Director, CMC Quantitative Sciences

We need to output HTML fragment with sections: About the role? Actually the posting includes "The Role" intro, then "Here’s What You’ll Do" with subsections: Strategic & Technical Leadership, Project & Platform Oversight, Team Leadership & Talent Development, Cross-Functional & Regulatory Engagement, Innovation & Continuous Improvement. Then "Minimum Qualifications" (Here’s What You’ll Bring to the Table). Then "Preferred Qualifications". Then "Competencies". Then "Our Working Model". Then "Pay & Benefits". Then "About Moderna". Then "Equal Opportunities" etc but we must remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. So we should drop Equal Opportunities, Accommodations, etc. Also remove "Moderna is a smoke-free, alcohol-free, and drug-free work environment." maybe part of Pay & Benefits? It's separate but could be considered boilerplate? It's not EEO but still maybe considered boilerplate? The instruction: remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate. That line is not EEO but it's a policy statement; not sure. Might keep? Safer to keep as part of Pay & Benefits? It appears before Pay & Benefits heading. Could be considered a general statement; but we can keep as a paragraph under Pay & Benefits or as separate? Probably better to keep as a paragraph under Pay & Benefits? Actually it's separate line before Pay & Benefits heading. Could treat as a paragraph under Pay & Benefits? Might be considered boilerplate but not EEO. I'd keep it as a paragraph under Pay & Benefits? But the heading "Pay & Benefits" exists; we can include that line as a paragraph under that section. We must not repeat job title as heading. So no heading for "The Role". We'll start with maybe a

summarizing the role? The instruction: Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Use

• for any list of duties/requirements/benefits, and

  for prose. Do NOT repeat the job title as a heading (the page already shows it) and do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short

  or drop it. Thus we need sections: About the role (maybe a brief intro), Responsibilities (the "Here’s What You’ll Do" with subpoints), Requirements (maybe Minimum Qualifications), Qualifications (maybe Preferred Qualifications), Skills (maybe Competencies), Benefits (Pay & Benefits), Schedule (Our Working Model). Also maybe "About Moderna" could be omitted? Not in list of headings but could be considered "About the company"? Not required. The instruction says prefer a few substantive sections over many thin ones. We could combine some. We need to preserve ALL substantive information; do not invent or summarize away detail. So we must include all details from the posting, but we can format them as lists or paragraphs. We must not create sections with filler like "commensurate with experience". Not relevant. We need to decide which headings to use: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Actually Pay and Benefits are separate headings but we could combine? The instruction says use those headings for section headings. It lists examples: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we can have separate Pay and Benefits sections, but we could also combine if content overlaps. However we have content for Pay & Benefits together. Could split: Benefits section for benefits description, Pay section for pay info (but posting doesn't give specific pay). It says "Competitive healthcare..." etc. No specific salary. So we should not create Pay section if no specific pay info. The instruction: never create Pay/Schedule/Benefits sections unless the posting actually states them. It does state benefits, so we can have Benefits section. It does not state specific pay, so we should not create Pay section. It does state schedule (Working model: 100% onsite). So we can have Schedule section. Thus sections: About the role (intro paragraph), Responsibilities (list of duties), Requirements (minimum qualifications), Qualifications (preferred qualifications), Skills (competencies), Benefits (benefits description), Schedule (working model). Possibly also "About Moderna" could be omitted or included as part of About the role? Might be considered boilerplate? It's about company mission; could be kept as a paragraph under About the role? But we already have About the role for the role description. Could add a separate section "About Moderna" but not in list of headings; maybe we can treat as part of About the role? Safer to omit as it's not required and could be considered boilerplate? It's substantive about company but not required. The instruction: Prefer a few substantive sections over many thin ones. So we could omit About Moderna to keep sections thin. However we must preserve ALL substantive information; omitting About Moderna would lose info. So we need to include it somewhere. Could include as a paragraph under About the role? But About the role is supposed to be about the role, not company. Could add a section "About Moderna" even if not in list; but instruction says use

