Manufacturing Operations Specialist II

1 week 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 play a crucial role in supporting manufacturing operations. Your responsibilities will encompass technical documentation, project oversight, and process enhancement. 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 expectations with minimal supervision.
  • Lead or contribute to project management initiatives, ensuring timely execution and successful outcomes.
  • Collaborate with various departments (e.g., Manufacturing, Engineering, Quality, and Materials Management) to identify and implement continuous improvement strategies.
  • Facilitate the transfer of technology for 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 operates during standard business hours but may occasionally require after-hours support.

Candidate Profile

If you are a detail-oriented individual with a solid understanding of technical processes, technical writing expertise, and manufacturing knowledge, you will thrive in our Manufacturing Technical Operations Team. This position offers a unique opportunity to collaborate with a dedicated group focused on improving patient outcomes.

Qualifications

Required Skills:

  • 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 Skills:

  • Experience in manufacturing, particularly in drug substance biologics, downstream or upstream operations.
  • Familiarity with business processes and the roles of cross-functional teams in manufacturing.
  • Strong understanding of quality and cGMP principles.
  • Knowledge of change control processes in a cGMP environment.
  • Intermediate to advanced proficiency in Microsoft Office and quality management 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 committed to excellence and innovation. As a mid-sized biotechnology firm, we offer the stability of an established organization while fostering an environment that values individual contributions. Our team is composed of talented professionals dedicated to delivering transformative medicines, with every role playing a vital part in our mission. We prioritize a culture of inclusion and belonging, recognizing that diverse perspectives enhance our innovation and effectiveness.

We welcome all qualified applicants and are committed to a workplace free from discrimination. Biogen is an E-Verify Employer in the United States.

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