Ph3About This Role /h3pAs a Manufacturing Associate IV, you will be an integral part of the Aseptic Operations team, operating within a cGMP environment to ensure the highest standards of product quality and safety. Your primary focus will be on supporting aseptic processing activities conducted under a Biosafety Cabinet (BSC) in a Grade C environment. This role emphasizes precision, accountability, and compliance, requiring you to perform and document daily manufacturing operations with rigor and attention to detail. Your work will directly contribute to maintaining a controlled, compliant, and inspection‑ready manufacturing environment, ensuring that our products meet stringent quality standards critical to patient safety. This position offers the opportunity to demonstrate your expertise in aseptic operations while supporting weekend operations on a rotational basis. /ph3What You’ll Do /h3ulliExecute aseptic manufacturing operations under Biosafety Cabinets in a Grade C environment, following approved PRCDs and Work Instructions. /liliPerform material handling, preparation, and aseptic manipulations in alignment with contamination control strategies. /liliAdhere to gowning and decontamination requirements, ensuring seamless transitions between Grade C and Grade A environments. /liliApply approved cleaning and disinfection practices to materials and equipment before introducing them into controlled areas. /liliMonitor operations against batch records, promptly reporting any deviations or abnormalities. /liliEnsure accurate, complete, and timely GMP documentation in compliance with Good Documentation Practices (GDP). /liliEscalate issues or non-conformances following site procedures. /liliContribute to maintaining a controlled, compliant, and inspection‑ready manufacturing environment. /li /ulh3Who You Are /h3pYou are a detail‑oriented individual with a strong sense of discipline and the ability to follow procedures meticulously. Your commitment to GMP compliance is unwavering, and you consistently demonstrate a high level of focus and perseverance, particularly during repetitive aseptic operations. You take ownership of your work, holding yourself accountable for product quality and patient safety. You thrive in a team‑based, highly regulated environment and are flexible in supporting weekend shifts as needed – on call rotation. /ph3Required Skills /h3ulliMinimum of 5 years experience in a cGMP manufacturing environment. /liliStrong knowledge of aseptic techniques and contamination control principles. /liliProven ability to follow procedures, work instructions, and protocols accurately. /liliStrong attention to detail in both execution and documentation. /liliAbility to operate effectively in a structured, regulated manufacturing environment. /liliWorking knowledge (or ability to quickly learn) of manufacturing and quality systems such as DeltaV, Syncade, LIMS, and TrackWise. /li /ulh3Preferred Skills /h3ulliDemonstrated ability to perform precise aseptic operations within a Biosafety Cabinet (BSC). /liliExperience with enhanced gowning requirements and aseptic behaviors. /liliFamiliarity with decontamination techniques, such as IPA disinfection and controlled material transfer. /li /ulh3Job Level /h3pEntry Level /ph3Equal Opportunity Statement /h3pAll 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. /p /p #J-18808-Ljbffr