Sr. Manufacturing Specialist I

Biogen; North Carolina; On-site; USD 85,000 - 115,000; Full time

Job summary

Biogen in North Carolina is seeking a Sr. Manufacturing Specialist I to support ASO, OSD, and L&P teams with manufacturing readiness, process implementation, and technical writing during technology transfer and startup activities.

The role requires detail orientation, strong technical writing, and project-management skills, with weekday core hours and occasional off-hours support as needed to ensure successful product transfers and regulatory-compliant documentation.

Qualifications

• Bachelor's degree required; direct experience may substitute.
• 3+ years in biotech/pharma or adjacent field.
• Experience in biopharmaceutical environments with cGMP knowledge.
• Experience authoring, reviewing, and maintaining technical documentation.
• Intermediate to advanced Microsoft Office and quality systems experience.
• Experience in Continuous Improvement, Operational Excellence, Manufacturing Excellence, or Process Improvement programs.

Responsibilities

• Lead site readiness plans for product transfer and process technology.
• Coordinate change controls, documentation readiness, and training readiness.
• Lead readiness reviews, governance meetings, and stakeholder communications.
• Identify readiness gaps and escalate issues as needed.
• Lead complex cross-functional projects supporting technology transfer and manufacturing improvements.
• Author and maintain manufacturing documentation with a high degree of accuracy and compliance.

Skills

Root cause analysis

Technical documentation

Microsoft Office

Continuous improvement

Project management

Education

Bachelor's degree in biotech/pharma or related field

Job description

About This Role

In this Sr. Manufacturing Specialist I role, you will be responsible for manufacturing support tasks including technical writing, project management, and process implementation in our ASO (Antisense Oligonucleotide), OSD (Oral Solid Dose) and L&P (Label and Pack) teams. This position requires you to be highly detail oriented with excellent technical writing skills and a continuous improvement mindset.

Shift Details: Monday-Friday from 8 AM - 5 PM, standard business hours.

This site-based role supports MFG, primarily during core weekday business hours, but may require infrequent off-hours support.

What You'll Do

• Serve as the primary receiving‑site operational readiness lead for new product and process technology transfer programs.
• Develop, maintain, and drive integrated site readiness plans that align manufacturing startup activities across multiple functions.
• Lead readiness reviews, governance meetings, action tracking, and stakeholder communications to ensure successful execution.
• Identify readiness gaps and proactively escalat
• Coordinate critical readiness activities including:
  • Change Controls
  • Material Readiness
  • Equipment Qualification Support
  • Manufacturing Documentation Readiness
  • Training Readiness
  • Floor Support Planning
  • Analytical Readiness
  • Changeover Readiness
• Lead complex cross-functional projects supporting technology transfer, operational readiness, manufacturing improvements, and manufacturing execution while managing timelines, risks, and stakeholder expectations.
• Author and maintain manufacturing documentation including procedures, work instructions, logbooks, changeover protocols, batch production records, solution lot records, investigations, and technical reports with a high degree of accuracy and compliance.
• High level Project management and project execution - lead projects, facilitating timely execution.
• Initiate, own, and manage complex manufacturing-focused Change Controls, CAPAs, Planned Exceptions, and continuous improvement initiatives.
• Lead or support manufacturing investigations, deviation assessments, and root cause analyses using structured problem-solving methodologies to identify causes and implement effective corrective and preventative actions.
• Utilize technical experience, judgement, and precedent to identify, troubleshoot, and resolve straightforward technical and operational problems that arise.
• Proactively identify continuous improvement opportunities, share knowledge cross functionally, and drive site implementation.
• Partner with cross functional groups (e.g. Manufacturing, Manufacturing Sciences, Engineering, Automation, Quality, Planning, and Materials Management) to identify continuous improvement opportunities and drive implementation.
• Initiate and own the operational readiness for technology transfer of products into manufacturing and communicate across functional teams to ensure production schedules are met, collaborating with the technology transfer lead to fully transfer the products to the site.
• Act as subject matter expert for manufacturing processes and equipment while providing technical guidance and operational support during manufacturing execution.

Who You Are

You are a highly organized and detail-oriented professional who demonstrates advanced technical process knowledge, technical writing expertise, and a strong understanding of project management and manufacturing operations. You excel at bringing diverse teams together to achieve complex objectives and are comfortable leading initiatives across multiple functions without direct authority. You thrive in fast-paced environments, proactively manage competing priorities, and have a proven ability to drive efficiency, operational readiness, and manufacturing startup activities to successful completion.

You are a collaborative problem solver who can effectively communicate across all organizational levels, identify risks early, understand escalation trigger points, and influence outcomes through strong stakeholder engagement and project leadership.

Required Skills

Bachelor's degree from an accredited college or university is required. Direct experience may be considered in lieu of degree.

• At minimum 3 years of direct experience in a biotech, pharma, or an industry adjacent field.
• Prior experience in biopharmaceutical or biotechnology environments with strong knowledge of cGMP regulations.
• Strong root cause analysis and problem-solving experience with the ability to identify trends, investigate issues, and implement effective corrective actions.
• Experience authoring, reviewing, and maintaining technical documentation, procedures, work instructions, investigations, and manufacturing records.
• Intermediate to advanced skills in Microsoft Office and computer-based quality systems.
• Experience in Continuous Improvement, Operational Excellence, Manufacturing Excellence, or Process Improvement programs.

Preferred Skills

L