Jobs · Information Technology · New Jersey

Investigator I/II

BioSpace · Raritan, NJ · 1 mo ago
On-siteInformation Technology$73k–$96k/yrFull-time
We need to output only HTML fragment with headings

for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Use
  • for any list of duties/requirements/benefits, and

    for prose. Do NOT repeat job title as heading. Do NOT put Job ID/requisition numbers as headings. Remove boilerplate etc. Include sections only when posting has real specific content. Must preserve all substantive info. We need to parse the posting. First part: company description (Legend Biotech ...). That's about the company, maybe "About the role"? Actually "About the role" is a section heading we can use for overview. The posting includes "Role Overview" paragraph. So we can put that under

    About the role

    with

    containing that overview. Then "Key Responsibilities" ->

    Responsibilities

    with
    • each bullet. Then "Requirements" ->

      Requirements

      with
      • each bullet. Then "Benefits and Paid Time Off" ->

        Benefits

        with
        • each benefit. Then "Pay Range (Base Pay)" ->

          Pay

          with

          containing the range. Also "Other Types of Pay: Performance-based bonus and/or equity is available..." Could be part of Pay section. Schedule: Not mentioned. So we should not create Schedule section. Qualifications and Skills: The posting includes "Requirements" which includes qualifications and skills. Could separate but we can just have Requirements. The instruction says use headings for sections if content exists. We have Requirements; we could also have Skills if distinct. But we can combine. Safer to have Requirements only. We need to ensure we don't include boilerplate like EEO, Work Authorization, etc. Remove those. Also remove duplicated lines. Let's extract content. Company description: "Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide. Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma." That's about the company; could be part of About the role? Might be considered company overview. The instruction: "About the role" heading for section headings (e.g. About the role, Responsibilities...). So we can put company description under About the role? Actually "About the role" is more about the role overview. But we have a separate "Role Overview". We could combine company description and role overview under About the role. That seems okay. Let's extract Role Overview paragraph: "Legend Biotech is seeking a Investigator I/II as part of the Technical Operations team based in Raritan, NJ. Role Overview Investigator II independently leads and manages moderate- to high-complexity quality investigations related to manufacturing, engineering, facilities, equipment, and validation systems. This role assesses product quality, patient impact, and regulatory significance using a science- and risk-based approach; performs comprehensive root cause analyses; develops robust investigation reports, CAPAs, and effectiveness strategies; and ensures compliance with site procedures, regulatory requirements, and data integrity standards. Investigator II collaborates cross-functionally with subject matter experts and business partners to resolve complex quality events, support timely product disposition decisions, and drive continuous improvement initiatives." We need to preserve all substantive info. So we will include that. Now Responsibilities bullet list: Let's extract each bullet from "Key Responsibilities". The text after that is a long sentence with many items separated by periods? Actually it's a paragraph with many statements separated by periods but not bullet list. We need to convert to list items. The instruction: Use

