Manufacturing Associate II / III, Solution Prep (Days)

Biogen, Inc.; Northern (KY); Hybrid; USD 32,000 - 47,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Paid time off

Job summary

Biogen, Inc. is seeking Manufacturing Associates to support media and solution preparation in a 12-hour shift environment on a 2-2-3 calendar. Roles operate in a clean room at RTP, following cGMP and SOPs to ensure timely production of therapies.

The job requires a STEM background (or related certificate) with experience in GMP settings, strong documentation, and willingness to work rotating days or nights. Biogen offers a comprehensive benefits package and growth opportunities.

Qualifications

• Bachelor’s degree in a STEM field or equivalent experience is preferred.
• BioWorks Certificate or related associate degree is considered.
• High School Diploma with relevant experience may be accepted.

Responsibilities

• Prepare media and process solutions per batch records and SOPs.
• Operate mixing equipment and support routine production and monitoring.
• Document activities in compliance with cGMP and SOP requirements.
• Collaborate with Manufacturing, MSAT, Quality, and Engineering teams.

Skills

Documentation

cGMP knowledge

Aseptic technique

Shift adaptability

Education

Bachelor’s degree (STEM)

BioWorks certificate

High School Diploma or equivalent

Job description

About This Role

Our factories run 24/7 operations. Our manufacturing teams work 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotation. Shift Details: This role follows a 2-2-3 calendar rotation on days (6:00 AM – 6:00 PM ET) Internal Shift Details: Red Days rotating schedule 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 Media & Solution Preparation

What You’ll Do

• Prepare media and process solutions in accordance with approved batch records, SOPs, and cGMP requirements
• Operate mixing equipment and execute manufacturing processes to support routine production and RCM (Routine Clean Monitoring) protocols
• Perform validation activities and collect RCM samples to support process compliance and manufacturing readiness
• Execute glass wash and autoclave operations to ensure equipment and materials are cleaned, sterilized, and available for manufacturing use
• Perform solution prep, run mixes, and execute protocols for RCMs Validation work and RCM sampling (routine clean monitoring) Glass wash and autoclave activities
• Accurately document activities in accordance with cGMP and SOP requirements
• Maintain a clean, safe, and compliant manufacturing environment
• Collaborate cross-functionally with Manufacturing, MSAT, Quality, and Engineering teams

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 II

$23.56 - $30.77 Pay Range

The following combination of academic and/or relevant experience may be considered:

• Bachelor’s degree from an accredited college or university, STEM preferred and 0+ years of direct experience
• A BioWorks Certificate or associate's degree, STEM preferred and 0+ years of direct experience
• A High School Diploma (or equivalent) and at minimum of .5 years of direct experience
• Previous experience in a GxP environment
• Ability to follow SOPs and work effectively on shift schedules if required
• Demonstrated documentation and data integrity skills
• Understanding of aseptic technique and cleanroom practices is preferred

Required Skills for a Manufacturing Associate III

$25.96 - $34.13 Pay Range

The following combination of academic and/or relevant experience may be considered:

• 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

Ability to follow SOPs and work effectively on shift schedules

Demonstrated documentation and data integrity skills

Knowledge of aseptic technique and cleanroom practices

Exposure to DeltaV, LIMS, Syncade, CMMS, Veeva, or similar systems

Prior experience with solutions preparation

Understanding of aseptic technique and cleanroom practices

Job Level: Entry Level

Additional Information

The base compensation range for this role is: $23.56-$34.13. Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation

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 Biogen.

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.