Manufacturing Associate (Experienced) - Biologics - NIGHT SHIFT

Futureshaper.com; North Carolina; On-site; USD 50,000 - 78,000; Full time

Job summary

An established industry player is seeking dedicated Manufacturing Associates to join their dynamic team in Research Triangle Park. This role is critical in the biomanufacturing process, where you'll engage in upstream and downstream activities, ensuring high-quality production of life-saving therapies. With a commitment to excellence and a strong focus on teamwork, you'll contribute to a mission that impacts lives while enjoying a comprehensive benefits package. If you thrive in a fast-paced environment and are passionate about making a difference, this opportunity is perfect for you.

Benefits

Fitness & Wellness programs

Short- and Long-Term Disability insurance

Paid vacation and holidays

401(k) program with company match

Tuition reimbursement up to $10,000

Employee stock purchase plan

Qualifications

• Experience in biomanufacturing and process equipment operation.
• Knowledge of cGMP and documentation practices.
• Ability to work in a fast-paced, dynamic environment.

Responsibilities

• Execute daily manufacturing activities and operate process equipment.
• Document all cGMP data and assist in sampling analysis.
• Maintain a clean and safe work environment focused on audit readiness.

Skills

Cell Culture

Chromatography

Aseptic Technique

Good Manufacturing Practices (GMP)

Documentation Skills

Communication Skills

Learning Agility

Education

Bachelor's Degree (STEM preferred)

BioWork Certificate

High School Diploma

Tools

DeltaV

LIMS

Job description

Manufacturing Associate (Experienced) - Biologics - NIGHT SHIFT

Research Triangle Park, NC, United States

50,000 - 78,000 USD

Job Description

***This requisition represents multiple open positions in our manufacturing organization. The Talent Acquisition team continually assesses all applicants that apply through this posting and will reach out to prospective candidates to discuss current and future opportunities.

***Our factories run 24/7 operations. Our manufacturing teamswork 12-hour shifts (either Days or Nights) on a2-2-3 calendarrotation

About This Role

Our Manufacturing Associates perform processing steps and manufacturing support activities in ourDrug Substancefacility in Research Triangle Park (RTP). These teams are thebackboneof 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; with two main areas/disciplines –Upstream(Cell Culture) andDownstream(Purification). MAs perform these critical steps within Current Good Manufacturing Practice (cGMP) biosafety cabinets and cleanroom suites. Some of the activities include:

Upstream / Cell Culture:

• Mammalian cell culture & harvest:
  • Work in Shake flasks, WAVE bags, centrifuges, stainless steel bioreactors up to 15,000L
  • Performing thaws and splits utilizing Aseptic technique
  • Dispensing raw materials + batching of media & solutions

Downstream / Purification:

• Column Chromatography
• Viral Filtration
• Ultra-Filtration
• Bulk Dispensing of the drug substance

What You’ll Do

• Execute daily manufacturing activities, to include operating process equipment and executing validation protocols according to cGMP Standard Operating Procedures (SOPs)
• 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
• Assist in conducting in-process sampling and sampling analysis (pH, Conductivity, Protein Concentration, Osmolarity, Cell Counts, etc.)
• Help maintain a clean and safe work environment, always focusing on audit readiness of process areas
• Be a team player and leader; always showing up to contribute your energy and focus
• Actively participate and lead in training and development initiatives, both for personal growth and for that of your team members

Who You Are

You are someone with a deep passion for doing work that furthers a mission to save lives. Biomanufacturing is complex, so you have a high degree of demonstrated learning agility and love a fast-paced work environment where everything you do is incredibly impactful.

Qualifications

Manufacturing Associate III:

• Bachelor’s Degree (STEM preferred) + at least 6 monthsof directly transferrable experienceOR
• BioWork Certificate or Associate’s Degree + at least 1 year of directly transferrableexperienceOR
• High School Diploma (or equivalent) plus at least 1.5years of direct and/or military experience

Manufacturing Associate IV:

• Bachelor’s Degree (STEM preferred) + at least 2 years of directly transferrable experienceOR
• BioWork Certificate or Associate’s Degree + at least 2.5 years of directly transferrable experienceOR
• High School Diploma (or equivalent) plus at least 3 years of directly transferrable experience

Manufacturing Associate V:

• Bachelor’s Degree (STEM preferred) + at least 4years of directly transferrable experienceOR
• BioWork Certificate or Associate’s Degree + at least 4.5 years of directly transferrable experienceOR
• High School Diploma (or equivalent) plus at least 3 years of directly transferrable experience
• Foundation in targeted biopharmaceutical training
• Experience executing and troubleshooting Cell Culture equipment (bioreactors) and processes
• Ability to interpret and apply Good Manufacturing Practices (GMP) knowledge, including documentation
• Understanding of process automation and software systems (e.g. DeltaV, LIMS, etc.)
• Ability and desire to influence and encourage others
• Demonstrated experience employing learning agility
• Adaptable to changing needs and demands, comfortable navigating a dynamic environment
• Excellent communication skills (both verbal and written) throughout all levels of the organization
• Ability to lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds
• Capable of working twelve (12) hour shifts (we operate both day and night shifts)

Additional Information

The base salary range for this position is MA III: $25.48 - 33.17 per hour, MA IV: $30.29 - 39.42 per hour, MA V: $32.69 - 42.31 per hour.This is an hourly, non-exempt position and in accordance with Biogen Pay Policy, may be eligible for shift differentials and overtime pay. 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:

• 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

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 DE&I efforts.

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.