Manufacturing Associate IV, OSM/OPM (ASO) (Days)

Biogen, Inc.; Northern (KY); Hybrid; USD 89,544,000 - 117,096,000; Full time

Benefits offered by this job

Medical Insurance

Tuition reimbursement

Paid vacation and holidays

401(k) matching

Job summary

Biogen is seeking a Manufacturing Associate IV to join the Drug Product facility in RTP. The role focuses on upstream and downstream ASO manufacturing, operating process equipment, and executing validation protocols in a cGMP environment.

You will document cGMP data, update batch records, and participate in training to support continuous improvement and audit readiness. This is an entry-level to mid-level manufacturing position with steady schedule expectations.

Qualifications

• Bachelor’s degree in STEM with 2+ years of direct experience.
• BioWorks certificate or associate’s degree with 2.5+ years of direct experience.
• High school diploma with 3+ years of direct experience.
• Experience in a cGMP environment and good documentation practices.
• Ability to follow SOPs and understand GDP.
• Understanding process automation and software systems like LIMS.

Responsibilities

• Execute daily manufacturing activities including operating process equipment and executing validation protocols per cGMP SOPs.
• Monitor critical upstream processes and troubleshoot equipment issues.
• Perform upstream and downstream ASO manufacturing operations in a cGMP setting.
• Document all cGMP data and deviations for steps and equipment activities.
• Create and update batch records, SLRs, and equipment logbooks.
• Conduct in-process sampling and analyses (e.g., pH, Osmolarity).
• Maintain a clean, audit-ready work environment.
• Participate in training and development for self and team.

Skills

Bachelor’s degree in STEM with 2+ yrs

BioWorks Certificate or associate's in

High School Diploma with 3+ yrs exp

cGMP environment experience

Follow SOPs & GDP

Process automation & LIMS familiarity

Education

Bachelor’s degree in STEM

BioWorks Certificate or associate's degree

High School Diploma or equivalent

Tools

LIMS

Job description

About This Role

Our Manufacturing Associates perform processing steps and manufacturing support activities in our Drug Product 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. This role’s primary focus is on upstream and downstream of ASO (antisense oligonucleotides).

Shift Details

Monday-Thursday 6 am to 4 pm There may be an occasional need for Friday and after-hours support

What You’ll Do

• Execute daily manufacturing activities, to include operating process equipment and executing validation protocols according to cGMP Standard Operating Procedures (SOPs)


• Perform and monitor critical upstream processes and troubleshoot operational and equipment problems


• Execute upstream and downstream ASO manufacturing operations in a cGMP-regulated environment, ensuring adherence to batch records, standard operating procedures, and production schedules


• 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


• Perform in-process sampling and sampling analysis (e.g., pH, Osmolarity,)


• Help maintain a clean and safe work environment, always focusing on audit readiness of process areas


• Actively participate 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 IV

$31.25 - $40.87 Pay Range

• 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)


• Understanding process automation and software systems (e.g. LIMS)

Physical Requirements

Ability to climb ladders, work in tight spaces, and lift/move equipment up to 50 lbs. Must be comfortable working in cleanroom environments with required gowning and able to stand for up to 3 hours at a time.

Job Level

Entry Level

Additional Information

The base compensation range for this role is: $31.25-$40.87 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.

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.

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.

Biogen is an E-Verify Employer in the United States.