Scientist, Analytical Development, Small Molecule
- ):
- Ensure all testing is performed in compliance with GMP regulations and internal standard operating procedures (SOPs).
- Accurately recording and reporting test results, maintaining detailed and compliant documentation in accordance with GMP.
- Validate analytical methods using advanced techniques (e.g., HPLC, UPLC, GC, XRPD, Raman, PSD, FTIR, Dissolution and more) to support drug substance and drug product characterization.
- Work closely with formulation scientists, process development teams, and regulatory groups to support CMC activities, ensuring analytical methods meet the necessary regulatory standards.
- Lead pre-formulation and stability studies for small molecule drug products to assess their shelf life and ensure product quality during development and commercialization.
- Analyze complex data, identify potential issues in analytical methods or product quality, and propose scientifically sound solutions to overcome technical challenges.
- Prepare technical documents such as protocols, development reports, validation reports, and regulatory submissions, ensuring they are compliant with cGMP and regulatory requirements.
- Contribute to regulatory filings (IND, NDA), including providing the necessary analytical data and documentation required for submissions to global health authorities.
- Ensure all analytical activities comply with cGxP, ICH guidelines, and regulatory standards for the pharmaceutical industry, including USP/EP/JP requirements.
- Interpret complex data to solve challenging problems and provide scientific direction within the AR&D laboratory.
Note: Some bullet start with verb forms not parallel; but we keep as is.
Who You Are paragraph:
"You have a Bachelor’s degree along with five years of experience in Chemistry. You are or you also have: Hands-on expertise in analytical lab testing for inhalation dosage forms, solid oral and liquid dosage forms. Experience with inhalation and combination products is preferred. Proficient in regulatory requirements, including cGxP, CMC, ICH, and compendial standards (USP/EP/JP). Ability to conduct risk assessments and develop analytical methods for the detection and control of nitrosamine impurities, ensuring compliance with regulatory guidelines. Strong commitment to laboratory work with meticulous attention to detail. Advanced proficiency in Microsoft Office tools. Excited to contribute to a fast-paced, team-oriented environment focused on accelerating early-stage drug development. 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 split: Requirements (education/experience) and Qualifications (specific expertise) and Skills (maybe the rest). But we need to avoid duplication.
Let's define:
- Requirements: Bachelor’s degree + five years of experience in Chemistry.
- Qualifications: Hands-on expertise in analytical lab testing for inhalation dosage forms, solid oral and liquid dosage forms; Experience with inhalation and combination products preferred; Proficient in regulatory requirements, including cGxP, CMC, ICH, and compendial standards (USP/EP/JP); Ability to conduct risk assessments and develop analytical methods for detection and control of nitrosamine impurities; Strong commitment to laboratory work with meticulous attention to detail; Advanced proficiency in Microsoft Office tools; Excited to contribute to fast-paced team-oriented environment; Must embody core values Collaboration, Accountability, Passion, Respect, Integrity; Ability to work in diverse dynamic environment; Ability to interact successfully in dynamic culturally diverse workplace.
- Skills: maybe the same as qualifications; but we could treat qualifications as skills. However we need separate sections only if there is distinct content. Could combine Qualifications and Skills into one? But instruction: prefer a few substantive sections over many thin ones. So we could have Requirements and Qualifications (which includes skills). But they also ask for Skills section. Might be okay to have Requirements, Qualifications, Skills each with content.
We need to ensure not to repeat same info across sections.
Let's extract:
Requirements: Bachelor’s degree + five years experience in Chemistry.
Qualifications: Hands-on expertise in analytical lab testing for inhalation dosage forms, solid oral and liquid dosage forms; Experience with inhalation and combination products preferred; Proficient in regulatory requirements, including cGxP, CMC, ICH, and compendial standards (USP/EP/JP); Ability to conduct risk assessments and develop analytical methods for detection and control of nitrosamine impurities; Strong commitment to laboratory work with meticulous attention to detail; Advanced proficiency in Microsoft Office tools.
Skills: Excited to contribute to a fast-paced, team-oriented environment focused on accelerating early-stage drug development; 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.
That seems distinct enough.
Now Where You'll Work:
"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"
We can put under Schedule (or maybe a separate Work Location section but not in list). Since Schedule heading is allowed, we can put full-time, in-person, minimal travel.
Pay: "$127,000.00-165,500.00 Annual"
Benefits: Life at Insmed paragraph with bullet list.
Let's extract benefits:
"Highlights Of Our U.S. Offerings Include 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 can turn into bullet list.
Now we must remove boilerplate: The rest like "At Insmed, every moment..." introductory paragraph maybe considered About the company but not required heading; we could include as part of About the role? But it's not about the role; it's generic company description. The instruction says preserve ALL substantive information; do NOT invent or summarize away detail. So we should keep that introductory paragraph? It's about company mission, recognition, etc. It's substantive but not under any of the allowed headings. However we could incorporate it into About the role section? The instruction: Use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings, but says use those for section headings. It says "include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text". It doesn't forbid other headings, but we should stick to those headings for sections. The introductory paragraph could be placed before any heading as plain
. That's allowed: output only HTML fragment, can have paragraphs and headings. So we can keep the introductory paragraph as a
before the first heading. Similarly, "At Insmed, you’ll find a culture..." is part of Benefits section; we already captured. We must remove EEO, legal, application instructions, etc. So after benefits we should stop before those paragraphs. Let's construct HTML. We'll start with an introductory paragraph: "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?" That's substantive. Then
About the role
... (the About The Role paragraph)
ThenResponsibilities
- ... each bullet
Requirements
Bachelor’s degree along with five years of experience in Chemistry.
ThenQualifications
- ... list items
Skills
- ... list items
Benefits
- ... benefits items
Pay
$127,000.00-165,500.00 Annual
ThenSchedule
Based out of Bridgewater, NJ office; full-time, in-person presence required; minimal travel expected.
We need to ensure we didn't miss any substantive info: The "While experience with inhalation products