Senior Manager, Manufacturing (Parenteral Filling)

Job Description

About This Role

Biogen is seeking an experienced leader that will report to the Head of Parenteral Operations and be responsible for establishing and maintaining accountability and ownership of Parenteral Filling operations. This individual will communicate manufacturing management goals and provide visibility for all levels of the staff. In addition, they will focus on regulatory compliance as well as exhibit overall leadership for manufacturing operations supporting the site.

What You’ll Do
  • Provide overall direction, coordination and evaluation of multiple direct reports and indirect reports for a Parenteral Filling Facility that will operate with multiple shifts.
  • Drive major projects and programs for Organizational Unit or Function to completion within schedule and budget
  • Conduct briefings and participates in technical meetings for senior management concerning specific operations
  • Key member of cross functional integrated working team
  • Manage process changes to support overall cGMP compliance
  • Review state of operations from fiscal overview to area walk-throughs
  • Identify and report potential operational risks and issues to senior management and lateral operational managers
  • Represent technical operations for inter-site and inter-departmental meetings.
  • Review HR issues and staffing concerns in order to best support team progress and effectiveness
  • Support team members as they focus on personal and team development

Who You Are

You are a collaborative leader with technical experience in cGMP Parental Filling. You enjoy problem solving, continuous improvement and team development.

Qualifications

Required Skills
  • Bachelor’s Degree (BA/BS) from a four-year college or university with an emphasis in Biotech and/or Engineering.
  • 10 years’ of direct relevant experience
    • Experience in cGMP Parenteral filling with Isolators (vial filing preferred broad exposure to final container closures is ideal)
    • Experience with visual inspection systems, both manual and automated
  • Demonstrated ability to lead and develop teams
  • FDA / EMA Inspection experience inclusive plant tours and inspection room SME function
  • Comprehensive understanding of relevant industry issues.
  • Strong and broad communication skills, written, verbal and human / human interactions
  • Ability to act independently, guided by broad company policies and objectives.
  • Ability to analyze complex problems and find common ground outcomes
  • Availability to address urgent issues outside of typical work hours (i.e. weekends, holidays and non-scheduled work-days)




Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.

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