Current jobs related to Senior Manufacturing Coordinator - Triangle Township - Biogen

  • Manufacturing Operations Coordinator

    2 weeks ago

    Triangle Township, United States Biogen Full time

    Job Title: Manufacturing Operations CoordinatorBiogen is seeking a highly skilled Manufacturing Operations Coordinator to join our team. As a key member of our manufacturing operations team, you will play a critical role in ensuring the smooth operation of our manufacturing processes.Key Responsibilities:Coordinate and support daily manufacturing activities,...

  • Manufacturing Lead

    4 weeks ago

    Triangle Township, United States Biogen Full time

    Job SummaryWe are seeking a highly skilled and experienced Manufacturing Lead to join our Large Scale Manufacturing Cell Culture team at Biogen. As a key member of our team, you will be responsible for leading and coordinating daily manufacturing operations in a cGMP environment, ensuring compliance to cGMP, and maintaining equipment and facilities.Key...

  • Biologics Manufacturing Supervisor

    2 weeks ago

    Triangle Township, United States Biogen Full time

    Job OverviewBiogen is seeking a highly skilled and experienced Senior Supervisor to join our Quality Assurance team at our Research Triangle Park facility. As a key member of our team, you will be responsible for ensuring compliance, driving excellence, and maintaining product integrity.Key ResponsibilitiesLead and develop a team of quality assurance...

  • Manufacturing Sciences Technical Expert

    4 days ago

    Triangle Township, United States Biogen Full time

    Job DescriptionThe Senior Engineer - Oligonucleotide Synthesis will provide technical expertise to the clinical, PPQ, and commercial manufacturing campaigns run within the OSM facility. Key responsibilities include:Support and lead Process Transfer teams, technical improvement projects, and technical process investigations as needed.Provide technical and...

  • Senior Industrial Engineer

    2 weeks ago

    Triangle Township, United States Biogen Full time

    Job SummaryWe are seeking a highly skilled Senior Industrial Engineer to join our Global Engineering & Facilities team. This role will be accountable for subject matter expertise in operational process improvements and modeling related to utilization and efficiency of manufacturing equipment, process unit operations, utilities, and facilities.Key...

  • Manufacturing Operations Lead

    7 days ago

    Triangle Township, United States Biogen Full time

    Job DescriptionThis position follows a traditional 2-2-3 format from 6am-6pm on Black Day Shift, ensuring seamless execution of daily manufacturing operations in a cGMP environment.The Manufacturing Lead performs and documents various tasks, including operation of process equipment, execution of validation protocols, and ensuring compliance to cGMP. This...

  • Manufacturing Operations Lead

    2 weeks ago

    Triangle Township, United States Biogen Full time

    Job SummaryWe are seeking a highly skilled and experienced Manufacturing Lead to join our Large Scale Manufacturing Cell Culture team at Biogen. As a key member of our team, you will be responsible for overseeing daily manufacturing operations in a cGMP environment, ensuring compliance to cGMP, and maintaining equipment and facilities.Key...

  • Manufacturing Specialist II

    2 months ago

    Triangle Township, United States Biogen Full time

    Job OverviewThis role involves working a 10-hour shift, either Monday to Thursday or Tuesday to Friday, with weekends required on a rotating schedule.A Manufacturing Specialist II will deliver customer-focused service and support within a dynamic manufacturing setting. Responsibilities include executing both corrective and preventative maintenance on various...

  • Manufacturing Process Engineer

    1 month ago

    Triangle Township, United States Biogen Full time

    Job Title: Sr. Engineer I, ManufacturingAbout the Role:We are seeking a highly skilled and experienced Sr. Engineer I to join our Manufacturing Engineering team. As a key member of our team, you will be responsible for designing, specifying, installing, and validating new process equipment, as well as providing engineering technical support and...

  • Senior Quality Assurance Associate

    4 weeks ago

    Triangle Township, United States Biogen Full time

    Job DescriptionThis position will work from 6 AM to 6 PM on a 2,2,3 rotation scheduleThe Senior Quality Associate I is responsible for contributing to key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) Drug Product Parenteral Facility. Specifically, this role will have primary quality...

  • Senior Materials Planner

    2 weeks ago

    Triangle Township, United States Biogen Full time

    Job OverviewBiogen is seeking a highly skilled Raw Materials Planner to join our team at the RTP-Bio Manufacturing Site. This role is critical in ensuring an adequate raw material supply to support clinical and commercial programs.The ideal candidate will collaborate with cross-functional teams, including Manufacturing, Warehouse, Quality, and Technical...

  • Senior Quality Assurance Associate

    4 weeks ago

    Triangle Township, United States Biogen Full time

    Job Title: Senior Associate III, Quality AssuranceAbout the RoleWe are seeking a highly skilled Senior Associate III to join our Quality Systems team at Biogen. As a key member of our team, you will be responsible for ensuring the quality and compliance of our products and processes.Key ResponsibilitiesManage regulatory and partner inspections, including...

  • Senior Quality Assurance Specialist

    2 weeks ago

    Triangle Township, United States Biogen Full time

    Job SummaryWe are seeking a highly skilled Senior Quality Assurance Specialist to join our Quality Systems team at Biogen. The successful candidate will be responsible for ensuring compliance with regulatory requirements and maintaining GMP activities at our RTP facility.Key Responsibilities:Manage regulatory and partner inspections, including inspection...

