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

Biogen; North Carolina; On-site; USD 43,000 - 56,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Fitness reimbursement

Disability insurance

Vacation and holidays

401(k) matching

Employee stock purchase plan

Tuition reimbursement

Employee Resource Groups

Job summary

Biogen in Research Triangle Park (RTP), NC, is seeking a Manufacturing Associate IV to execute daily manufacturing steps, operate process equipment, and ensure cGMP compliance in our Drug Product facility. This role focuses on upstream/downstream operations, in-process sampling (pH, osmolarity), documentation of batch records, and maintaining an audit-ready, cleanroom environment.

Shift: Mon–Thu 6 am–4 pm with occasional Friday and after-hours support; base pay range $31.25–$40.87 per hour, with

Qualifications

• Bachelor's degree from an accredited college or university, STEM preferred, and at minimum 2 years of direct experience.
• BioWorks Certificate or associate's degree, STEM preferred and at minimum 2.5 year of direct experience.
• 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).

Responsibilities

• Execute daily manufacturing activities, to include operating process equipment and executing validation protocols according to cGMP 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, SOPs, 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

Skills

SOP adherence

GDP adherence

Problem solving

Learning agility

Education

Bachelor's degree STEM

BioWorks Certificate/associate degree

High School Diploma + 3 years experience

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.

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

• 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 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 wher