Jobs · Analyst · Indiana

Director - Dissolution Science & Biopharmaceutics

BioSpace · Indianapolis, IN · 4 wk ago
Analyst$149k–$257k/yrFull-time
We need to output HTML fragment with sections for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. Must not repeat job title. No Job ID etc. Remove boilerplate. Must preserve all substantive info. We need to parse the posting. Key content: - Intro paragraph about Lilly, purpose, etc. Could be "About the role"? Actually "About the role" could be description of role and organization. The posting includes description of SMDD organization, role description. So we can put that under

About the role

with paragraphs. - Responsibilities: list bullet points under "Responsibilities Core Technical Scope", "Strategic and Cross-Functional Leadership", "People Leadership and External Engagement". We'll combine into a
  • list. - Requirements: maybe "Basic Qualifications" is requirements. Also "Additional Skills/Preferences" could be Skills. Also "Additional Information" includes travel, location, etc. But we need to decide sections. We have Pay: "Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $148,500 - $257,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance)." So we have Pay section. Benefits: "In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)." Also mention Lilly reserves right to amend etc. That's benefits. Schedule: Not explicitly mentioned. There's travel 0-10%, location on-site. No schedule like full-time/part-time? It says Full-time equivalent employees also will be eligible for a company bonus. Implies full-time. But schedule not given explicitly. We should not create Schedule section unless posting actually states it. It does not state schedule like "Full-time" maybe implied but not explicit. Safer to omit Schedule. We also have "Additional Information Travel: 0 to 10% Position Location: On-site, Indianapolis, IN; Lilly Technology Center-North (LTC-N)". This could be part of "About the role" or separate? Could be included in a short paragraph under About the role or maybe a separate "Details" but we only have allowed headings. Could fold into About the role as a paragraph. We must not include boilerplate like EEO, accommodation request, ERGs, etc. Remove those. We must preserve all substantive information: that includes description of Lilly, SMDD, role, responsibilities, qualifications, additional skills/preferences, pay, benefits, travel, location. We must not invent or summarize away detail. Must keep specifics like dissolution methods, PBBM, etc. We need to use

    for section headings. Use
    • for any list of duties/requirements/benefits. Use

      for prose. We need to decide which content goes into which section. Possible sections: - About the role: includes intro about Lilly, SMDD organization, role description, travel, location. - Responsibilities: bullet list of responsibilities (core technical scope, strategic leadership, people leadership). - Requirements: Basic Qualifications (Ph.D etc). Could also include "Technical leadership experience..." etc. That's part of qualifications. - Skills: Additional Skills/Preferences (publication record, modeling platforms, formulation knowledge, influencing, mentoring). - Benefits: bullet list of benefits. - Pay: paragraph about compensation and bonus. We must not include sections with filler like "commensurate with experience". Not present. We must not repeat job title. We must not include Job ID/requisition numbers. Now craft HTML. We'll need to escape any special characters? Not needed. Let's draft. First, About the role: Paragraph(s): "At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us." Then description of SMDD organization and role: "The Synthetic Molecule Design and Development (SMDD) organization is responsible for the development of synthetic drug substances and drug products from the preclinical phase through commercialization. Our scientists and engineers develop innovative technical solutions to advance an exciting portfolio that includes small molecules, synthetic peptides, oligonucleotides, antibody-drug conjugates (ADCs) and other emerging therapeutic modalities. SMDD fosters a culturally diverse, high-performing workforce with deep technical expertise across these platforms. This is a technical leadership role that combines laboratory and modeling work with strategic influence across the product development lifecycle. You will have access to Lilly's world-class dissolution, biopharmaceutics modeling (PBBM), and analytical capabilities at the Lilly Technology Center in Indianapolis. SMDD is seeking a Director / Senior Director / Executive Director to lead the dissolution science and biopharmaceutics function for small molecule drug products, from early-phase development through commercialization. In this role, you will lead the product performance strategy on multidisciplinary project teams — developing and justifying dissolution methods, building biopharmaceutics risk assessments and biowaiver strategies, authoring CMC and biopharmaceutics regulatory content for global submissions and responses to health authority questions. In addition, you will drive the innovation agenda and contribute to Lilly’s external scientific presence in this area. The role includes management of a small team of 1–5 scientists and direct responsibility for multiple projects as well as technical oversight across a broader portfolio. You will work in close partnership with formulation, analytical, engineering, ADME, clinical pharmacology, and regulatory colleagues across Lilly Research Labs." Then travel and location: "Travel: 0 to 10%. Position Location: On-site, Indianapolis, IN; Lilly Technology Center-North (LTC-N)." We could combine into a paragraph. Now Responsibilities: list bullet points. We need to capture all responsibilities from the three subheadings. Let's extract bullet points: Core Technical Scope: - Develop, validate, and justify phase-appropriate dissolution methods that link in vitro drug product performance to in vivo behavior, spanning immediate-release and modified-release oral solid dosage forms. - Apply conventional and biorelevant/predictive dissolution as well as novel approaches to assess oral performance of drug molecules and formulations in humans. - Build and execute biopharmaceutics strategies using in vitro, in vivo, and in silico tools — including physiologically based biopharmaceutics modeling (PBBM) — to assess oral absorption, predict bridging risk, and establish clinically relevant specifications. - Author and defend dissolution and biopharmaceutics content in IND/CTAs, NDA/MAAs, and responses to health authority questions across global markets, including biowaiver justifications and IVIVC/IVIVR dossiers. Strategic and Cross-Functional Leadership: - Partner with formulation scientists, analytical chemists, engineers, clinical pharmacologists, and regulatory colleagues to define product performance control strategies — including specifications, dissolution method lifecycle management, and post-approval change strategies. - Support the design of new dosage forms and drug delivery technologies by applying pharmaceutical sciences knowledge spanning formulation, biopharmaceutics, pharmacokinetics, and patient-centered drug product design. - Plan and lead short-term and long-term dissolution and biopharmaceutics development activities across assigned programs and broader portfolio. - Develop technical agendas and timelines, recommend resource allocation, communicate progress, and propose changes in direction when warranted. People Leadership and External Engagement: - Directly lead a small team (1–5 scientists), providing technical mentorship, career development, and performance coaching. - Influence and engage the external scientific community through publications, conference presentations, and collaborations that advance Lilly’s dissolution science and biopharmaceutics capabilities. - Evaluate and integrate emerging science from adjacent disciplines (e.g., formulation science, PAT, modeling and simulation) into dissolution and biopharmaceutics practice. We'll put these as

