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open role · workday:biibhr

Manufacturing Associate II / III, Visual Inspections and Packaging (Days)

$BIIBResearch Triangle Park, NC· posted today
Manufacturing / CMCAssociateOncologyCell & Gene Therapy

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: Four 10-hour shifts per week, 6:00 am to 4:00 pm. Employees may be assigned to either a Monday-Thursday or Tuesday-Friday schedule.

Our Manufacturing Associates perform processing steps and manufacturing support activities in our Visual Inspection area in the Drug Product (Parenteral Filling) 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 manufacturing process that they operate in. The Visual Inspection Manufacturing Associates is responsible for performing manual and/or automated visual inspection of sterile drug product containers (vials, syringes, and cartridges) to ensure product quality and compliance with GMP requirements.

What You’ll Do

• Perform manual visual inspection of finished drug product units according to approved SOPs and work instructions

• Operate automated inspection equipment and support automated inspection activities

• Perform area setup, line clearance, and inspection booth verification activities.

• Execute bulk packaging related activities

• Accurately document and record all cGMP data and information, including deviations, for processing steps and equipment activities. Create and revise key documentation such as batch records, SLRs, and equipment logbooks

• Assist with in-process sampling and basic analytical testing as required

• Maintain a clean, safe, and compliant manufacturing environment

• Maintain a clean, safe, and compliant work environment, with a strong focus on inspection and audit readiness

• Collaborate effectively as a team member and demonstrate leadership through engagement, accountability, and operational excellence

• Actively participate in and support training and development initiatives for both personal growth and the development of 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 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 GMP 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

• Demonstrated experience working in a cGMP environment

• Strong documentation, compliance, and process execution skills

• Ability to lead tasks, support teams, and collaborate effectively across shifts

• Experience with cGMP and cleanroom practices

Preferred Skills

• Prior Parenteral Filling experience

• Experience with TrackWise, DeltaV, and LIMS systems

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.

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. 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 GMP 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 • Demonstrated experience working in a cGMP environment • Strong documentation, compliance, and process execution skills • Ability to lead tasks, support teams, and collaborate effectively across shifts • Experience with cGMP and cleanroom practices Preferred Skills • Prior Parenteral Filling experience • Experience with TrackWise, DeltaV, and LIMS systems 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

skills Bork detected

GMP
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