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Jobs · Analyst · North Carolina

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

Biogen · Triangle, NC · 1 wk ago
Analyst$31.25–$40.87/hrFull-time

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).

Schedule

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

Responsibilities

  • Execute daily manufacturing activities, including 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 and 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.

Requirements

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.

  • 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 years of direct experience.
    • A High School Diploma (or equivalent) and at minimum 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 of 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.

Pay

The base compensation range for this role is $31.25–$40.87 per hour. Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills and experience, job location, and internal equity.

Benefits

  • Medical, Dental, Vision, and Life insurances.
  • Fitness and 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 plus 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.

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.

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