Manufacturing Associate (Experienced) - Biologics

Job Description

Job Description

Job Description

This requisition represents multiple open positions in our manufacturing organization. The Talent Acquisition team continually assesses all applicants that apply through this posting and will reach out to prospective candidates to discuss current and future opportunities.

Our factories run 24 / 7 operations. Our manufacturing teams work 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotation

About This Role

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; with two main areas / disciplines Upstream (Cell Culture) and Downstream (Purification).

MAs perform these critical steps within Current Good Manufacturing Practice (cGMP) biosafety cabinets and cleanroom suites.

Some of the activities include :

Upstream / Cell Culture :

• Mammalian cell culture & harvest :
• Work in Shake flasks, WAVE bags, centrifuges, stainless steel bioreactors up to 15,000L
• Performing thaws and splits utilizing Aseptic technique
• Dispensing raw materials + batching of media & solutions

Downstream / Purification :

• Buffer Preparation
• Column Chromatography
• Viral Filtration
• Ultra-Filtration
• Bulk Dispensing of the drug substance

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, Cell Counts, 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 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) + at least 2 years of direct and / or military experience OR
• BioWork Certificate or Associate’s Degree + at least 2.5 years of direct and / or military experience OR
• High School Diploma (or equivalent) plus at least 3 years of direct and / or military experience
• Foundation in targeted biopharmaceutical training strongly preferred
• Experience executing and troubleshooting Cell Culture equipment (bioreactors) and processes
• Ability to interpret and apply Good Manufacturing Practices (GMP) knowledge, including documentation
• Understanding of process automation and software systems (e.g. DeltaV, LIMS, etc.)
• Ability and desire to influence and encourage others
• Demonstrated experience employing learning agility
• Adaptable to changing needs and demands, comfortable navigating a dynamic environment
• Excellent communication skills (both verbal and written) throughout all levels of the organization
• Ability to lift and / or move up to 25 pounds and occasionally lift and / or move up to 50 pounds
• Capable of working twelve (12) hour shifts (we operate both day and night shifts)

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.