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Job details

Manufacturing Associate II-Parenteral Filling

Job Description

This position will work 12-hour Day Shifts (approx. 6:00AM - 6:00PM) on a 2-2-3 rotation

About This Role

Manufacturing Associates perform processing steps and manufacturing support activities in our facilities in Research Triangle Park (RTP). These teams are the backbone of our operations – each person playing a critical role in delivering our therapies to the patients who need them. This position will be in our Parenteral Filling operations, and our teams operate across the following units:

· Component Preparation

· Compounding

· Filling

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

· 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

· Assist in investigations of procedural deviations

· Adhere to aseptic gowning and operating procedures

· 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

Required

· Bachelor’s Degree (STEM preferred) OR

· BioWork Certificate or Associate’s Degree OR

· High School Diploma (or equivalent) plus at least 6 months of directly transferrable experience

· Capable of working twelve (12) hour shifts in a predetermined schedule rotation

· Ability to lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds

· 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

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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What You Should Know About Manufacturing Associate II-Parenteral Filling, Biogen

Are you ready to make an impact in the world of biomanufacturing? Join Biogen as a Manufacturing Associate II-Parenteral Filling in beautiful North Carolina, where your role is pivotal in ensuring that life-changing therapies reach the patients who need them. As part of our dynamic team at the Research Triangle Park, you’ll engage in essential processing steps and support activities, operating within our Parenteral Filling operations. Your daily tasks will involve executing manufacturing activities with precision, executing validation protocols, and keeping meticulous records in accordance with cGMP guidelines. Don't worry if you're new to this; we provide robust training to help you excel in your role and grow with us! We’re seeking passionate individuals who thrive in a fast-paced environment and have a knack for teamwork and adaptability. Whether you hold a Bachelor’s degree in STEM, a BioWork Certificate, or even just a high school diploma with relevant experience, what matters most is your eagerness to learn. Enjoy working a structured 12-hour day shift, while contributing to a culture that values inclusion and personal development. Together, we can achieve excellence and change lives, as every team member at Biogen plays a crucial role in our mission to innovate and advance healthcare.

Frequently Asked Questions (FAQs) for Manufacturing Associate II-Parenteral Filling Role at Biogen
What are the primary responsibilities of a Manufacturing Associate II-Parenteral Filling at Biogen?

As a Manufacturing Associate II-Parenteral Filling at Biogen, you'll be tasked with executing essential manufacturing processes such as operating equipment, documenting cGMP data, and maintaining a clean work environment. You’ll also assist in training initiatives and readiness for audits, playing a vital role in producing medicines that truly change lives.

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What qualifications are required for the Manufacturing Associate II-Parenteral Filling position at Biogen?

To apply for the Manufacturing Associate II-Parenteral Filling role at Biogen, a Bachelor’s Degree in a STEM field is preferred. However, candidates with a BioWork Certificate, an Associate’s Degree, or a high school diploma with transferrable experience are also encouraged to apply. Important skills include strong communication and adaptability in a fast-paced environment.

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What does a typical work schedule look like for a Manufacturing Associate II-Parenteral Filling at Biogen?

The Manufacturing Associate II-Parenteral Filling position at Biogen involves working 12-hour day shifts on a 2-2-3 rotation, which means you'll have scheduled days on and off. This shift work allows you to balance time at work while also having ample time to recharge.

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How does Biogen support the development of its Manufacturing Associates II-Parenteral Filling?

Biogen values the growth of its employees and offers various training and development initiatives for Manufacturing Associates II-Parenteral Filling. You will actively participate in training programs designed to enhance your technical skills and industry knowledge, fostering both personal growth and team dynamics.

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What is the work environment like for a Manufacturing Associate II-Parenteral Filling at Biogen?

The work environment for a Manufacturing Associate II-Parenteral Filling at Biogen is dynamic and collaborative. You’ll work closely with a diverse team in a state-of-the-art facility, committed to maintaining a safe and clean workspace while adhering to strict regulatory standards.

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Common Interview Questions for Manufacturing Associate II-Parenteral Filling
What experience do you have with cGMP standards?

When answering this question, highlight specific instances where you followed cGMP protocols in your previous roles. Demonstrate your understanding of the importance of compliance in manufacturing environments and share examples of documentation in your past experiences.

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How do you handle working in a team-oriented environment?

Emphasize your teamwork skills and provide examples from previous experiences. Discuss how you communicate effectively and collaborate with team members to achieve common goals while maintaining a positive work atmosphere.

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Can you explain your understanding of the Parenteral Filling process?

Discuss your familiarity with the Parenteral Filling process, mentioning any relevant experiences. Focus on the steps involved, such as component preparation, filling, and the importance of maintaining aseptic conditions to ensure product safety.

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How do you prioritize tasks during your shift?

Describe your method for staying organized and managing competing tasks. Illustrate with an example of how you effectively prioritized your workload while maintaining quality and adhering to deadlines in a previous job.

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What motivates you to work in the biomanufacturing field?

Share your passion for biomanufacturing and how it aligns with your desire to make a positive impact in healthcare. Mention any personal experiences that reinforce your commitment to developing and delivering life-changing therapies.

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How would you respond to a procedural deviation when it occurs?

Explain your proposed approach to any procedural deviations, emphasizing the importance of immediate reporting, investigation, and documenting the incident accurately. This shows your commitment to maintaining high manufacturing standards.

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Describe a time when you had to adapt quickly to a change in the work environment.

Use this opportunity to demonstrate your flexibility and problem-solving skills. Provide a specific example of a situation where you successfully adapted to changes and the positive outcome that followed.

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What roles have you undertaken in training or guiding team members?

Detail your experience with training or mentoring colleagues, emphasizing your ability to foster an environment that encourages learning and growth. Discuss any specific training programs or individual coaching you have provided.

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How do you ensure safety in the workplace?

Share your strategies for promoting safety in the workplace, such as following protocols, staying vigilant, and participating in safety training. Providing a concrete example can give your answer more weight.

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What do you consider as success for a Manufacturing Associate II-Parenteral Filling?

Discuss the key performance metrics you believe define success in this role, such as maintaining high production quality, ensuring compliance with cGMP standards, and fostering teamwork. Mention how these align with Biogen's mission to deliver quality therapies.

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Full-time, on-site
DATE POSTED
April 6, 2025

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