Job Description
About this Role
In this Large Scale Manufacturing (LSM) Sr. Manufacturing Specialist I role, you will be responsible for manufacturing support tasks including technical writing, project management, and process implementation. This position requires you to be highly detail oriented with excellent technical writing skills and a continuous improvement mindset.
What You'll Do
- Author manufacturing documentation including procedures, work instructions, logbooks, changeover protocols, batch production records, solution lot records and deliver on key stakeholder requirements with a minor degree of supervision.
- High level Project management and project execution - lead projects, facilitating timely execution.
- Utilizes technical experience, judgement, and precedent to identify, troubleshoot, and resolve straightforward technical and operational problems that arise.
- Proactively identifies continuous improvement opportunities, shares knowledge cross functionally, and drives 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 technology transfer of products into manufacturing and communicate across functional teams to ensure production schedules are met.
- Initiate, own, and manage complex manufacturing focused change controls, CAPAs, and planned exceptions, acting as SME.
- This site-based role supports MFG, primarily during core weekday business hours, but may require infrequent off-hours support.
Who You Are:
If you are a highly detailed and focused individual who demonstrates a moderate to advanced level of technical process knowledge, technical writing ability, and subject matter expertise with manufacturing processes and equipment, you would be a great fit for our Manufacturing Technical Operations Team! This position will provide you the opportunity to collaborate and innovate with a group of individuals who are all passionate about transforming patient lives
Qualifications
Required Skills:
- Bachelor's degree (Life Sciences or Engineering ) preferred, with 5 years of transferrable experience
- Associates Degree or Bioworks Certificate and 7 years of transferrable Experience
- High School Diploma (or Equivalent) 9 years of transferrable experience
Preferred Skills:
- Prior experience in manufacturing - drug substance biologics, downstream or upstream operations
- Understanding of business processes and roles of cross-functional groups supporting manufacturing operations
- Robust understanding of quality and cGMP principles
- Fundamental knowledge of change control in cGMP environment
- Intermediate to advanced skills in Microsoft Office and computer-based quality systems
- Intermediate to advanced level of technical writing skill
- Ability to interpret manufacturing process design documentation
- Excellent oral and written communication skills
Additional Information
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.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
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.