At Biogen, we work together to overcome obstacles and to follow the science. 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. Biogen is an E-Verify Employer in the United States.$29k-35k yearly est.7d ago
Manufacturing Associate III, Oligonucleotide Synthesis (OSM)
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. Biogen is an E-Verify Employer in the United States.$29k-35k yearly est.28d ago
* BioWork Certificate or Associate's Degree + at least 2.5 years of direct and/or military experience OR$29k-35k yearly est.60d+ ago
Manufacturing Coordinator V (LSM)
Job DescriptionJob Description The Coordinator V, Manufacturing Data and Performance role supports the RTP LSM Manufacturing Organization. Responsibilities include: coordinating changeover activities for manufacturing areas, authoring and revising standard operating procedures (SOPs), management of hoses, coordinate movement of equipment between manufacturing areas and offsite warehouse, and serve as the team's representative various cross-functional projects and human performance/continuous improvement initiatives. What You'll Do * Changeover: Coordinator will work with manufacturing, engineering and quality to facilitate changeover of a manufacturing area. Use Kneat to draft, review and approve electronic protocols. Use LIMs to generate sample labels and summary reports. Author/revise SOPs and perform SME assessments for GCCs as needed. * Hose management: Coordinator will work with manufacturing, engineering and external vendors in procuring hoses. Use CMMS to onboard new hoses, monitor hose expiry and withdraw/retire hoses that are expired or no longer in use. * Equipment Movement: Coordinator will work with manufacturing, engineering and warehouse to facilitate movement of equipment between manufacturing factories or to and from the offsite warehouse. Use CMMS to update equipment status and location. * Team Representative: Participate in meetings that may require support from the Manufacturing Coordination Team (ie. daily integrated working team meetings, Fit-For-Manufacturing (FFM)/Invasive PMs meetings, GCC Review Board (CRBs), Tech Transfers, Facility Shutdown Planning,etc.) * Human performance: Use Devonway to review open reports, workflow interrupters and continuous improvement ideas submitted by manufacturing. Coordinator may also provide support with implementation of continuous improvement ideas. Who you are You have a thorough understanding of the manufacturing process, including manufacturing support activities. You have strong technical knowledge, including understanding relevant engineering and scientific concepts as well as basic biotechnology process. You are a self-starter, need minimal direction and are a great communicator. Qualifications Required skills * Bachelor's degree of Life Sciences or Engineering preferred. Other educational levels accepted based on related experience in the field. * 4+ years of relevant experience, depending on educational and industry experience type. * Ability to work with relevant electronic systems. Preferred Skills * Possesses a thorough understanding of the manufacturing process, including manufacturing support activities. * Understands the theory and concepts behind the process, including an understanding of the impact of their own area on upstream and downstream activities. * Recognizes potential process and equipment problems. * Understands implications of test/process specifications, operating ranges, alert and action limits. * Writes new and edits existing documentation. * Understands basic biotechnology processing - purpose of major unit operations and microbial control concepts. * Must be able to demonstrate the ability to work independently, with minimal direction. * Good verbal and written skills are required to ensure proper description of any issues. * Experience with Kneat, LIMs, MyCims, CMMS (Infor), Microsoft Office (Word, Excel, Project) Additional Information Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive. Why Biogen? Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive. 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.$83k-115k yearly est.12d ago
Lead, Manufacturing- Cell Culture (Night Shift)
Job DescriptionJob Description This position follows a traditional 2-2-3 format from 6pm-6am About 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 well as maintaining equipment and facilities. This position works closely with shift Supervisor to coordinate critical activities collaboratively and utilizes resources efficiently. This is a key preparatory role for the Manufacturing Supervisor position. The Manufacturing Lead responsibilities include but are not limited to: * Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record, SLR and control system. Coordinates and/or leads process steps as required, serving as a process step(s) expert. * In coordination with Supervisor, schedules tasks for a given shift and plan resource allocation. This includes production, validation or other project activities. Also, responsible for proper information sharing at shift exchange and ensure all issues are communicated appropriately. * Documents/records and reviews cGMP data and information (including documentation of deviations) for processing steps and/or equipment activities, following standard operating procedures. Develops and/or revises documents as