Associate Director, CMC Product Development

We need to output HTML fragment with sections: About the role? Actually the posting includes "About Beeline Medicines" then "Job Summary". We need headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Use

for each section heading. Only include sections that have real specific content. We must not repeat job title as heading. Must not include Job ID etc. Must preserve all substantive info. Remove boilerplate like EEO, privacy, etc. Also remove application instructions. We need to parse content. Sections: - About the role: Could be "Job Summary" maybe. The posting includes "Job Summary" describing role. So we can put that under

About the role

with paragraph(s). Or maybe "About the role" is appropriate. - Responsibilities: The "Essential Duties And Responsibilities" list. Use

• . - Requirements: Possibly "Qualifications" section includes education, experience, etc. Could be "Requirements". We'll put qualifications under

  Requirements

  with paragraphs and maybe list. - Skills: Could be extracted from qualifications: "Deep expertise...", "Experience authoring...", "Proven ability...", "Skilled in managing external partner relationships...", "Strong written and verbal communication skills...", "Effective collaborator...", "Organized and detail-oriented communicator...". Could be separate

  Skills

  with list. - Benefits: The posting includes "Benefits" section with description. So include

  Benefits

  with paragraph(s) and maybe list. - Pay: The posting includes "Salary Range" with a range $197,905 - $210,514USD and note about varies by location. Also mentions discretionary bonus and long-term incentive. So we can include Pay section with that info. - Schedule: The posting includes "Work Arrangement & Location: Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as Tuesday and Wednesday. Additional on-site days may be required based on business needs, team priorities, or leadership direction." So schedule section. We must not include sections with filler like "commensurate with experience". Not needed. We must not repeat job title. Not include Job ID. We must not include boilerplate like EEO, privacy, reasonable accommodation, etc. Remove those. We must preserve all substantive information. So we need to include all details from the posting except those removed. Let's extract substantive info: About Beeline Medicines: description of company. Should we include? The instruction: "About the role" heading. Could include company description as part of about the role? Probably yes. The "About Beeline Medicines" is substantive. We'll include that under About the role. Job Summary: description of role. Essential Duties And Responsibilities: list. Qualifications: education, experience, etc. Skills: we can extract from qualifications but maybe we can combine qualifications and skills? The instruction says prefer few substantive sections over many thin ones. Could combine Qualifications and Skills into one section? But they ask to use headings for those categories if content exists. We have content for both. Could keep both. But we need to avoid thin sections. Qualifications has several bullet-like sentences; Skills also many. Might be okay. We need to ensure we don't invent or summarize away detail. Must preserve all substantive info. So we need to include each piece. Let's list all substantive pieces: Company description: "Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully." Job Summary: "The Associate Director, CMC Product Development – Small Molecule is a senior pharmaceutical scientist and individual contributor responsible for formulation development, drug product process development, and manufacture of clinical supplies in support of small molecule drug candidates. Reporting to the Executive Director, CMC Product Development, this individual is the primary technical owner for drug product development activities on assigned programs, driving work from early formulation screening through Phase 3 and registration. This role carries no direct reports but serves as the key scientific interface with CDMO drug product partners and cross-functional CMC teams. It requires hands-on expertise in small molecule formulation science and manufacturing, direct CDMO technical management experience, and the ability to deliver high-quality CMC outcomes independently in a pre-commercial biotech environment." Work Arrangement & Location (Schedule): "Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as Tuesday and Wednesday. Additional on-site days may be required based on business needs, team priorities, or leadership direction." Essential Duties And Responsibilities (list): - Lead formulation development activities for small molecule drug candidates across all clinical phases, including excipient screening, compatibility studies, formulation optimization, and selection of final drug product composition for clinical and commercial manufacturing. - Oversee drug product process development and scale-up for solid oral dosage forms (tablets, capsules) and other small molecule delivery formats, including process characterization, manufacturing process optimization, and tech transfer to CDMO sites. - Serve as the primary technical interface with CDMO drug product teams for assigned programs, providing day-to-day scientific oversight of formulation and manufacturing campaigns, batch record review, and deviation