Sr. Scientist, Analytical Development

We need to output HTML fragment with sections: headings

for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must only include sections that have real specific content. We must not repeat job title. No Job ID. Remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, application instructions. Also remove "Our Working Model" maybe not a standard heading; but we could treat as part of About the role? The instructions: Use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we should map content to these headings. We have content: The Role description (first paragraph) and "Here’s What You’ll Do" list. That's responsibilities. Then "Here’s What You’ll Bring to the Table (Basic Qualifications)" and "(Preferred Qualifications)" -> qualifications/requirements. Then "Our Working Model" maybe about schedule? It says 100% onsite. That's schedule/working model. Then "Pay & Benefits" section includes benefits description. Also "About Moderna" maybe not needed. "Equal Opportunities" etc boilerplate to remove. "Accommodations" also boilerplate. We need to preserve all substantive information, not invent. So we need to extract responsibilities list, qualifications list, benefits, schedule (onsite). Pay: not specified; we should not create Pay section unless posting actually states them. There's no explicit pay. So omit Pay. Benefits: we have a paragraph describing benefits: "Competitive healthcare, plus voluntary benefit programs..." etc. That's substantive. So include Benefits section. Schedule: we have "Our Working Model" describing 100% onsite. That's schedule. So include Schedule section. Qualifications: we have Basic and Preferred qualifications. Could combine into Requirements/Qualifications. Use

for Requirements or Qualifications. Probably "Qualifications". We'll list both basic and preferred as list items. Responsibilities: we have "Here’s What You’ll Do" bullet list. Also earlier paragraph describing role. Could combine into responsibilities. About the role: maybe we could have an About the role section summarizing the role description. But we already have responsibilities. The instruction: "Prefer a few substantive sections over many thin ones." So we could have sections: Responsibilities, Qualifications, Benefits, Schedule. Possibly also About the role if we have distinct content not covered elsewhere. The initial "The Role" paragraph is basically role summary; could be About the role. But we could incorporate that into Responsibilities. However to follow instruction, we could include About the role as a short paragraph summarizing the role. That seems okay. We must not repeat job title. No headings for Job ID. We must output only HTML fragment, no /, no markdown fences. Thus produce something like:

About the role

...

Responsibilities

• ...
...

Qualifications

• ...
...

Benefits

...

Schedule

100% onsite (required to be physically present for collaboration, mentorship, etc.)

We need to preserve all substantive information: ensure we don't lose details. Let's extract details. About the role: The Role paragraph: "In this role, you will serve as the Analytical Program Lead (APL) for a family of programs, accountable for all analytical activities required to support regulatory filings (e.g., IND and BLA/MAA) and early post-approval lifecycle activities. You will lead the definition and execution of program-level analytical strategies to enable successful clinical introduction, licensure. and transition to commercial manufacturing. You will be responsible for driving analytical readiness for clinical and registrational stage programs, including specification setting, analytical control strategy development, and comparability strategy design and execution (e.g., process changes, site transfers, lifecycle evolution), as well as generation of robust data packages to support global submissions. This role requires strong cross-functional leadership and the ability to ensure alignment across development, manufacturing, quality, and regulatory teams. This is an individual contributor role focused on program delivery, scientific rigor, and regulatory excellence. The role also plays an integral part in authoring and reviewing regulatory sections and responding to RTQs across programs." We'll keep that as paragraph. Responsibilities: "Here’s What You’ll Do" list: - Serve as the Analytical Program Lead for a family of programs, accountable for all analytical activities required to support regulatory filings (e.g., IND and BLA/MAA) and early lifecycle submissions. - Define and execute integrated analytical strategies, including specifications, analytical control strategy, comparability (process changes, site transfers, lifecycle), and assay lifecycle management. - Establish commercial specifications, control strategies, and comparability frameworks to enable initial licensure and post-approval changes. - Ensure analytical readiness for clinical studies and commercial manufacturing, including method qualification/validation, transfer, and control strategy implementation. - Lead and author analytical sections of regulatory filings (e.g., IND and BLA/MAA) and responses to health authority questions/RTQs, ensuring clarity, consistency, and regulatory defensibility. - Partner cross-functionally (QC, Regulatory CMC, MS&T, Manufacturing) to deliver robust, compliant, and inspection-ready analytical data packages. - Identify and mitigate analytical risks, including defining acceptance criteria and justification strategies aligned with global regulatory expectations. - Mentor team members and contribute to consistent, high-quality execution across programs. - Additional duties may be assigned from time to time. We'll keep all. Qualifications: Basic Qualifications: "Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field with 5+ years of relevant industry experience, or M.S./B.S. with 8+ years of experience in analytical development or quality control of biologics or vaccines." Preferred Qualifications: list: - Experience in analytical development for biologics or nucleic acid-based therapeutics, including experience with comparability strategy, study design, and regulatory justification. - Understanding of analytical control strategy, specification setting, and method lifecycle management for initial licensure. - Demonstrated experience authoring and reviewing analytical and CMC sections of BLAs/MAAs and responding to health authority queries. - Knowledge of ICH guidelines, GMP, and global regulatory expectations for late-phase development and commercial readiness. - Proven ability to translate complex analytical data into clear, concise, and defensible regulatory narratives. - Experience supporting technology transfer, method validation, and commercial site readiness. - Cross-functional collaboration skills with Regulatory, Quality, MS&T, and Manufacturing. - Ability to operate effectively in a fast-paced, matrixed environment with a high degree of accountability. - A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative. We'll combine into one list under Qualifications. Benefits: paragraph under "Pay & Benefits": "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 everywhere in between. 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 need to preserve that exactly but maybe fix spacing. We'll output as a single paragraph. Schedule: "Our Working Model" paragraph: "As we build our company, we have always believed that an in-person culture is critical to our success. This role is 100% onsite, reflecting the importance of being physically present to support the work, collaborate closely with colleagues, and contribute to our site-based operations. Working onsite enables real-time collaboration, strong team connections, direct mentorship, and the hands-on partnership needed to deliver our mission. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact." We'll keep that. We must not include boilerplate: Equal Opportunities, Accommodations, etc. Also remove "About Moderna" maybe not needed but could be considered boilerplate? It's about company description; not required headings. Could be omitted as not part of standard sections. The instruction: remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. "About Moderna" is not explicitly listed but could be considered boilerplate? It's not a standard heading; but we could keep if it's substantive. However we already have About the role; we could omit About Moderna to keep sections thin. The instruction: Prefer a few substantive sections over many thin ones. So we may omit About Moderna. Thus final HTML:

