Sr. Manufacturing Specialist I

Biogen • Research Triangle Park, NC

3d • Onsite

About The Position

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

Requirements

• 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.

Nice To Haves

• Lean Manufacturing and/or Six Sigma training or application experience.
• PMP certification or formal project management training.

Responsibilities

• 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 escalate barriers that could impact manufacturing startup or operational execution.
• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level