          • for any list of duties/requirements/benefits. So we need to parse each duty as separate
          • . The text: "Independently lead end-to-end investigations related to manufacturing, facilities, engineering, equipment, validation, and other cross-functional quality events. Collect, review, and evaluate supporting investigation data, including manufacturing records, equipment logs, environmental monitoring data, maintenance records, validation documentation, and historical quality events. Conduct investigations related to facility and environmental monitoring excursions. Demonstrate the ability to prioritize and dynamically adjust workload based on business needs, product impact, and organizational priorities. Perform comprehensive risk and impact assessments related to product quality, patient safety, data integrity, and regulatory compliance. Timely Prioritize investigation activities and timelines to support patient batch disposition and release decisions using a robust risk-based approach and impact assessment, leveraging the required SMEs. Conduct detailed root cause analyses using various structured methodologies. Develop and own CAPA investigations; ensure timely closure and proper effectiveness checks. Drive and owns investigation meetings, cross-functional alignments and support resolution of complex quality events. Rapidly learn and develop a strong understanding of new manufacturing, engineering, validation, and facility processes to support effective and efficient investigations. Collaborate closely with SMEs, Quality leads, and cross-functional stakeholders to ensure investigations are thorough, scientifically sound, and inspection-ready. Support internal audits and regulatory inspections, including presenting investigation, findings, and conclusions to auditors and inspectors. Ensure all investigations are completed in accordance with established quality standards, regulatory requirements, and defined timelines. Contribute to continuous improvement initiatives related to investigation processes, documentation practices, systems, and quality tools. Demonstrate strong analytical thinking, critical reasoning, and problem-solving skills when evaluating complex quality events. Analyze investigation and deviation trends to identify recurring issues, systemic risks, and opportunities for proactive process improvements. Author clear, concise, and scientifically justified investigation reports suitable for regulatory review and inspection scrutiny. Provide guidance and technical support to junior investigators and cross-functional teams on investigation methodologies and root cause analysis techniques Recognize and escalate critical quality issues appropriately while ensuring timely communication with stakeholders and leadership. Utilize electronic quality management systems (eQMS) to manage investigations, CAPAs, effectiveness checks, and associated quality records." We need to split each line as
          • . Some lines have weird capitalization like "Timely Prioritize". We'll keep as is. Now Requirements bullet list: Extract from "Requirements". The text: "BS/BA in engineering, science, or related field. 4-6 years of cGMP experience within biotechnology, biopharmaceutical, pharmaceutical, or other regulated industries, and/or 2-4 years of quality investigation experience. Experience in engineering, facilities, equipment, validation, or quality systems is preferred. A combination of relevant industry, technical, and investigation experience will be considered. Demonstrated ability to independently manage multiple concurrent investigations while consistently meeting quality and timeliness expectations. Demonstrated proficiency in conducting moderate- to high-complexity investigations, performing risk assessments, identifying root causes, and developing effective corrective and preventive actions (CAPAs). Experience conducting product impact assessments and applying risk management principles in support of quality and disposition decisions. Experience reviewing and interpreting manufacturing, engineering, maintenance, calibration, environmental monitoring, and validation records to support investigation activities. Excellent technical writing and documentation skills, with the ability to independently author clear, concise, scientifically sound, and inspection-ready investigation reports. Working knowledge of electronic Quality Management Systems (eQMS) Demonstrated ability to effectively collaborate and influence crossfunctional teams in resolving complex quality events. Strong Ability to present investigation outcomes and respond to internal audit and regulatory inspection inquiries with minimal oversight. Technical knowledge of biologics, cell therapy, gene therapy, or pharmaceutical manufacturing processes. Proficiency in science- and risk-based decision-making and structured root cause analysis methodologies (e.g., 5 Whys, Fishbone, Fault Tree Analysis). Working knowledge of cGMP regulations, quality systems, and data integrity principles. Experience supporting regulatory inspections, audits, and health authority inquiries. Strong technical writing, communication, and presentation skills. Ability to independently manage multiple moderate- to high-complexity investigations. Proficiency with Microsoft Office and electronic Quality Management Systems (eQMS)." We need to split each line as
          • . Some lines have duplicate like "Working knowledge of electronic Quality Management Systems (eQMS)" appears twice? Actually appears once in requirements and later "Proficiency with Microsoft Office and electronic Quality Management Systems (eQMS)". We'll keep both. Now Benefits: Extract from "Benefits and Paid Time Off:" paragraph. "Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work." We need to split each sentence as
          • . Also note "Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech." That's also a benefit note; we could include as
          • but it's a restriction. Might be considered part of benefits. We'll include as
          • . Now Pay: Extract "Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles." and "Pay Range (Base Pay) $72,791 - $102,705 USD". Also earlier there were specific ranges for Investigator I and II. We should include that info. The posting includes: "This is a leveled position. Please see the salary ranges for each level below: Investigator I : $72,791 - $95,540 Investigator II: $78,251 - $102,705 The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws. Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles. Benefits and Paid Time Off: ... Pay Range (Base Pay) $72,791 - $102,705 USD" We need to preserve all substantive info. So we should include the level-specific ranges and the overall base pay range, plus other types of pay. We'll put under

            Pay

            a

            containing that info. Could also use

            • but it's not a list; it's prose. We'll use

              . Now Schedule: Not present, so omit. Now we need to ensure we don't include boilerplate like EEO, Work Authorization, etc. Remove those. Now produce HTML fragment. Structure:

              About the role

              ... company description + role overview ...

              Responsibilities

              • ...
              • ...

              Requirements

              • ...
              • ...

              Benefits

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