needed. Key documentation includes batch records, SLRs, and equipment logbooks. Ensure completeness of BPR/SLR real time review. * Actively participates in training activities, managing their own individual training plan. Provides training to other associates as required and shares knowledge with others. Observes performance of employees, provides timely and targeted coaching for employees, and provides feedback to Supervisor mid and end of year. * Initiates / investigates deviations, develops and implements corrective and preventative actions as required by supervisor. Leads and/or actively participates in troubleshooting. Serves as possible SME for audits. Who You Are: Our Small Scale Manufacturing Cell Culture team is looking for an agile self-starter who takes accountability, is willing to learn quickly in a dynamic environment, and prioritizes accurate and ethical data recordkeeping. The incumbent is expected to be an expert on multiple unit operations, have excellent technical understanding of the processes and equipment, and is skilled at leading, scheduling tasks, training, and supporting other associates. We prioritize the possession of a few soft skills in addition to technical experience, with the opportunity for continued career development and on the job training. Key soft skills to look for are teamwork, interpersonal skills for conflict resolution, teachability, patience, and willingness to follow procedures. Qualifications Required Skills * Bachelor's Degree in an engineering or scientific discipline preferred + 4 years of direct biomanufacturing experience * Associate degree in an engineering or scientific discipline preferred + 4.5 years of direct biomanufacturing experience * Certificate or HS diploma in an engineering or scientific discipline preferred + 5 years of direct biomanufacturing experience Preferred Skills * Prior Cell Culture, Harvest and Media prep experience in a leadership capacity * Lean, Six Sigma and 5S certifications * Experience with Trackwise, Delta V, and LIMS in addition to cGMP experience. * Highly detailed oriented with excellent documentation skills and exceptional troubleshooting abilities Additional Information All your information will be kept confidential according to EEO guidelines. Why Biogen? Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive. 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.$87k-113k yearly est.15d ago
Lead, Manufacturing- Cell Culture (Night Shift)
Job DescriptionJob Description This position follows a traditional 2-2-3 format from 6pm-6am 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 well as maintaining equipment and facilities. This position works closely with shift Supervisor to coordinate critical activities collaboratively and utilizes resources efficiently. This is a key preparatory role for the Manufacturing Supervisor position. The Manufacturing Lead responsibilities include but are not limited to: * Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record, SLR and control system. Coordinates and/or leads process steps as required, serving as a process step(s) expert. * In coordination with Supervisor, schedules tasks for a given shift and plan resource allocation. This includes production, validation or other project activities. Also, responsible for proper information sharing at shift exchange and ensure all issues are communicated appropriately. * Documents/records and reviews cGMP data and information (including documentation of deviations) for processing steps and/or equipment activities, following standard operating procedures. Develops and/or revises documents as needed. Key documentation includes batch records, SLRs, and equipment logbooks. Ensure completeness of BPR/SLR real time review. * Actively participates in training activities, managing their own individual training plan. Provides training to other associates as required and shares knowledge with others. Observes performance of employees, provides timely and targeted coaching for employees, and provides feedback to Supervisor mid and end of year. * Initiates / investigates deviations, develops and implements corrective and preventative actions as required by supervisor. Leads and/or actively participates in troubleshooting. Serves as possible SME for audits. Who You Are: Our Large Scale Manufacturing (LSM) Cell Culture team is looking for an agile self-starter who takes accountability, is willing to learn quickly in a dynamic environment, and prioritizes accurate and ethical data recordkeeping. The incumbent is expected to be an expert on multiple unit operations, have excellent technical understanding of the processes and equipment, and is skilled at leading, scheduling tasks, training, and supporting other associates. We prioritize the possession of a few soft skills in addition to technical experience, with the opportunity for continued career development and on the job training. Key soft skills to look for are teamwork, interpersonal skills for conflict resolution, teachability, patience, and willingness to follow procedures. Qualifications Required Skills * Bachelor's Degree in an engineering or scientific discipline preferred + 4 years of direct biomanufacturing experience * Associate degree in an engineering or scientific discipline preferred + 4.5 years of direct biomanufacturing experience * Certificate or HS diploma in an engineering or scientific discipline preferred + 5 years of direct biomanufacturing experience Preferred Skills * Prior Cell Culture, Seed Train and Inoculation Room experience in a leadership capacity * Biosafety cabinet and/or Bioreactor experience * Lean, Six Sigma and 5S certifications * Experience with Trackwise, Delta V, and LIMS in addition to cGMP experience. * Highly detailed oriented with excellent documentation skills and exceptional troubleshooting abilities Additional Information All your information will be kept confidential according to EEO guidelines. Why Biogen? Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive. 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.$87k-113k yearly est.15d ago
