustainability with timely communication for priorities. Properly escalates issues to senior QC management as applicable to impact for teams. Tracks & reports progress to tasks and departmental metrics to upper management, as applicable.
2.Able to flex and respond to unexpected situations, demands. Effectively problem solve and reallocate resources as necessary. Provides leadership for QC initiatives as related to scientific, technical discipline, business strategy- global improvements.
3.Leads more complex projects, initiatives. Manages activities including; technical writing, project representation that are complex and/or those with significant impact (routine or minimal complexity).
4.Hires and develops a well-functioning team – focusing on values and culture, diversity and inclusion. Ensures establishment of goals and development plans for employees. Ensures effective team training for group activities, responsibilities and performs performance reviews.
5.Coordinates activities with other departments; provides updates to QC team management. Routinely works closely with Quality Assurance, PQM, Regulatory, TD, Validation, AT, cross site stakeholders etc.


Requisition Number

Employment Category
Full-Time Regular

External Posting Title
QC Manager, Bioassay

Job Category

•7+ years in GMP laboratory role/support role
•4+ years leadership experience in comparable role, experience with regulations, FDA/MHRA
•3+ Years of experience working with Bioassays
•Ability to effectively lead change & complete initiatives aligned with business.
•Ability to provide input to the development of strategy, policy, group objectives and with business partners.
•Ability to drive team understanding and ensure incorporation of industry, best practices, quality directives and regulatory requirements.
•Established effective leadership within an organization.
oLeadership competencies include Personal drive, Innovation, Developing others, Decision making, Communications, Building strategic work relationships.

Bachelor’s degree (B.S.) in science or Master’s degree (M.S.)

Experience Level
Mid-Senior Level

Oversees the responsibilities of the RTP DS QC Bioassay Lab; develops team members and career paths; implements best industry practices; leads and participates in projects; participates in cross-site teams. Ensures team is aligned with goals, objectives. Conducts performance evaluations for subordinates and ensure that employees are trained.