Jobs · Information Technology · North Carolina

Senior Associate Manufacturing - New Product Introduction Systems(Multiple Positions)

BioSpace · Holly Springs, NC · 1 mo ago
Information TechnologyFull-time
We need to output HTML fragment with sections: About the role? The posting includes description: "Live What You Will Do" etc. We need to use

for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title as heading. No Job ID. Remove boilerplate. We need to parse the posting: It includes intro: "HOW MIGHT YOU DEFY IMAGINATION? ..." then description about Amgen, facility, role title: Senior Associate Manufacturing - New Product Introduction Systems (Multiple Positions). Then "Live What You Will Do" then description of role. Then "Responsibilities" list. Then "Win What We Expect Of You" includes qualifications. Then "Thrive What You Can Expect Of Us" includes benefits and salary placeholder. We need sections: About the role (maybe from intro and role description). Responsibilities (list). Requirements (maybe basic qualifications). Qualifications (maybe preferred qualifications). Skills (maybe cross-functional coordination etc). Benefits (maybe from Thrive section). Pay (salary range placeholder: "[HR to input market pay range]" - that's not specific, it's placeholder, so we should NOT include Pay section because it's not real specific content. Schedule: none. We must not include sections with filler like "commensurate with experience". The Pay placeholder is "[HR to input market pay range]" which is not specific; we should omit Pay section. Benefits: The Thrive section lists many benefits: annual salary range placeholder, total rewards plan, health and welfare, financial plans, work/life balance, career development, comprehensive employee benefits package, retirement and savings plan, medical/dental/vision, life/disability, FSA, discretionary annual bonus, stock-based long-term incentives, award-winning time-off plans, bi-annual shutdowns, flexible work models. That's substantive. So we include Benefits section. About the role: We can combine the introductory paragraphs up to "Live What You Will Do". Provide a paragraph. Responsibilities: list from "Responsibilities" bullet points. Requirements: Basic Qualifications list. Qualifications: Preferred Qualifications list. Skills: maybe from "Win What We Expect Of You" includes skills like cross-functional coordination, meeting facilitation, technical writing, quality-system skills. Could be separate Skills section. But we might combine with Qualifications? The instruction: prefer few substantive sections over many thin ones. We could have About the role, Responsibilities, Requirements, Qualifications, Benefits. Skills could be part of Qualifications. But we have separate headings allowed; we can include Skills if there is distinct content. The "Win What We Expect Of You" includes both qualifications and skills. Could split: Requirements = Basic Qualifications; Qualifications = Preferred Qualifications; Skills = cross-functional coordination, meeting facilitation, technical writing, quality-system skills, ability to manage multiple priorities, communication, etc. That seems substantive. Thus sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits. We must not include Pay or Schedule. Now format: Use

for each heading. Then content: For prose use

. For lists use

  • . We need to preserve all substantive information, not invent or summarize away detail. Must not omit details. Let's extract exact text. About the role: From start until "Live What You Will Do". Let's capture: "HOW MIGHT YOU DEFY IMAGINATION? 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. Senior Associate Manufacturing - New Product Introduction Systems(Multiple Positions) Live What You Will Do" But we should not repeat the job title as a heading; but we can include it in the prose? The instruction: "Do NOT repeat the job title as a heading (the page already shows it)". It doesn't forbid including it in prose. However, we might want to keep it as part of About the role description. It's okay. But we should remove the "Live What You Will Do" heading? That's a heading in the posting but we are not to use headings other than