Sr. Supervisor, Manufacturing
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.$103k-131k yearly est.14d ago
Co-op, Parenteral Filling Manufacturing
At Biogen, our mission is clear - we are pioneers in neuroscience. Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. We at Biogen are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients who we serve. As an intern or co-op at Biogen, you can expect to be placed on a real project, under the guidance of experienced professionals and subject matter experts who are invested in your career and academic growth. To participate in the Biogen Internship Program, students must meet the following eligibility criteria:$35k-41k yearly est.60d+ ago
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.$41k-55k yearly est.29d ago
Manufacturing Coordinator V (LSM)
Job Description
The Coordinator V, Manufacturing Data and Performance role supports the RTP LSM Manufacturing Organization. Responsibilities include: coordinating changeover activities for manufacturing areas, authoring and revising standard operating procedures (SOPs), management of hoses, coordinate movement of equipment between manufacturing areas and offsite warehouse, and serve as the team's representative various cross-functional projects and human performance/continuous improvement initiatives.
What You'll Do
* Changeover: Coordinator will work with manufacturing, engineering and quality to facilitate changeover of a manufacturing area. Use Kneat to draft, review and approve electronic protocols. Use LIMs to generate sample labels and summary reports. Author/revise SOPs and perform SME assessments for GCCs as needed.
* Hose management: Coordinator will work with manufacturing, engineering and external vendors in procuring hoses. Use CMMS to onboard new hoses, monitor hose expiry and withdraw/retire hoses that are expired or no longer in use.
* Equipment Movement: Coordinator will work with manufacturing, engineering and warehouse to facilitate movement of equipment between manufacturing factories or to and from the offsite warehouse. Use CMMS to update equipment status and location.
* Team Representative: Participate in meetings that may require support from the Manufacturing Coordination Team (ie. daily integrated working team meetings, Fit-For-Manufacturing (FFM)/Invasive PMs meetings, GCC Review Board (CRBs), Tech Transfers, Facility Shutdown Planning,etc.)
* Human performance: Use Devonway to review open reports, workflow interrupters and continuous improvement ideas submitted by manufacturing. Coordinator may also provide support with implementation of continuous improvement ideas.
Who you are
You have a thorough understanding of the manufacturing process, including manufacturing support activities. You have strong technical knowledge, including understanding relevant engineering and scientific concepts as well as basic biotechnology process. You are a self-starter, need minimal direction and are a great communicator.
Qualifications
Required skills
* Bachelor's degree of Life Sciences or Engineering preferred. Other educational levels accepted based on related experience in the field.
* 4+ years of relevant experience, depending on educational and industry experience type.
* Ability to work with relevant electronic systems.
Preferred Skills
* Possesses a thorough understanding of the manufacturing process, including manufacturing support activities.
* Understands the theory and concepts behind the process, including an understanding of the impact of their own area on upstream and downstream activities.
* Recognizes potential process and equipment problems.
* Understands implications of test/process specifications, operating ranges, alert and action limits.
* Writes new and edits existing documentation.
* Understands basic biotechnology processing - purpose of major unit operations and microbial control concepts.
* Must be able to demonstrate the ability to work independently, with minimal direction.
* Good verbal and written skills are required to ensure proper description of any issues.
* Experience with Kneat, LIMs, MyCims, CMMS (Infor), Microsoft Office (Word, Excel, Project)
Additional Information
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
Why Biogen?
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
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.$83k-116k yearly est.14d ago
Lead, Manufacturing- Cell Culture (Night Shift)
$87k-113k yearly est.28d ago
Lead, Manufacturing- Cell Culture (Night Shift)
$87k-113k yearly est.26d ago
Sr. Supervisor, Manufacturing
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.$102k-130k yearly est.18d ago
