Principal Research Associate, Clinical Biomarker Laboratory

We need to output only HTML fragment, using

for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must include sections only when posting has real specific content. We must not repeat job title as heading. Must not include Job ID etc. Must preserve all substantive info, not invent or summarize away detail. Remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, application instructions. Also remove sections like "About Moderna", "Equal Opportunities", "Accommodations", "Export Control Notice" unless they contain relevant content? Those are boilerplate/EEO etc, should be removed. Also remove "Our Working Model" maybe not a standard heading; but we can incorporate into responsibilities? It's about onsite requirement. Could be part of Responsibilities or maybe a separate section like "Work Model" but not in allowed headings. Since only allowed headings are those listed, we should not create extra headings. So we need to fit content into those sections. We need to extract: - About the role: description of role, purpose, context. The first paragraph: "The Role Moderna is seeking an experienced and highly motivated Principal Research Associate to join the Clinical Biomarker Laboratory (CBL) Immunoassay and Cell Based Assay group. This laboratory-based role will primarily support the development, qualification, validation, and clinical implementation of ligand-binding assays (LBAs) and cell-based assay for biomarker and immunogenicity testing across Moderna's infectious disease, oncology, and autoimmune disease clinical programs. The successful candidate will have hands-on experience developing and executing on cell-based assays and Immuno-assays. The individual will independently perform assay development and optimization experiments, qualification/ validation experiments, clinical sample testing, data analysis, and documentation in a regulated clinical laboratory environment. Experience with virus neutralization or functional antibody assays, including cell culture-based neutralization assays and hemagglutination inhibition (HAI) assays will provide opportunities to support broader CBL immunogenicity assay activities. The Principal Research Associate will work closely with the clinical Biomarker Laboratory Lead, biostatisticians, Quality/ Compliance partners, and other cross-functional stakeholders to deliver high-quality, traceable, and regulatory-compliant bioanalytical data supporting Vaccine clinical development programs." That's suitable for About the role. - Responsibilities: The "Here’s What You’ll Do" list. Many bullet points. We need to put them in

• . Must preserve all substantive info. Let's extract each bullet: From "Here’s What You’ll Do" paragraph (looks like a run-on sentence). Let's split by periods? Actually it's a long sentence with many clauses separated by periods? Let's parse: "Develop analytical quality data standards related to GLP/ ICH/ GCP in accordance with existing SOPs across clinical studies and in collaboration with Laboratory Operations lead and scientific leaders at CBL. Responsible for gathering Quality data required to establish metrics and generate insights and daily oversight of the Data Quality procedures in place. Evaluate performance, risks, and alignment with current regulatory expectations. Serve as a cross-functional lead for key initiatives relating to Quality metrics and reporting. Collaborate with study personnel to ensure documentation review and corrections are complete throughout regulated studies and during QA audits. Act as Document Coordinator to track version changes of controlled documents, and distribution and training of new versions. Assist with maintaining the master schedule. Assist with development or revisions of SOPs Lead Quality analytics processes and develops analysis procedure and reporting mechanisms to improve GxP compliance. Support QC review/approval of clinical data generated from biomarker assays through analytical and cell-based assay methods. Participate in review of protocols, methods, reports, batch records and related GLP/GcLP source documents to actively manage data and documents by using various software like Excel, LabVantage LIMS (Laboratory Information Management System) database for clinical phase studies. Produce training manuals for the scientific and technical staff to ensure best practices are implemented. Collaborate with QA team and other functions towards the continued evolution of the Quality Management System (QMS) and execution of risk-based management solutions. Coordinate with internal and external groups to identify appropriate solutions to improve on clinical data analysis and Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results, in a fast-paced environment." There's a fragment "Coordinate with internal and external groups to identify appropriate solutions to improve on clinical data analysis and" incomplete; but we keep as is. We'll list each as
• . - Requirements: The "Here’s What You’ll Bring To The Table" section. Contains education, experience, knowledge, etc. We'll extract bullet-like items. List: "Bachelor's / Master’s/ PhD degree in Pharmaceutical Sciences or related industry with strong background in quality data analytics" "4 to 8 years of relevant clinical laboratory experience in pharmaceutical industry or CROs" "Knowledge in various lab-based techniques such as immunoassays, cell-based assays, cytometry, and other platforms for the investigation of biomarkers in clinical phase studies." "Knowledge of Bioanalytical method validation for Industry is preferred." "Knowledge of data management tools, and data integrity requirements such as with QC review of LIMS/ ELN/ LES system, RYZE, CDISC standard and data collection formats." "Prior experience in Developing and maintaining study-specific data management documentation, Data Management Plan, and Data Cleaning Plan documentation is preferred." "Previous experience in working in GxP or CAP/ CLIA, GLP regulated laboratory is highly preferred." "Previous experience in Lab management and Digital Automation is." (looks incomplete; maybe "Previous experience in Lab management and Digital Automation is a plus." We'll keep as is.) "Proficiency with Microsoft Office Suite (Outlook, Excel, Word, etc.)." "Proficiency with statistical analysis methodologies is a plus." "Attention to detail, organizational ability, judgement, team player attitude and effective communication skills." "Demonstrated ability of multi-tasking" We'll put each as
• under Requirements. - Qualifications: Might overlap with Requirements; but we can treat Qualifications as maybe education and certifications? However we already used Requirements for experience/knowledge. Could separate: Qualifications could be education and certifications. But we have no separate certifications. Could combine? The instruction: Use headings only when posting has real specific content for it. We have content for Requirements (experience, knowledge). We also have content for Qualifications (education degree). Could split: Qualifications: Bachelor's/Master's/PhD degree in Pharmaceutical Sciences or related industry with strong background in quality data analytics. That's a qualification. Requirements: the rest (experience, knowledge, skills). But we also have Skills section maybe for proficiency etc. Let's decide. We have sections allowed: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to allocate content appropriately without duplication. Let's map: - About the role: role description. - Responsibilities: the "Here’s What You’ll Do" list. - Qualifications: education degree (Bachelor's/Master's/PhD) maybe also "strong background in quality data analytics". Could also include "Prior experience in Developing and maintaining study-specific data management documentation..."? That's more experience. But we can keep qualifications as education and maybe "strong background in quality data analytics". We'll keep it simple. - Requirements: experience (4-8 years), knowledge of lab techniques, bioanalytical method validation preferred, knowledge of data management tools, prior experience in data management documentation, experience in GxP/CAP/CLIA/GLP lab, experience in Lab management and Digital Automation, proficiency with Microsoft Office Suite, proficiency with statistical analysis methodologies is a plus, attention to detail etc., demonstrated ability of multi-tasking. - Skills: maybe we could separate technical skills vs soft skills. But we already have many in Requirements. Could move soft skills to Skills: Attention to detail, organizational ability, judgement, team player attitude and effective communication skills, Demonstrated ability of multi-tasking. Also proficiency with statistical analysis methodologies is a plus could be skill. However we already used proficiency with Microsoft Office Suite maybe skill. Let's allocate: Requirements: experience years, knowledge of lab techniques, bioanalytical method validation, data management tools, prior experience in data management documentation, GxP/CAP/CLIA/GLP lab experience, Lab management and Digital Automation experience. Skills: Proficiency with Microsoft Office Suite, Proficiency with statistical analysis methodologies, Attention to detail, organizational ability, judgement, team player attitude and effective communication skills, Demonstrated ability of multi-tasking. - Benefits: The "Pay & Benefits" section includes benefits description. We'll extract benefits bullet points: "Competitive healthcare, plus voluntary benefit programs to support your unique needs" "A holistic approach to well-being, with access to fitness, mindfulness, and mental health support" "Family planning benefits, including fertility, adoption, and surrogacy support" "Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown" "Savings and investments to help you plan for the future" "Location-specific perks and extras" We'll put each as
• under Benefits. - Pay: The salary range: "$89,900.00 - $143,800.00." Also mention discretionary bonus etc. We'll include that as

