Manufacturing Associate II

6 days ago


Triangle Township, United States Biogen Full time
Job DescriptionJob DescriptionJob Description

ob Description

This position will work 12-hour DAY SHIFTS (approx. 6:00am - 6:00pm) on a 2-2-3 rotation

About This Role

Manufacturing Associates perform processing steps and manufacturing support activities in our facilities in Research Triangle Park (RTP). These teams are the backbone of our operations – each person playing a critical role in delivering our therapies to the patients who need them. This position will be in our Parenteral Filling operations, and our teams operate across the following units:

  • Component Preparation
  • Compounding
  • Parenteral Filling/Lyophilization
  • Visual Inspection

 What You’ll Do

  • Execute daily manufacturing activities, to include operating process equipment and executing validation protocols according to cGMP Standard Operating Procedures (SOPs)
  • Document and record all cGMP data & information (including deviations) for processing steps and equipment activities. Create and revise key documentation like batch records, SLRs, and equipment logbooks
  • Help maintain a clean and safe work environment, always focusing on audit readiness of process areas
  • Be a team player and leader; always showing up to contribute your energy and focus
  • Assist in investigations of procedural deviations
  • Adhere to aseptic gowning and operating procedures
  • Actively participate and lead in training and development initiatives, both for personal growth and for that of your team members

Who You Are

You are someone developing a deep passion for doing work that furthers a mission to save lives. You have a high degree of demonstrated learning agility, are energetic, and love a fast-paced work environment where everything you do is incredibly impactful. Biomanufacturing is complex, so you have the mental flexibility to be adaptable to whatever comes your way.

Qualifications

  • Bachelor’s Degree (STEM preferred) OR
  • BioWork Certificate or Associate’s Degree OR
  • Military training & experience OR
  • High School Diploma (or equivalent) plus at least 6 months of directly transferrable experience


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.

 



  • Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionAbout This RoleThe Manufacturing Engineer II designs, specifies, installs, commissions and validates new process equipment, provides engineering technical support and troubleshooting for assigned process equipment and a GMP biological manufacturing area such as Cell Culture, Harvest or Purification.  The...


  • Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionThe Associate II, Quality Assurance Biologics will perform a wide variety of activities to ensure the quality and safety of our products. Primarily, this role provides on-the-floor quality oversight of GMP manufacturing activities. Those activities include review of batch record pages, logbooks, equipment reports,...


  • Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionAbout this RoleIn this Large Scale Manufacturing (LSM) Manufacturing Specialist II 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...


  • Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionAbout this RoleIn this ASO (Antisense Oligonucleotide synthesis and purification) and OSD (Oral Solid Dosage) Manufacturing Specialist II role, you will be responsible for manufacturing support tasks including technical writing, project management, and process implementation. This position requires you to be...


  • Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionAbout This RoleThis position is on a 12-hour rotation, Night shift on a 2, 2, 3 scheduleThis position is responsible for the supervision of manufacturing of clinical and commercial products under GMP conditions. The incumbent will supervise Manufacturing Associates on either a day, night, or hybrid shift;...

  • Investigator II

    6 days ago


    Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionAbout This RoleThis site-based role supports Small Scale manufacturing, primarily during core weekday business hours, but may require off-hours support.The Investigator II is responsible for maximizing organizational learning and improvement from Quality deviations. This team applies systematic and analytical...


  • Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionThis position will work 12-hour DAY SHIFTS (approx. 6:00am - 6:00pm) on a 2-2-3 rotationAbout This RoleManufacturing Associates perform processing steps and manufacturing support activities in our facilities in Research Triangle Park (RTP). These teams are the backbone of our operations – each person...


  • Research Triangle Park, United States Biogen Full time

    ob DescriptionThis position will work 12-hour DAY SHIFTS (approx. 6:00am - 6:00pm) on a 2-2-3 rotationAbout This RoleManufacturing Associates perform processing steps and manufacturing support activities in our facilities in Research Triangle Park (RTP). These teams are the backbone of our operations – each person playing a critical role in delivering our...

  • Lead, Manufacturing

    1 month ago


    Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionThis position follows a traditional 2-2-3 format from 6am-6pmAbout This Role: The Manufacturing Lead performs and documents daily manufacturing operations in a cGMP environment including operation of process equipment, execution of validation protocols, revising cGMP documents, ensuring compliance to cGMP, as...

  • Lead, Manufacturing

    1 month ago


    Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionJob DescriptionThis position follows a traditional 2-2-3 format from 6am-6pmAbout This Role: The Manufacturing Lead performs and documents daily manufacturing operations in a cGMP environment including operation of process equipment, execution of validation protocols, revising cGMP documents, ensuring compliance...

  • Lead, Manufacturing

    1 month ago


    Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob Description This position follows a traditional 2-2-3 format from 6am-6pmAbout This Role: The Manufacturing Lead performs and documents daily manufacturing operations in a cGMP environment including operation of process equipment, execution of validation protocols, revising cGMP documents, ensuring compliance to cGMP, as...


  • Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionJob DescriptionAbout This RoleThis position is on a 12-hour rotation, Day shift on a 2, 2, 3 scheduleThis position is responsible for the supervision of Small Scale Cell Culture manufacturing of clinical and commercial products under GMP conditions. The incumbent will supervise Manufacturing Associates on either a...


  • Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionAbout This Role:This critical position provides operational oversight of the Manufacturing Technical Operations (MTO) function for the Small Scale Manufacturing (SSM) and Flexible Volume Manufacturing (FVM) factories at out RTP Bio Site. This position will ensure tech transfers are properly supported with the...


  • Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionAbout this RoleIn this Small Scale Manufacturing (SSM) Manufacturing Specialist II 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...


  • Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionThis position will work 12-hour NIGHT SHIFTS (approx. 6:00pm - 6:00am) on a 2-2-3 rotationAbout This RoleManufacturing Associates perform processing steps and manufacturing support activities in our facilities in Research Triangle Park (RTP). These teams are the backbone of our operations – each person...


  • Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionAbout This RoleThe Manufacturing Engineer III designs, specifies, installs, commissions and validates new process equipment, provides engineering technical support and troubleshooting for assigned process equipment and a GMP biological manufacturing area such as Cell Culture, Harvest or Purification.  The...


  • Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionAbout This RoleThe Engineer III Manufacturing designs, specifies and installs new equipment and provides engineering technical support and troubleshooting for assigned process equipment and area assets.  Develops validation protocols, oversees validation testing and drafts final reports.  Provides project...


  • Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionAbout This RoleThe Sr. Engineer II provides engineering technical support and troubleshooting for plant utilities and facilities. Participates in multi-functional teams to implement changes and improve on existing processes. This position partners with other teams including Utilities, Manufacturing, Process...


  • Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionAbout This RoleThe Sr. Engineer II provides engineering technical support and troubleshooting for plant utilities and facilities. Participates in multi-functional teams to implement changes and improve on existing processes. This position partners with other teams including Utilities, Manufacturing, Process...


  • Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionAbout This RoleThis position is on a 12-hour rotation, Night shift on a 2, 2, 3 scheduleThis position is responsible for the supervision of manufacturing of clinical and commercial products under GMP conditions. The incumbent will supervise Manufacturing Associates on either a day, night, or hybrid shift;...