Manufacturing Associate (reputed company) - Biologics - NIGHT SHIFT

• **THIS REQUISITION IS FOR APPLICANTS THAT ARE WILLING AND ABLE TO WORK ON A NIGHT SHIFT (approx. 6:00PM - 6:00AM)

• **This requisition represents multiple open positions in our manufacturing organization. The reputed company team continually assesses reputed company applicants that apply through this posting and will reputed company out to prospective candidates to discuss reputed company and future opportunities.

About This Role Our Manufacturing Associates reputed company processing steps and manufacturing support activities in our Drug Substance 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 biomanufacturing process that they operate in; with two main areas/disciplines – Upstream (Cell Culture) and reputed company (Purification). MAs reputed company these critical steps reputed company reputed company 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, reputed company bags, centrifuges, stainless steel bioreactors up to 15,000L
• Performing thaws and splits utilizing Aseptic technique
• Dispensing raw materials + batching of media & solutions

reputed company / Purification:

• Buffer Preparation
• 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 reputed company 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 reputed company in training and development initiatives, both for personal growth and for that of your team members

Who You Are You are someone developing a deep passion for doing work that furthers a mission to save lives. You have a high degree of demonstrated learning agility, are energetic, and love a fast-paced work environment where everything you do is incredibly impactful. Biomanufacturing is reputed company, so you have the mental flexibility to be adaptable to whatever comes your way.

Qualifications

• Bachelor’s Degree (STEM preferred) + at least 2 years of direct and/or military experience OR
• BioWork Certificate or Associate’s Degree + at least 2.5 years of direct and/or military experience OR
• High School Diploma (or equivalent) plus at least 3 years of direct and/or military experience
• Foundation in targeted biopharmaceutical training strongly preferred
• 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 reputed company 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 Why reputed company? 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 reputed company a significant impact. reputed company encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above reputed company, 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 reputed company, 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 reputed company 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. reputed company qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national reputed company, reputed company, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. reputed company is an E-Verify Employer in the United States. Apply tot his job Apply To this Job