Manufacturing Associate III / IV, Small Scale Purification (Days)
Biogen
Summary
Our Manufacturing Associates perform processing steps and manufacturing support activities in our Drug Substance facility in Research Triangle Park (RTP). These teams are the backbone of our operations – each playing a critical role in delivering our therapies to the patients who need them. Our teams are organized by the steps in the biomanufacturing process that they operate in; including – Upstream (Cell Culture), Downstream (Purification), and Media & Solution Preparation. Manufacturing Associates perform these critical steps in a clean environment governed by Current Good Manufacturing Practices (cGMP). This role’s primary focus is Downstream (Purification): Column Chromatography, Viral Filtration, Ultra-Filtration, Bulk Dispensing of the drug substance.
Job description
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
- Assist in conducting in-process sampling and sampling analysis (pH, Conductivity, Protein Concentration, Osmolarity, etc.)
- 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
- Actively participate and lead in training and development initiatives, both for personal growth and for that of your team members
Who You Are
You’re driven by a mission to save lives and bring a deep sense of purpose to the work you do. Biomanufacturing is complex, and you thrive in fast-paced environments where learning agility, problem-solving, and adaptability are essential.
Required Skills for a Manufacturing Associate III
- Bachelor’s degree from an accredited college or university, STEM preferred and at minimum .5 years of direct experience
- A BioWorks Certificate or associate's degree, STEM preferred and at minimum 1 year of direct experience
- A High School Diploma (or equivalent) and at minimum of 1.5 years of direct experience
- Previous experience in a cGMP environment
- Demonstrated ability to follow Standard Operating Procedures (SOPs) and adhere to Good Documentation Practices (GDP)
- Experience or understanding of working in an aseptic or cleanroom environment
- Understanding of process automation and software systems (e.g. DeltaV, LIMS, etc.)
- Previous pipetting experience in a laboratory or manufacturing environment
Required Skills for a Manufacturing Associate IV
- Bachelor’s degree from an accredited college or university, STEM preferred and at minimum 2 years of direct experience
- A BioWorks Certificate or associate's degree, STEM preferred and at minimum 2.5 year of direct experience
- A High School Diploma (or equivalent) and at minimum of 3 years of direct experience
- Previous experience in a cGMP environment
- Demonstrated ability to follow Standard Operating Procedures (SOPs) and adhere to Good Documentation Practices (GDP)
- Experience working in an aseptic or cleanroom environment
- Understanding of process automation and software systems (e.g. DeltaV, LIMS, etc.)
- Previous pipetting experience in a laboratory or manufacturing environment preferred
- Exposure to single use consumables preferred
Requirements
- Bachelor’s degree from an accredited college or university, STEM preferred and at minimum .5 years of direct experience
- A BioWorks Certificate or associate's degree, STEM preferred and at minimum 1 year of direct experience
- A High School Diploma (or equivalent) and at minimum of 1.5 years of direct experience
- Previous experience in a cGMP environment
- Demonstrated ability to follow Standard Operating Procedures (SOPs) and adhere to Good Documentation Practices (GDP)
- Experience or understanding of working in an aseptic or cleanroom environment
- Understanding of process automation and software systems (e.g. DeltaV, LIMS, etc.)
- Previous pipetting experience in a laboratory or manufacturing environment
- Bachelor’s degree from an accredited college or university, STEM preferred and at minimum 2 years of direct experience
- A BioWorks Certificate or associate's degree, STEM preferred and at minimum 2.5 year of direct experience
- A High School Diploma (or equivalent) and at minimum of 3 years of direct experience
- Experience working in an aseptic or cleanroom environment
- Previous pipetting experience in a laboratory or manufacturing environment preferred
- Exposure to single use consumables preferred
Benefits
- Medical, Dental & Vision
- Life Insurance
- Fitness & Wellness Programs
- Short- & Long-Term Disability
- Paid Vacation
- Paid Holidays
- Sick Time
- Paid Maternity & Parental Leave
- 401(k) Matching
- Employee Stock Purchase Plan
- Tuition Reimbursement
- Employee Resource Groups
Company overview
Founded in 1978, Biogen is a leading global biotechnology company headquartered in Cambridge, Massachusetts, specializing in the development and commercialization of innovative therapies for serious neurological and neurodegenerative diseases. As one of the oldest independent biotechnology companies in the United States, Biogen has established itself as a pioneer in neuroscience, focusing on difficult-to-treat conditions where few or no treatment options exist. The company's portfolio includes groundbreaking treatments for multiple sclerosis, spinal muscular atrophy, Alzheimer's disease, ALS, and Friedreich's ataxia. With approximately 7,000 employees worldwide, Biogen operates through a global network that includes research and development hubs in Cambridge, Research Triangle Park in North Carolina, and South San Francisco, along with world-class manufacturing facilities in the United States and Switzerland. The company's commitment to scientific innovation is demonstrated by its Nobel Prize-winning founders and its receipt of the U.S. National Medal of Technology and Innovation. Biogen's patient-centric approach drives its mission to deliver transformative medicines that improve lives while creating sustainable value for shareholders and communities.