    for specific sections; we can treat that as part of prose. We'll just incorporate the description after that. Thus About the role paragraph: combine all that text up to before "Responsibilities". Let's capture: "HOW MIGHT YOU DEFY IMAGINATION? 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. Senior Associate Manufacturing - New Product Introduction Systems(Multiple Positions) In this vital role, you will be a key member of the Manufacturing Support team at the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant. This individual contributor will provide focused execution support for New Product Introduction (NPI) programs by coordinating cross-functional activities that enable compliant and timely implementation. The role will primarily work on Quality Risk Assessments, maintain associated Continuous Improvement records, create and maintain process Bills of Materials, and own assigned Change Control records under the guidance of NPI management. The position interacts broadly with Manufacturing, Quality, Process Development, Supply Chain, Manufacturing Execution Systems (MES), and Single-Use Systems (SUS) to align requirements, track execution, and maintain complete and inspection-ready documentation." We need to ensure we didn't miss any details. After that comes "Responsibilities". Good. Now Responsibilities list: The bullet points start with "Facilitate cross-functional Quality Risk Assessments (QRAs), ..." etc. We'll capture each as
  • . Let's list them exactly: - Facilitate cross-functional Quality Risk Assessments (QRAs), including planning sessions, coordinating participants and source information, guiding structured risk discussions, documenting decisions, and supporting review and approval. - Prepare and maintain QRA reports, Failure Modes and Effects Analyses (FMEAs), risk action logs, and supporting records in accordance with applicable procedures and quality requirements. - Create and maintain process Bills of Materials (BOMs) based on approved process and manufacturing requirements. - Coordinate BOM inputs, reviews, and reconciliation across Supply Chain, MES, SUS, Manufacturing, and other stakeholders to support accurate material readiness and alignment across systems and documents. - Own assigned NPI Change Control records under management guidance; prepare and maintain record content, coordinate required impact assessments and implementation planning, and manage records through applicable lifecycle phases. - Track pre-implementation, implementation, and post-implementation tasks, dependencies, due dates, and deliverables; follow up with task owners and escalate risks or delays. - Verify that task completion documentation includes the required objective evidence, traceability, and supporting information before routing for approval or closure. - Maintain trackers and provide clear, routine status readiness updates to NPI management and cross-functional partners. - Build effective relationships across functions, communicate moderately complex issues clearly, navigate ambiguity, and apply structured problem-solving to support timely execution. Now Requirements (Basic Qualifications): The text: "Basic Qualifications Masters degree ORBachelors degree and 4 years of Manufacturing or Operations experience ORAssociates degree and 8 years of Manufacturing or Operations experience ORHigh school diploma / GED and 10 years of Manufacturing or Operations experience" We need to format nicely. Probably as list. Thus: - Masters degree - Bachelors degree and 4 years of Manufacturing or Operations experience - Associates degree and 8 years of Manufacturing or Operations experience - High school diploma / GED and 10 years of Manufacturing or Operations experience Now Qualifications (Preferred Qualifications): list: - Degree in Science, Engineering, Supply Chain, Operations, or a related field. - Experience in GMP biotechnology or pharmaceutical manufacturing, manufacturing support, Process Development, Quality, or Supply Chain. - Experience facilitating cross-functional Quality Risk Assessments, FMEAs, or similar structured risk-management activities. - Experience using Quality Management Systems such as Veeva QMS or TrackWise for Change Controls, Continuous Improvement records, deviations, CAPAs, or risk-related records. - Experience creating or maintaining process or manufacturing Bills of Materials and coordinating material readiness across multiple functions. - Working knowledge of drug substance manufacturing and the relationship between process requirements, materials, manufacturing documents, and electronic batch records or MES. - Strong cross-functional project coordination, meeting facilitation, technical writing, and compliant documentation skills. - Ability to manage multiple priorities, maintain trackers, follow up on actions, and deliver work to established timelines. - Excellent written and verbal communication skills with the ability to build effective relationships in a matrix environment. - Ability to work independently within a defined scope, recognize when guidance is needed, and escalate risks promptly. Now Skills: Could be derived from the "Win What We Expect Of You" but we already used many of those as Qualifications. However we could separate skills like "Strong cross-functional project coordination, meeting facilitation, technical writing, and compliant documentation skills." etc. But to avoid duplication, maybe we keep Skills as those abilities not captured elsewhere: maybe "Ability to manage multiple priorities, maintain trackers, follow up on actions, and deliver work to established timelines." etc. But many are overlapping. Given instruction to prefer few substantive sections, we could combine Qualifications and Skills into one section called "Qualifications & Skills". But headings list includes both; we could decide to include only Qualifications and skip Skills to avoid thin sections. However the instruction: "Use

    for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It's just examples; we can omit sections if not substantive. So we could have About the role, Responsibilities, Requirements, Qualifications, Benefits. That's 5 sections. That seems good. Thus we will not include separate Skills section; we'll incorporate skill details into Qualifications (Preferred Qualifications). That avoids thin section. Now Benefits: from Thrive section. Let's extract benefits paragraph: "Thrive What You Can Expect Of Us As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being. The annual salary range for this opportunity in the U.S. is [HR to input market pay range]. In Addition To The Base Salary, Amgen Offers a Total Rewards Plan Comprising Health And Welfare Plans For Staff And Eligible Dependents, Financial Plans With Opportunities To Save Towards Retirement Or Other Goals, Work/life Balance, And Career Development Opportunities Including Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical

Similar jobs