Sr. Manufacturing Specialist I

Biogen, Inc.; Northern (KY); Hybrid; USD 98,000 - 127,000; Full time

Benefits offered by this job

Medical, dental, vision, & life insur

Fitness & wellness programs

Paid vacation and holidays

401(k) with company match

Tuition reimbursement

Employee stock purchase plan

Job summary

Biogen, Inc. is seeking a Sr. Manufacturing Specialist I to support ASO, OSD, and L&P teams with technical writing, project management, and process implementation.

The role emphasizes attention to detail, structured problem-solving, and cross-functional collaboration in a fast-paced biotech setting. The position involves leading complex readiness activities, coordinating change controls and documentation, and driving continuous improvement across manufacturing startup activities.

Qualifications

• Minimum 3 years direct biotech/pharma experience.
• Experience authoring and maintaining manufacturing documentation and records.
• Strong knowledge of cGMP regulations and quality systems.

Responsibilities

• Serve as primary receiving-site operational readiness lead for product and process transfers.
• Develop and drive site readiness plans aligning startup activities across functions.
• Lead readiness reviews, governance meetings, action tracking, and stakeholder communications.
• Own change controls, CAPAs, and continuous improvement initiatives.
• Author and maintain manufacturing documentation with high accuracy and compliance.
• Lead or support investigations and root-cause analyses using structured problem-solving.

Skills

Technical writing

Project management

Continuous improvement

Root cause analysis

Cross-functional collaboration

Microsoft Office

GMP knowledge

Manufacturing operations

Education

Bachelor's degree

Tools

Documentation software

Computer-based quality systems

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 upscale 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.

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

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

Additional Information

The base compensation range for this role is: $98,000.00-$127,000.00. Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

• 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

Job Level: Professional

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid‑sized biotechnology company, we provide the stability and resources of a well‑established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life‑changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

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.