About the role

In this role, you will serve as the Analytical Program Lead (APL) for a family of programs, accountable for all analytical activities required to support regulatory filings (e.g., IND and BLA/MAA) and early post-approval lifecycle activities. You will lead the definition and execution of program-level analytical strategies to enable successful clinical introduction, licensure. and transition to commercial manufacturing. You will be responsible for driving analytical readiness for clinical and registrational stage programs, including specification setting, analytical control strategy development, and comparability strategy design and execution (e.g., process changes, site transfers, lifecycle evolution), as well as generation of robust data packages to support global submissions. This role requires strong cross-functional leadership and the ability to ensure alignment across development, manufacturing, quality, and regulatory teams. This is an individual contributor role focused on program delivery, scientific rigor, and regulatory excellence. The role also plays an integral part in authoring and reviewing regulatory sections and responding to RTQs across programs.

Responsibilities

• Serve as the Analytical Program Lead for a family of programs, accountable for all analytical activities required to support regulatory filings (e.g., IND and BLA/MAA) and early lifecycle submissions.
• Define and execute integrated analytical strategies, including specifications, analytical control strategy, comparability (process changes, site transfers, lifecycle), and assay lifecycle management.
• Establish commercial specifications, control strategies, and comparability frameworks to enable initial licensure and post-approval changes.
• Ensure analytical readiness for clinical studies and commercial manufacturing, including method qualification/validation, transfer, and control strategy implementation.
• Lead and author analytical sections of regulatory filings (e.g., IND and BLA/MAA) and responses to health authority questions/RTQs, ensuring clarity, consistency, and regulatory defensibility.
• Partner cross-functionally (QC, Regulatory CMC, MS&T, Manufacturing) to deliver robust, compliant, and inspection-ready analytical data packages.
• Identify and mitigate analytical risks, including defining acceptance criteria and justification strategies aligned with global regulatory expectations.
• Mentor team members and contribute to consistent, high-quality execution across programs.
• Additional duties may be assigned from time to time.

Qualifications

• Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field with 5+ years of relevant industry experience, or M.S./B.S. with 8+ years of experience in analytical development or quality control of biologics or vaccines.
• Experience in analytical development for biologics or nucleic acid-based therapeutics, including experience with comparability strategy, study design, and regulatory justification.
• Understanding of analytical control strategy, specification setting, and method lifecycle management for initial licensure.
• Demonstrated experience author