  for section headings (e.g. About the role, Responsibilities...). The "e.g." suggests those are examples, not exclusive list. So we can add other headings if needed. So we can include About Moderna as a heading. Thus headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Schedule, About Moderna. We must not repeat job title as heading. Good. Now we need to extract content. Let's parse the posting. Intro paragraph: "The Role Moderna is seeking an accomplished and visionary Quantitative Scientist to join our Chemistry, Manufacturing, and Controls Quantitative Sciences (CMC QS) team as a Director based in Norwood, MA. In this role, you will lead a small, high-impact team of statisticians and data scientists responsible for delivering advanced quantitative solutions across the product lifecycle, from regulatory filings and lifecycle management to automated monitoring of manufacturing and stability data. You’ll partner closely with colleagues across Process Development, Analytical Development, Quality, Manufacturing, and Digital to shape scientific strategy, guide regulatory submissions, and deploy data-driven tools that directly impact decision-making. Your deep understanding of CMC domains will enable you to identify the most effective approaches to complex technical questions and influence key business outcomes. This position requires someone who thrives at the intersection of science, systems, and strategy. You should be equally comfortable setting technical vision, navigating regulatory interactions, and translating statistical thinking into practical, scalable tools. The ideal candidate is self-motivated, scientifically curious, and an exceptional communicator. Your leadership will be essential in advancing Moderna’s mission, helping to expand our pipeline, accelerate global impact, and uphold our values of being Bold, Collaborative, Curious, and Relentless." That's the About the role content. Then "Here’s What You’ll Do" with subheadings: Strategic & Technical Leadership - Define and execute statistical strategies that support Moderna’s CMC and business objectives. - Provide expert statistical consultation to senior leaders and cross-functional teams; shape critical product and process decisions through robust data analysis. - Lead the design and application of complex experimental and statistical models for challenges such as stability, comparability, and lifecycle management. - Translate business needs into scalable data science solutions, including tools for real-time trending, root cause analysis, and shelf-life estimation. Project & Platform Oversight - Oversee a portfolio of high-impact projects spanning regulatory filings, lifecycle extensions, and digital tools; ensure scientific quality, timelines, and business alignment. - Serve as the senior statistical expert on critical programs; set standards, ensure consistency, and advise on methodology choices. - Lead the development and governance of analytics platforms, such as: stability data monitoring, CPV dashboards & architecture, automated investigation & trending tools - Drive best practices in data creation, pipelining, integration, and reproducibility across GMP and non-GMP environments. Team Leadership & Talent Development - Manage a team of CMC statisticians and data scientists (5 - 6 direct reports), overseeing both daily execution and long-term development. - Foster a culture of excellence, innovation, and continuous learning. - Mentor junior and senior team members; lead internal training and upskilling efforts to strengthen statistical thinking across the organization. Cross-Functional & Regulatory Engagement - Partner with Analytical Development, Process Development, Quality, Manufacturing, and Digital teams to embed statistical thinking into all phases of the product lifecycle. - Guide regulatory strategy for specifications, comparability, expiry, and post-approval changes. - Lead or support interactions with regulatory agencies, including authoring responses and presenting methodologies in formal meetings. - Contribute to ongoing initiatives such as seasonal variant updates and the expansion of commercial manufacturing capabilities. Innovation & Continuous Improvement - Stay at the forefront of statistical science, regulatory expectations, and biopharma technology. - Identify and adopt emerging tools, platforms, and methodologies that enhance the team’s effectiveness and agility. - Streamline statistical and data science workflows to reduce time to insight, improve decision-making, and scale innovation. We can combine all these bullet points under Responsibilities as a list. Now Minimum Qualifications: "Here’s What You’ll Bring to the Table:" then list: - PhD in Statistics or related discipline with 10+ years of relevant experience; MS degree in Statistics or related discipline with 10 - 15 years of relevant experience; or BS degree in Statistics or related discipline with 15+ years of relevant experience - Proven track record of leading and delivering complex statistical projects in a fast-paced, dynamic environment - Demonstrated leadership and mentorship skills, with the ability to inspire and develop a high-performing team - Deep expertise in statistical methods for CMC applications: stability, DOE, regression, multivariate analysis, control charts, etc. - Skilled in teaching non-statisticians basic & intermediate statistical methods - Robust storytelling and communication skills; comfortable translating complex concepts for non-technical stakeholders. - Strong programming skills in statistical and data science languages (e.g., R, Python, JMP, SAS) and experience deploying tools or dashboards (e.g., Spotfire, Power BI, Tableau). - Experience with automated process monitoring, digital data pipelines, and model governance. - Familiarity with biopharma regulatory expectations (ICH, WHO, USP) and participation in agency communications. We'll put these under Requirements as a list. Preferred Qualifications: - Understanding of manufacturing and analytical systems (e.g., LIMS, MES, OSI PI, SAP). - Understanding of GMP quality concepts used in pharmaceutical production and development - Experience in regulatory interactions and submissions, including eCTD submissions, response to health authority questions, and agency meetings - Experience with phase appropriate GMP principles - Understanding of risk analysis and risk-based decision making We'll put under Qualifications as a list. Competencies: list: - Strategic Decision-Making: Weighs business impact, scientific rigor, and operational feasibility to drive smart, timely decisions. - Prioritization & Focus: Knows what matters most. Avoids overengineering and focuses the team on high-value work. - Collaborative Leadership: Builds alignment and momentum across functions. Influences without authority and empowers others to lead. - Scientific Precision: Brings deep technical expertise and attention to detail, grounded in a genuine passion for data and discovery. - Executive Communication: Translates complexity into clarity. Communicates insights that are actionable, scalable, and aligned to business needs. - Agility & Growth Mindset: Embraces new information, adapts to change, and continuously evolves approaches to meet emerging challenges. We'll put under Skills as a list. Benefits: The paragraph under "Pay & Benefits" heading: "At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and