Job Description
This is a full time, on site position with M-F business hours
About this Role
This Analyst II, Planning and Scheduling position is responsible for issuing and coordinating Manufacturing documentation, specifically, master production records (MPRs), to support manufacturing operations. This role ensures the effective version of the Master Production Records (MPRs) and Solution Lot Records (SLRs), and all associated sample labels are issued to the manufacturing floor according to the timing outlined in the production schedule. This role serves as a Subject Matter Expert in site issuance activities and can identify and execute continuous improvements to the issuance and surrounding processes They also serve as a utility player for the wider Site Scheduling organization with opportunities to support area schedulers with shop floor updates and huddle meetings.
What You'll Do
- Follows processes defined in procedures and work instructions to independently and with collaboration from Quality Assurance issue Batch Production Records (BPR), Solution Lot Records (SLR), and any associated labels according to the site master production schedule.
- Coordinates record issuance timing, label creation and communicates any issues to multiple cross-functional groups
- Reviews issued MPRs and associated labels against the Master Sample Matrix prior to issuing to the manufacturing floor.
- Partners with stakeholder groups to identify continuous improvement opportunities related to the MPR issuance process.
- Responsible for intermediate and bulk drug substance batch creation within inventory system.
- Identifies issues and brings a proposed solution to management. Participates on teams to identify improvement opportunities and brainstorm and execute solutions.
- Provides solutions on an atypical or infrequent basis based on well-established precedents or procedures to resolve simple technical and operational problems that arise.
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
- Bachelor's degree of Life Sciences or Engineering in addition to minimum 6 months of industry (GMP pharmaceutical/biotech) related experience
- Associates degree in addition to minimum 1 year of industry experience
- High School Diploma or equivalent in addition to minimum 2 years of industry experience
- Excellent oral and written communication skills
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 skills in Oracle or other inventory management software
- Intermediate to advanced level of technical writing skill
- Ability to interpret manufacturing process design documentation
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.