  maybe. - Schedule: The "Our Working Model" says role is 100% onsite. Also mention smoke-free etc. That's schedule/working model. We'll put schedule: "This role is 100% onsite." Also maybe mention "As we build our company, we have always believed that an in-person culture is critical to our success." We'll keep concise. We must not include boilerplate like "Moderna is a smoke-free, alcohol-free, and drug-free work environment." That's not schedule but could be part of schedule? It's about work environment. Might be considered schedule? It's not exactly schedule but could be included as a note. However it's not strictly schedule; but we can include as part of schedule section maybe as additional detail. The instruction: include a section ONLY when posting has real, specific content for it. We have schedule content (onsite). We can also include the smoke-free etc as part of schedule? It's not schedule but could be considered working conditions. Might be okay to include in schedule section as extra detail. But we risk including boilerplate? It's not boilerplate; it's specific to Moderna. It's okay. We must not include Equal Opportunities, Accommodations, Export Control Notice, About Moderna, etc. Now produce HTML fragment with headings

  and content. Structure:

  About the role

  ... (paragraph)

  Responsibilities

  • ...
  ...

  Qualifications

  Bachelor's / Master’s/ PhD degree in Pharmaceutical Sciences or related industry with strong background in quality data analytics.

  Requirements

  • 4 to 8 years of relevant clinical laboratory experience in pharmaceutical industry or CROs
  • Knowledge in various lab-based techniques such as immunoassays, cell-based assays, cytometry, and other platforms for the investigation of biomarkers in clinical phase studies.
  • Knowledge of Bioanalytical method validation for Industry is preferred.
  • Knowledge of data management tools, and data integrity requirements such as with QC review of LIMS/ ELN/ LES system, RYZE, CDISC standard and data collection formats.
  • Prior experience in Developing and maintaining study-specific data management documentation, Data Management Plan, and Data Cleaning Plan documentation is preferred.
  • Previous experience in working in GxP or CAP/ CLIA, GLP regulated laboratory is highly preferred.
  • Previous experience in Lab management and Digital Automation is.

  Skills

  • Proficiency with Microsoft Office Suite (Outlook, Excel, Word, etc.)
  • Proficiency with statistical analysis methodologies is a plus.