Associate Director-Small Molecule, Analytical Development

We need to output HTML fragment with sections: About the role (maybe heading "About the role"? Actually they said use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). The posting includes "About The Role" then "What You'll Do:" then bullet list of duties. Then "Who You Are" then bullet list of qualifications. Then "Where You'll Work" includes location and travel. Then "Pay Range" maybe? Actually they have "Pay Range" heading then "Life at Insmed" then benefits. So we need to include sections only if they have real specific content. We must not repeat job title as heading. No Job ID. Remove boilerplate like EEO, etc. Also remove application instructions (like "Current Insmed Employees: Please apply via the Jobs Hub in Workday." etc). Also remove legal statements. We need to preserve all substantive information. Let's extract content: - About The Role: description: "At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you?" This is generic company intro. Might be considered substantive? It's about company. Could be part of About the role? Might be considered fluff but it's part of posting. We'll keep as paragraph under About the role. - What You'll Do: list of duties (many bullet-like sentences). We'll put under

Responsibilities

maybe? They said use headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we can map: About the role (intro), Responsibilities (duties), Requirements/Qualifications (who you are), Skills maybe separate? But we can combine Requirements and Qualifications. They said prefer few substantive sections over many thin ones. So we could have About the role, Responsibilities, Qualifications (includes education, experience, skills), Benefits, Pay, Schedule? Pay Range is mentioned: "Pay Range" heading then "Life at Insmed". Actually they have "Pay Range" then "Life at Insmed". The Pay Range section likely contains nothing? Let's see: after "Where You'll Work" they have "Travel Requirements Minimal travel expected Pay Range Life at Insmed". It seems formatting messed. The text: "Travel Requirements Minimal travel expected Pay Range Life at Insmed At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it...." So there is no actual pay range numbers; just heading "Pay Range" then immediately "Life at Insmed". So Pay Range section has no specific content (no numbers). According to rule: never create Pay/Schedule/Benefits sections unless the posting actually states them. Since Pay Range heading exists but no actual range given, we should not create a Pay section because it lacks specific content. Similarly Benefits: they have "Life at Insmed" then bullet list of benefits. That is substantive benefits. So we should create Benefits section with that content. Schedule: they mention "full-time, in-person presence" and "Minimal travel expected". That's schedule info. Could be Schedule section. They said include schedule only if posting actually states them. It does state full-time, in-person presence, minimal travel. So we can create Schedule section with that. We also have Where You'll Work: location Bridgewater, NJ office, full-time in-person. That could be part of Schedule or maybe a separate "Location" but not in allowed headings. We could incorporate into Schedule or maybe a short paragraph under About the role? But we have Schedule heading for work schedule; we can include location and travel there. Now Benefits: list: Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP); Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration; 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance; Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities; Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back; Eligibility for specific programs may vary and is subject to the terms and conditions of each plan. We should keep that as

