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Manufacturing Associate (Recent Grad / Entry Level) - Biologics

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) OR
  • BioWork Certificate or Associate’s Degree OR
  • Military training & experience and are soon to transition OR
  • High School Diploma (or equivalent) plus at least 6 months of related experience
  • Foundation in targeted biopharmaceutical training is preferred, but not required
  • Strong desire to learn and grow quickly - demonstrated experience employing learning agility
  • Adaptable to changing needs and demands, comfortable navigating a dynamic environment
  • Strong communication skills (both verbal and written) and ability to work as a part of a team
  • 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.

 

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Average salary estimate

$60000 / YEARLY (est.)
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$50000K
$70000K

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What You Should Know About Manufacturing Associate (Recent Grad / Entry Level) - Biologics, Biogen

Are you a recent grad looking to kickstart your career in the biotechnology field? Biogen is excited to invite you to apply for the Manufacturing Associate position in Research Triangle Park, NC! Our 24/7 operations require enthusiastic team members who thrive in dynamic environments. As a Manufacturing Associate, you’ll play a crucial role in our Drug Substance facility, helping deliver life-changing therapies to patients. In this role, you will integrate into either the Upstream (Cell Culture) or Downstream (Purification) teams, mastering processes like mammalian cell culture and viral filtration. Your daily tasks will involve operating high-tech process equipment, adhering to current Good Manufacturing Practices (cGMP), and maintaining meticulous documentation. You’ll also engage in sampling and analysis while fostering a clean, safe workspace. This position isn’t just about the tasks; it’s about embracing a mission that saves lives, developing your skills, and contributing significantly to our team. If you're passionate about biomanufacturing, adaptable, and eager to learn, we want you on our side. Join us at Biogen, where your work truly makes a difference and every role counts!

Frequently Asked Questions (FAQs) for Manufacturing Associate (Recent Grad / Entry Level) - Biologics Role at Biogen
What are the primary responsibilities of a Manufacturing Associate at Biogen?

As a Manufacturing Associate at Biogen, you'll be engaged in critical operational processes within our Drug Substance facility. Your primary responsibilities will involve executing daily manufacturing activities under cGMP guidelines. This includes handling cell culture, operating bioreactors, preparing buffers, and conducting in-process sampling. Documentation is essential, so you'll maintain comprehensive records related to equipment and processing steps, ensuring our manufacturing standards are always met.

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What qualifications do I need to apply for a Manufacturing Associate position at Biogen?

To apply for a Manufacturing Associate role at Biogen, you should have a Bachelor’s Degree in a STEM field or equivalent experience, such as a BioWork Certificate or military training. While a foundation in biopharmaceutical training is preferred, it’s not mandatory. What’s crucial is having a strong desire to learn and the ability to adapt to a fast-paced environment, as well as effective communication skills.

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What does the training process look like for new Manufacturing Associates at Biogen?

New Manufacturing Associates at Biogen will undergo comprehensive training that emphasizes safety and operational excellence. This includes hands-on learning in both Upstream and Downstream processes, as well as in-depth education on cGMP standards. Ongoing mentorship is provided, allowing you to grow and develop in your role while actively participating in team initiatives and personal development.

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How does Biogen ensure a safe and clean work environment for Manufacturing Associates?

Biogen prioritizes a clean and safe work environment for all Manufacturing Associates. We maintain strict adherence to cGMP guidelines and conduct regular audits to ensure compliance. You will play an active role in keeping process areas audit-ready and contribute to maintaining a workspace that is safe, orderly, and conducive to high-quality production.

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What is the work schedule like for a Manufacturing Associate at Biogen?

Manufacturing Associates at Biogen work in a 12-hour shift rotation (Days or Nights) on a 2-2-3 calendar. This means you'll work two days, two nights, and have three days off in a rotating cycle, allowing for a balanced work-life dynamic while supporting our 24/7 operations.

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Common Interview Questions for Manufacturing Associate (Recent Grad / Entry Level) - Biologics
What experiences do you have that are relevant to the Manufacturing Associate role at Biogen?

When answering this question, draw from both educational background and any practical experiences, such as internships or projects. Highlight specific skills you've acquired that relate to biomanufacturing processes or troubleshooting techniques, showcasing how your experiences make you a suitable candidate for Biogen.

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How do you handle working in a fast-paced and constantly changing environment?

To effectively respond, share instances where you've successfully adapted to new challenges, whether during college projects or part-time jobs. Emphasize your learning agility and eagerness to embrace changes, which are vital traits for a Manufacturing Associate at Biogen.

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Can you describe a time you've worked collaboratively in a team?

Highlight a specific collaborative project or group activity, detailing your role and how you contributed to achieving a common goal. Stress the importance of communication and teamwork, as these are crucial in a manufacturing setting.

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What do you know about current Good Manufacturing Practices (cGMP)?

When answering, outline your understanding of cGMP and its impacts on product quality and safety in biomanufacturing. Show that you’re aware of the high ethical and operational standards in place at companies like Biogen, and express a commitment to adhering to these practices.

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How do you ensure effective documentation during manufacturing processes?

Discuss the importance of meticulous documentation in ensuring compliance and quality. You might mention organizational skills and attention to detail as key traits that help you maintain thorough records, which aligns with Biogen's standards.

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What methods do you use to prioritize tasks during busy shifts?

Describe a strategy you’ve used to prioritize responsibilities effectively. Consider mentioning time management techniques and how you assess urgent tasks, ensuring that you contribute to smooth operations, whether it’s during peak processing periods or routine operations.

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Why do you want to work for Biogen as a Manufacturing Associate?

Express your enthusiasm for being part of a company dedicated to life-changing therapies. Discuss Biogen's reputation for excellence and innovation, and share how your values align with the company’s mission to improve patient lives.

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How do you stay motivated during long shifts?

Share personal strategies for maintaining energy and focus during long hours, such as taking small breaks or setting personal milestones. Stress the importance of team encouragement in maintaining morale on challenging days.

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What personal strengths do you bring to the Manufacturing Associate role?

Reflect on your strengths that are relevant to the position, such as adaptability, communication skills, and a desire for continuous learning. Provide examples of how these strengths have helped you in past experiences, especially in high-stakes team environments.

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How would you approach a scenario where you notice a deviation from established procedures?

Convey a proactive and responsible mindset toward compliance and safety concerns. Explain that you would first document the deviation and report it to a supervisor following established protocols, demonstrating your commitment to cGMP and the company’s principles.

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Full-time, on-site
DATE POSTED
January 13, 2025

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