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Production Support Specialist II

2 months ago

Triangle Township, United States Biogen Full time
Job Overview

Position Summary

As a Manufacturing Specialist II within the Small Scale Manufacturing (SSM) team, you will play a pivotal role in supporting manufacturing operations. Your responsibilities will encompass technical documentation, project coordination, and process optimization. This role demands a keen attention to detail, strong technical writing capabilities, and a proactive approach to continuous improvement.

Key Responsibilities

  • Develop and maintain comprehensive manufacturing documentation, including procedures, work instructions, logbooks, changeover protocols, batch production records, and solution lot records, ensuring alignment with stakeholder expectations under minimal supervision.
  • Lead or contribute to project management initiatives, ensuring timely execution and effective collaboration.
  • Collaborate with cross-functional teams (such as Manufacturing, Manufacturing Sciences, Engineering, Automation, Quality, Planning, and Materials Management) to identify and implement continuous improvement strategies.
  • 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 primarily supports manufacturing operations during standard weekday hours, with occasional off-hours support as needed.

Candidate Profile

We are seeking a detail-oriented individual with a solid understanding of technical processes, exceptional technical writing skills, and expertise in manufacturing processes and equipment. This position offers an opportunity to collaborate 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, with knowledge of downstream or upstream operations.
  • Familiarity with business processes and the roles of cross-functional teams in manufacturing.
  • Strong understanding of quality principles and cGMP regulations.
  • Knowledge of change control processes in a cGMP environment.
  • Proficient in Microsoft Office and computer-based quality systems.
  • Intermediate to advanced technical writing skills.
  • Able to interpret manufacturing process design documentation.
  • Excellent verbal and written communication abilities.

Why Join Biogen?

At Biogen, we are dedicated to excellence and innovation. As a mid-sized biotechnology company, we offer the stability of an established organization while encouraging individual contributions that make a significant impact. Our team consists of talented professionals who are passionate about learning, growth, and skill development. Together, we strive to deliver life-changing therapies, with every role contributing to our mission.

We are committed to fostering a culture of inclusion and belonging that reflects the diverse communities we serve. We believe that diverse backgrounds and perspectives enhance our innovation and effectiveness. We are focused on building teams where every employee feels valued 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 law. Biogen is an E-Verify Employer in the United States.