Senior Associate Manufacturing - Bulk Drug Substance Upstream - Days

We need to output HTML fragment with sections: About the role? The posting includes description. We need headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections if posting has real specific content. We need to parse content. First, there is introductory paragraph: "Join Amgens Mission of Serving Patients ..." That's about the role? Could be About the role. Then "Senior Associate Manufacturing - Bulk Drug Substance Upstream - Days" is title (not to repeat). Then "What You Will Do" etc. That's responsibilities. Then sections: "Compliance", "Operational Readiness & Facility Startup", "Process/Equipment/Facilities", "Administrative". Those could be part of responsibilities. Then "What We Expect Of You" includes Basic Qualifications, Preferred Qualifications. That's Requirements/Qualifications/Skills. Then "What You Can Expect Of Us" includes benefits, total rewards, base salary mention but no specific pay amount. It says "competitive and comprehensive Total Rewards Plans". No specific pay figure, so we should not create Pay section unless actual pay stated. Benefits: mention competitive benefits, total rewards, but not specific. Might be considered benefits content? It says "From our competitive benefits to our collaborative culture, we'll support your journey". That's vague. The rule: never create Benefits section unless posting actually states them. It does mention benefits generally but not specific. Might be considered not specific enough? It says "competitive benefits". That's still a statement about benefits. I'd include a Benefits section with that content? The rule: "never create Pay/Schedule/Benefits sections unless the posting actually states them." It does state benefits generally, so we can include Benefits section with that prose. Schedule: posting mentions schedule details: Monday-Friday 8am-5pm early phase, then 12-hour 2-2-3 schedule 5:45am-6:15pm later. Also mention may require work outside standard business hours, nonstandard shifts, etc. So we have specific schedule info. So we can include Schedule section. Pay: no specific salary, so omit Pay. Now we need to decide sections: About the role (intro), Responsibilities (What You Will Do + subparts), Requirements (Basic Qualifications), Qualifications (Preferred Qualifications), Skills (maybe communication, Microsoft Office, etc.), Benefits, Schedule. We must not repeat job title as heading. Use

for each section heading. We need to use

• for any list of duties/requirements/benefits. So we need to turn lists into
  • . For prose, use

