Technical Operations Manufacturing Associate II

2 weeks ago

Triangle Township, United States Biogen Full time
Job Overview

Position Summary

As a Manufacturing Specialist II within our Small Scale Manufacturing (SSM) team, you will engage in essential manufacturing support activities, including technical documentation, project oversight, and process execution. This role demands a keen attention to detail, exceptional technical writing capabilities, and a proactive approach to continuous improvement.

Key Responsibilities

  • Develop and maintain manufacturing documentation such as procedures, work instructions, logbooks, changeover protocols, batch production records, and solution lot records, ensuring alignment with stakeholder requirements with minimal supervision.
  • Lead or participate in project management and execution, ensuring timely completion of initiatives.
  • Collaborate with cross-functional teams (including Manufacturing, Manufacturing Sciences, Engineering, Automation, Quality, Planning, and Materials Management) to identify and implement continuous improvement opportunities.
  • Facilitate the technology transfer of products into manufacturing, ensuring effective communication across teams to meet production timelines.
  • Initiate and manage manufacturing-related change controls, CAPAs, and planned exceptions.
  • This role is primarily site-based, supporting manufacturing operations during standard weekday hours, with occasional off-hours support as needed.

Candidate Profile

We are looking for a detail-oriented individual with a moderate to advanced understanding of technical processes, strong technical writing skills, and expertise in manufacturing processes and equipment. This position offers the chance to collaborate and innovate with a dedicated team focused on transforming patient lives.

Qualifications

Required:

  • Bachelor's degree in Life Sciences or Engineering preferred, with at least 1 year of relevant experience.
  • Associate's Degree or Bioworks Certificate with 3 years of relevant experience.
  • High School Diploma (or Equivalent) with 5 years of relevant experience.

Preferred:

  • Experience in manufacturing, particularly in drug substance biologics, downstream or upstream operations.
  • Understanding of business processes and the roles of cross-functional teams in supporting manufacturing operations.
  • Strong knowledge of quality and cGMP principles.
  • Familiarity with change control processes in a cGMP environment.
  • Intermediate to advanced proficiency in Microsoft Office and computer-based quality systems.
  • Strong technical writing skills.
  • Ability to interpret manufacturing process design documentation.
  • Excellent verbal and written communication skills.

Why Join Biogen?

At Biogen, we are a global team dedicated to excellence and innovation. As a mid-sized biotechnology company, we offer the stability and resources of an established organization while promoting an environment where individual contributions significantly impact our mission. Our team consists of talented and passionate professionals who have unique opportunities for learning, growth, and skill enhancement. Together, we strive to deliver life-changing medicines, with every role being crucial to our success.

We are committed to fostering a culture of inclusion and belonging that reflects the diverse communities we serve. We believe that varied backgrounds, cultures, and perspectives strengthen our company and drive innovation. We focus on building teams where every employee feels empowered and inspired.

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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