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Manager, Manufacturing - Component Prep & Compounding
Manager, Manufacturing - Component Prep & CompoundingBiogen • Durham, NC, US
Manager, Manufacturing - Component Prep & Compounding

Manager, Manufacturing - Component Prep & Compounding

Biogen • Durham, NC, US
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Manager, Manufacturing (Compounding & Component Preparation)

Overview

Biogen is seeking an experienced manufacturing leader who is responsible for establishing and maintaining accountability and ownership of the Compounding & Component Preparation areas, within Biogen's Parenteral Filling manufacturing facility. Forstering a collaborative working environment throughout the manufacturing area, the Manager will be an area owner and ensure the successful execution of Biogen's manufacturing objectives.

What You'll Do

  • Provide overall leadership and management of multiple direct and indirect reports (supervisors and manufacturing associates) working in the Compounding & Component Perpetration areas, within Biogen's Parenteral Filling manufacturing facility.
  • Working closely with Supply Chain and Site Scheduling, ensure successful delivery of short and long term manufacturing schedules through proactive scheduling and planning of activities. Lead communication and remedial efforts to maintain or replan the manufacturing schedule, as required.
  • Address employee development opportunities and challenges, effectively owning and leading overall team performance. Working with the site Training team, ensure employees' training requirements are accurate and compliantly maintained.
  • Determine staffing needs and organizational structures required to efficiently meet production plans. Actively participate in hiring the best and work to develop an exceptional workforce.
  • Evaluate, develop and implement continuous improvements and best practices for the area, including safety, quality, efficiency, and capacity improvements.
  • Actively participate and contribute to technology transfers, product launches, and implementation of process changes, typically working on cross-functional teams.
  • Support cGMP compliance activities, acting as an area SME to review and approve cGMP documentation including SOPs, Batch Product Records, Change Controls, Investigations, etc.
  • Develop and track area Key Performance Indicators (KPI), including identification of lead and lag metrics. Help drive overall area performance in delivery of area KPIs.
  • Work to establish and maintain a safety focused culture. Proactively identify and remediate near-miss safety hazards.

Who You Are

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

Required Skills

  • Bachelor's Degree (BA / BS) from a four-year college or university.
  • 6+ years of direct experience in cGMP operations with a minimum of 3 years of people leadership experience within cGMP operations. Experiencing leading shop floor cGMP manufacturing teams is highly preferred.
  • Demonstrated successful experience in leading operations in cGMP environment with a focus on team development, while building a collaborative, team focused culture
  • Comprehensive understanding of relevant cGMP requirements.
  • Exception communication skills, to effectively communicate through all levels of the organization. Demonstrated ability to effectively operate within sphere of control and sphere of influence.
  • Ability to act independently, guided by broad area 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)
  • Job Level : Management

    Additional Information

    The base compensation range for this role is : $109,000.00-$146,000.00

    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
  • Short- and Long-Term Disability insurance
  • A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
  • Up to 12 company paid holidays + 3 paid days off for Personal Significance
  • 80 hours of sick time per calendar year
  • Paid Maternity and Parental Leave benefit
  • 401(k) program participation with company matched contributions
  • Employee stock purchase plan
  • Tuition reimbursement of up to $10,000 per calendar year
  • Employee Resource Groups participation
  • Why Biogen?

    We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

    At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

    All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

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