  • Senior Director of Engineering, Small Molecule and Antisense Oligonucleotide

    4 weeks ago

    Triangle Township, United States Biogen Full time

    About This RoleBiogen is seeking a highly experienced Senior Director of Engineering to lead the Small Molecule and Antisense Oligonucleotide (ASO) Engineering Technical Authority function. This key leadership role is accountable for engineering subject matter expertise in small molecule and ASO modalities, encompassing performance, design, qualification,...

  • Senior Facilities Engineer

    2 months ago

    Triangle Township, United States Biogen Full time

    Job OverviewPosition SummaryThe Senior Facilities Engineer plays a crucial role in providing technical engineering support and validation for plant utilities and facility operations. This position is integral to cross-functional teams aimed at enhancing and optimizing existing processes. Collaborating with various departments such as Utilities,...

  • Senior Quality Assurance Associate

    1 week ago

    Triangle Township, United States Biogen Full time

    Job SummaryWe are seeking a highly skilled Senior Quality Assurance Associate to join our team at Biogen. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality of our products and processes.Key Responsibilities:Ensure compliance with regulatory requirements and site procedures.Assess criticality of exceptions...

  • Senior Quality Associate I

    1 week ago

    Triangle Township, United States Biogen Full time

    Job SummaryThis role will contribute to key strategic, tactical, and operational aspects within Quality Assurance at Biogen's Research Triangle Park (RTP) Drug Product Parenteral Facility.Key ResponsibilitiesEnsure product documentation and other documents supporting batch execution are compliant and determine acceptability for use in cGMP production...

  • Senior Utilities Technician

    1 month ago

    Triangle Township, United States Biogen Full time

    Job SummaryWe are seeking a highly skilled and experienced Utilities Technician to join our team at Biogen. As a key member of our Utility Operations team, you will be responsible for operating and maintaining our plant utility systems, including GMP and Non-GMP environments.Key ResponsibilitiesOperate and maintain plant utilities, including medium pressure...

  • Senior Living Activities Coordinator

    1 week ago

    West Bloomfield Township, Michigan, United States Sunrise Senior Living Full time

    About the Role:Sunrise Senior Living is seeking a dedicated and passionate Activities & Volunteer Coordinator to lead the day-to-day activities and programs for our community. As a key member of our team, you will be responsible for creating engaging experiences for our residents, fostering a sense of community, and promoting a culture of inclusivity and...

  • Senior Manager Manufacturing Engineering

    3 weeks ago

    Macomb Township, United States DAPRA Full time

    You will be joining the company at an exciting time of growth. The Senior Manager, Manufacturing Engineering and Operations is a key member of the engineering and production team. You will perform your complex duties in a highly-visible role to senior leadership reporting directly to the CEO. You will lead key activities and influence business results in...

Senior Manufacturing Coordinator

2 months ago

Triangle Township, United States Biogen Full time
Job Overview

Position Summary: The Manufacturing Lead is responsible for overseeing and documenting daily operations within a cGMP (current Good Manufacturing Practice) environment. This role includes the operation of process equipment, execution of validation protocols, and ensuring compliance with regulatory standards. The Manufacturing Lead collaborates closely with the shift Supervisor to efficiently coordinate critical activities and manage resources effectively. This position serves as a preparatory step towards the Manufacturing Supervisor role.

Key Responsibilities:

  • Conducts manufacturing processes and support activities, ensuring adherence to batch records and control systems. Takes the lead on specific process steps as necessary, acting as an expert in those areas.
  • Works with the Supervisor to schedule tasks for the shift and allocate resources effectively, which includes production and validation activities. Responsible for effective communication during shift changes.
  • Documents and reviews cGMP data, including deviations, in accordance with standard operating procedures. Develops and revises necessary documentation, ensuring completeness and accuracy of batch records and equipment logbooks.
  • Engages in training initiatives, managing personal training plans, and providing guidance to other team members. Observes and evaluates employee performance, offering constructive feedback to the Supervisor.
  • Initiates investigations into deviations and implements corrective actions as directed by the Supervisor. Actively participates in troubleshooting efforts and may serve as a Subject Matter Expert during audits.

Candidate Profile:

The ideal candidate for this role is a proactive self-starter who takes ownership of their responsibilities, is eager to learn in a fast-paced environment, and values precise and ethical data management. Candidates should possess expertise in multiple unit operations, a strong technical understanding of processes and equipment, and be adept at leading teams, scheduling tasks, and training others. We emphasize the importance of soft skills alongside technical experience, offering opportunities for career advancement and on-the-job training. Key soft skills include teamwork, conflict resolution, adaptability, patience, and adherence to procedures.

Qualifications:

  • Bachelor's Degree in an engineering or scientific discipline with a minimum of 4 years of relevant biomanufacturing experience.
  • Associate Degree in an engineering or scientific discipline with at least 4.5 years of relevant biomanufacturing experience.
  • High School diploma or equivalent with a minimum of 5 years of relevant biomanufacturing experience.

Preferred Qualifications:

  • Experience in Cell Culture, Harvest, and Media preparation in a leadership role.
  • Certifications in Lean, Six Sigma, and 5S methodologies.
  • Familiarity with Trackwise, Delta V, and LIMS systems, along with cGMP experience.
  • Strong attention to detail, exceptional documentation skills, and proficient troubleshooting capabilities.

Why Join Biogen?

At Biogen, we are dedicated to fostering a culture of excellence and innovation. As a mid-sized biotechnology company, we combine the stability of an established organization with an environment that encourages individual contributions. Our team consists of talented professionals who are passionate about learning, growth, and skill development. Together, we strive to deliver transformative medicines, with every role playing a crucial part in our mission. We are committed to building a diverse and inclusive workplace that reflects the communities we serve, ensuring that every employee feels valued and inspired.