• items. Now Responsibilities: list of duties from "What You'll Do:" after colon. We'll extract each sentence as list item. Let's list them: - Develop and implement analytical strategies to support product development from preclinical and clinical stages through commercialization. - Provide technical leadership for analytical method development, optimization, qualification, validation, verification, and lifecycle management in accordance with ICH, FDA, EMA, and other global regulatory expectations. - Manage external analytical laboratories, CROs, CDMOs, and testing partners to ensure timely execution of analytical development activities, method transfers, validation studies, and stability testing. - Review and approve analytical protocols, reports, method validation documents, specifications, development reports, and technology transfer packages. - Provide analytical expertise and cross-functional support for nitrosamine and mutagenic impurity assessments, including strategy development, analytical testing, and regulatory support. - Serve as the analytical subject matter expert for characterization of drug substances, intermediates, excipients, and drug products, including impurity profiling, degradation pathways, extractables and leachables assessments, and stability-indicating methodologies. - Support formulation and process development activities through analytical troubleshooting, root cause investigations, and data-driven recommendations. - Lead analytical method transfer activities between development, manufacturing, and external testing laboratories to ensure successful execution and regulatory compliance. - Establish scientifically justified specifications and acceptance criteria for raw materials, drug substances, intermediates, and finished products throughout the product lifecycle. - Author, review, and provide analytical content for regulatory submissions, including INDs, IMPDs, NDAs, MAAs, and other global filings. - Support responses to regulatory agency questions and inspections. - Collaborate closely with Pharmaceutical Development, Quality Assurance, Regulatory Affairs, Supply Chain, Manufacturing, and Project Management teams to achieve program objectives and development timelines. - Ensure analytical activities are conducted in compliance with cGxP, ICH guidelines, USP/EP/JP requirements, and applicable regulatory standards. - Evaluate emerging analytical technologies and industry best practices to drive continuous improvement, operational efficiency, and scientific innovation. - Manage multiple analytical development programs simultaneously, identify technical and timeline risks, and develop effective mitigation strategies. - Interpret complex analytical data, provide scientific leadership for problem-solving efforts, and contribute to overall CMC strategy and product development decisions. Now Qualifications/Requirements: from "Who You Are". Let's parse: - You have a Bachelor’s degree along with 10 years of experience in specifically analytical development with at least 5 years roles involving oversight of external testing laboratories. - You are or you also have: Bachelor's degree in Chemistry, Biochemistry, or related discipline with 8+ years of experience in the pharmaceutical industry, specifically analytical development with at least 5 years roles involving oversight of external testing laboratories. - Hands-on expertise in analytical lab testing for inhalation dosage forms and other small molecule dosage forms. - Experience with inhalation and combination products is preferred. - Strong knowledge and experience in nitrosamine risk assessment, including identification, evaluation, and control of nitrosamine impurities. - Experience with mutagenic impurity assessment, including evaluation of potential genotoxic impurities and application of relevant regulatory guidance. - Proficient in regulatory requirements, including cGxP, CMC, ICH, and compendial standards (USP/EP/JP). - Excellent analytical and problem-solving skills, particularly in the context of technical troubleshooting and investigation management. - Effective communication skills, both verbal and written, including experience drafting regulatory responses and QC sections of submissions. - Strong organizational and project management skills, with a focus on timeliness, quality, and compliance. - Must embody the core values of Collaboration, Accountability, Passion, Respect, and Integrity, and demonstrate the ability to work in a diverse, dynamic environment. - Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace. We can combine into a list. Now Schedule: "This role is based out of our Bridgewater, NJ office and requires full-time, in-person presence to support hands-on collaboration, access specialized equipment, and/or operational needs. Travel Requirements Minimal travel expected". So schedule: full-time, in-person, location Bridgewater, NJ, minimal travel. We'll put under

  Schedule

  with a paragraph. Now Benefits: as above. Now About the role: we have the introductory paragraph. We'll put under

  About the role

  . We must not include headings with empty content. So we will have About the role, Responsibilities, Qualifications, Benefits, Schedule. Possibly also Skills? But we can incorporate skills into Qualifications. The instruction says prefer few substantive sections over many thin ones. So we can combine skills into Qualifications. Now ensure we don't include any boilerplate like EEO, legal, application instructions. We removed those. Now output HTML fragment only. Let's craft:

  About the role

  At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you?

  Responsibilities

  • Develop and implement analytical strategies to support product development from preclinical and clinical stages through commercialization.
  • Provide technical leadership for analytical method development, optimization, qualification, validation, verification, and lifecycle management in accordance with ICH, FDA, EMA, and other global regulatory expectations.
  • Manage external analytical laboratories, CROs, CDMOs, and testing partners to ensure timely execution of analytical development activities, method transfers, validation studies, and stability testing.
  • Review and approve analytical protocols, reports, method validation documents, specifications, development reports, and technology transfer packages.
  • Provide analytical expertise and cross-functional support for nitrosamine and mutagenic impurity assessments, including strategy development, analytical testing, and regulatory support.
  • Serve as the analytical subject matter expert for characterization of drug substances, intermediates, excipients, and drug products, including impurity profiling, degradation pathways, extractables and leachables assessments, and stability-indicating methodologies.
  • Support formulation and process development activities through analytical troubleshooting, root cause investigations, and data-driven recommendations.
  • Lead analytical method transfer activities between development, manufacturing, and external testing laboratories to ensure successful execution and regulatory compliance.
  • Establish scientifically justified specifications and acceptance criteria for raw materials, drug substances, intermediates, and finished products throughout the product lifecycle.
  • Author, review, and provide analytical content for regulatory submissions, including INDs, IMPDs, NDAs, MAAs, and other global filings.
  • Support responses to regulatory agency questions and inspections.
  • Collaborate closely with Pharmaceutical Development, Quality Assurance, Regulatory Affairs, Supply Chain