    . We must preserve all substantive information, not invent or summarize away detail. So we need to include all details. Let's extract content. Intro paragraph: "Join Amgens Mission of Serving Patients Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027." We need to keep that as prose under About the role. Now Responsibilities: "What You Will Do Lets do this! Lets change the world! In this dynamic role, you will be anSenior Associate in the manufacturing organization at Amgen North Carolina (ANC) supporting the facility expansion program and facility startup. Thisessentialrole will be part of a team responsible for manufacturingcell cultureoperationsincluding seed train, SUBs, Perfusion, RTF, Stainless Steel BRXs, Depth Filtration and Centrifugation,while partnering across functions to ensure successful operational readiness, technology transfer, and rampup of manufacturing operations within the new facility. This role may require work outside standard business hours, including nonstandard shifts, as needed to support startup, commissioning and qualification (C&Q), and engineering execution.During this phase of thestartup, you will be expected toworkaMonday Friday schedule from 8am 5pm.As the business moves from C&Q to manufacturing operations, this essential positionwillwork ona 12-hour 2-2-3 schedule from 5:45 am to6:15pmsupporting our critical 24/7 manufacturing operations.As Amgen relies upon the regular attendance of all staff members to meet legitimate business needs, this role must be able to work assigned 12-hourshift, including during inclement weather, some holidays and requested overtime in support of our operations. During early phases, this role will focus on operational readiness, training, and startup execution. As the facility transitions to steadystate operations, the role will shift toward routine manufacturing execution and continuous improvement." Then subheadings: Compliance, Operational Readiness & Facility Startup, Process/Equipment/Facilities, Administrative each with bullet-like sentences. We need to turn those into lists. Let's extract each. Compliance paragraph: "Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and complianceInitiate Quality observations (Discrepancies, Deviations, Testing Results Analysis (TRA), etc.) as well as support or lead evaluations and investigations into quality observationsInteract with regulatory agencies as needed and guidedAssure proper gowning and aseptic techniques are always followed" We can split into separate items. Operational Readiness & Facility Startup: list items: - Support operational readiness activities for facility expansion and startup - Execute manufacturing readiness tasks including equipment preparation, procedure execution, and process walkthroughs - Participate in commissioning, qualification, and startup activities as trained and assigned - Provide operational feedback during startup activities to support safe, compliant, and efficient manufacturing - Support readiness planning through execution of training, procedures, workflows, and operational practices required for startup and rampup Process/Equipment/Facilities: list items: - Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment of assigned area - Run and monitor critical process tasks per assigned procedures - Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBR]) - Complete washroom activities: cleaning equipment, small to large scale, used in production activities - Identify, recommend, and implement innovative process improvements and optimizations related to daily routine functions - Assist in the review of documentation for assigned functions (i.e., equipment logs, EBRs, ESPs) - Collaborate cross-functionally (i.e., QA/QC, F&E (Facilities & Engineering), PPIC (Production Planning and Inventory Control), Mfg., PD (Process Development), Regulatory, etc.) in completing production activities - Responsible for recognizing and elevating problems during daily operations - Participate in the implementation of programs and CAPAs (Corrective Action Preventive Action) with an eye toward continuous improvement - Drive safety in all operations, and assist the manager in escalating concerns as needed - Maintain an organized, clean, and workable space Administrative: list items: - Draft and revise documents (SOPs, technical reports, and MPs) - Interacts with management as an advisor in planning and in escalating potential concerns with the schedule and/or process Now Requirements/Qualifications: "What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. The hard-working professional we seek is a team player with these qualifications. Basic Qualifications High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience ORAssociates Degree + 2 years manufacturing and/or other regulated environment experience ORBachelors Degree + 6 months manufacturing and/or other regulated environment experience ORMaster's Degree Preferred Qualifications Completion of NC BioWork Certificate ProgramExperience in biotechnology or pharmaceutical plant start upKnowledge and process experience within a cGMP manufacturing facility or other highly regulated environmentBasic understanding of Upstream operation (Vial Thaw, Inoculation/Cell Expansion, Single Use Bioreactor, Production Bioreactor, ATF, Harvest Centrifuge, Depth Filtration)Excellent verbal and written communication (technical) skillsProficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems" We need to separate Basic Qualifications and Preferred Qualifications. Could be Requirements section (basic) and Qualifications section (preferred). Skills could be communication, Microsoft Office, etc. But we already have those in preferred qualifications. Might combine. We need to avoid duplication. Let's decide: - About the role: intro paragraph. - Responsibilities: all the "What You Will Do" plus subcategories (Compliance, Operational Readiness..., Process/Equipment/Facilities, Administrative). Could be one big list. - Requirements: Basic Qualifications (the OR list). - Qualifications: Preferred Qualifications (the list). - Skills: maybe we can extract communication and Microsoft Office as skills, but they are already in preferred qualifications. Could still have Skills section with those items. But to avoid duplication, maybe we put them under Qualifications (preferred) and not separate Skills. However the instruction says we can have Skills section if posting has real specific content. It does mention "Excellent verbal and written communication (technical) skills" and "Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems". Those are skills. So we could have Skills section with those two items. But then we would duplicate content if also in Qualifications. Better to put them under Qualifications (preferred) and not have separate Skills. But we need to decide which sections to include. The instruction: "Prefer a few substantive sections over many thin ones." So we could combine Preferred Qualifications and Skills into one Qualifications section. But we already have Requirements (basic) and Qualifications (preferred). That seems fine. Thus sections: About the role, Responsibilities, Requirements, Qualifications, Benefits, Schedule. Now Benefits: "What You Can Expect Of Us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards." We need to keep that as prose under Benefits. Schedule: we have details: early phase Monday-Friday 8am-5pm; later 12-hour 2-2-3 schedule 5:45am-6:15pm; may require work outside standard business hours, nonstandard shifts, inclement weather, holidays, overtime. We'll put as prose or list? Could be list. Now we need to ensure we don't include boilerplate like EEO etc. Not present. Now produce HTML fragment with

    headings and appropriate

    or

    • . We must not include or . Just fragment. Let's craft. About the role:

      About the role

      ... intro paragraph ...

      Responsibilities:

      Responsibilities

      • ... items ...
      We need to include all responsibility items. Let's list them: - In this dynamic role, you will be an Senior Associate in the manufacturing organization at Amgen North Carolina (ANC)