      • items. Now Requirements: Basic Qualifications. We need to preserve all details. Basic Qualifications text: "Ph.D. in Pharmaceutical Sciences, Analytical Chemistry, Physical Chemistry, Chemical Engineering, or related discipline with 8+ years of pharmaceutical industry experience in drug product development and commercialization. (Will also consider M.S. with 12+ years or B.S. with 15+ years of directly relevant experience.) Technical leadership experience in dissolution science, biopharmaceutics, and product performance for small molecule drug products, with demonstrated ownership of deliverables from early development through regulatory submission, including hands-on experience with biorelevant dissolution testing, discriminating method development, and dissolution method lifecycle management across clinical and commercial phases. Track record of authoring CMC and biopharmaceutics regulatory sections (dissolution-related content in CTD Modules 3.2.P.2, 3.2.P.5, 2.7.1) and responding to health authority questions on product performance topics. Demonstrated experience applying PBBM to biowaivers, bridging risk assessments, clinically relevant dissolution method justification, or specification setting. Demonstrated knowledge of applicable CMC regulatory requirements (FDA, EMA, and other major health authorities) and emerging regulatory trends in dissolution and biopharmaceutics." We can format as paragraphs or list. Since it's a list of qualifications, we can use
        • . However the instruction says use
          • for any list of duties/requirements/benefits. So we should use list for requirements. Thus each bullet can be a qualification. We'll break into items: - Ph.D. in Pharmaceutical Sciences, Analytical Chemistry, Physical Chemistry, Chemical Engineering, or related discipline with 8+ years of pharmaceutical industry experience in drug product development and commercialization. (Will also consider M.S. with 12+ years or B.S. with 15+ years of directly relevant experience.) - Technical leadership experience in dissolution science, biopharmaceutics, and product performance for small molecule drug products, with demonstrated ownership of deliverables from early development through regulatory submission, including hands-on experience with biorelevant dissolution testing, discriminating method development, and dissolution method lifecycle management across clinical and commercial phases. - Track record of authoring CMC and biopharmaceutics regulatory sections (dissolution-related content in CTD Modules 3.2.P.2, 3.2.P.5, 2.7.1) and responding to health authority questions on product performance topics. - Demonstrated experience applying PBBM to biowaivers, bridging risk assessments, clinically relevant dissolution method justification, or specification setting. - Demonstrated knowledge of applicable CMC regulatory requirements (FDA, EMA, and other major health authorities) and emerging regulatory trends in dissolution and biopharmaceutics. Now Skills: Additional Skills/Preferences. List: - Strong publication record and external scientific engagement in dissolution science, biopharmaceutics, or related fields. - Proficiency with one or more biopharmaceutics modeling platforms (e.g., GastroPlus, Simcyp, DDDPlus, STELLA) and experience establishing IVIVC/IVIVR or bioequivalence safe spaces. - Knowledge of formulation development and physical pharmacy of small molecules, including poorly soluble compounds and enabling formulation technologies (e.g., amorphous solid dispersions, spray-dried intermediates). - Demonstrated ability to influence cross-functional alignment and negotiate technical decisions across formulation, analytical, engineering, ADME, clinical pharmacology, and regulatory functions. - Experience mentoring and developing technical talent at the scientist and senior scientist level. We'll use <

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