resolution. - Author and contribute to drug product sections of regulatory submissions (IND, IMPD, NDA) including formulation descriptions, manufacturing process narratives, container-closure justifications, and drug product control strategies. - Integrate Quality by Design (QbD) principles and Design of Experiments (DoE) into formulation and process development decisions, establishing critical quality attributes (CQAs), critical process parameters (CPPs), and design spaces. - Oversee drug product stability programs in collaboration with Analytical Development, including protocol design, shelf-life determination, and stability data interpretation in support of regulatory submissions and label claims. - Support packaging development and container-closure system selection for clinical drug product presentations, including compatibility assessment, extractables/leachable considerations, and child-resistant packaging requirements. - Contribute to clinical supply planning by providing manufacturing timelines, batch size projections, and drug product release schedules to the Clinical Supply Chain function in support of trial startup and enrollment milestones. - Evaluate drug delivery technology options and novel dosage form strategies for pipeline candidates, providing formulation feasibility assessments and manufacturability input during candidate selection and early development planning. - Operate as a self-directed pharmaceutical sciences contributor — independently managing formulation study plans, CDMO deliverable timelines, and CMC documentation while keeping cross-functional teams and leadership aligned on program status, risks, and decisions. Qualifications (list): - Perform other duties and responsibilities as assigned (maybe not needed? It's a generic line; could be considered boilerplate? It's a generic statement; maybe we should keep? It's part of qualifications but it's generic. Might be considered filler? It says "Perform other duties and responsibilities as assigned". That's typical boilerplate; but it's part of the qualifications section. The instruction: remove duplicated lines, but not necessarily generic statements. However it's not substantive detail; it's a placeholder. Might be considered filler. I'd consider removing it as it's not specific. But we need to preserve ALL substantive information; this line is not substantive. So we can drop it. - Education: Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, or a closely related discipline preferred, or equivalent industry experience in pharmaceutical analytical development. - 7+ years of pharmaceutical drug product development experience focused on small molecules in pharmaceutical or biotechnology industry - Demonstrated track record of serving as the primary scientific lead on formulation and drug product process development programs across multiple clinical phases. - Deep expertise in solid oral dosage form development (immediate release, modified release, amorphous dispersions), including excipient selection, compatibility, and manufacturing process development for tablets and capsules. - Experience authoring drug product sections of INDs, IMPDs, and NDA filings and contributing to FDA or EMA responses on formulation, manufacturing, and drug product control strategy topics. - Proven ability to operate as a high-impact individual contributor in a pre-commercial, resource-constrained environment — executing against multiple program deliverables simultaneously, operating with scientific independence, and contributing to the build-out of functional infrastructure and processes. - Skilled in managing external partner relationships including CDMOs and contract laboratories, with hands-on experience in technical oversight, work order management, change control, deviation resolution, and performance monitoring at the working level. - Strong written and verbal communication skills, with the ability to clearly present scientific data, development recommendations, and program updates to senior leadership and cross-functional partners. - Effective collaborator with a track record of building productive working relationships across CMC functions, Clinical Development, Regulatory Affairs, and Quality in a team-oriented environment. - Organized and detail-oriented communicator who can manage competing priorities, proactively flag risks, and keep cross-functional stakeholders aligned on timelines and deliverable status. Skills: Could be derived from qualifications but we might combine. However we have many skill-like statements. Could create Skills section with bullet list of skills: formulation development, drug product process development, CDMO technical management, QbD, DoE, regulatory submissions, stability programs, packaging development, clinical supply planning, drug delivery tech evaluation, self-directed contributor, communication, collaboration, organization. But we must not invent or summarize away detail. If we create Skills section, we need to ensure we are not losing any detail; we can just copy the skill statements from qualifications into Skills section. However that would duplicate content. The instruction: "Prefer a few substantive sections over many thin ones." So maybe better to combine Qualifications and Skills into one section called "Qualifications & Skills". But they ask to use headings for each of those categories if content exists. However they didn't forbid combining; they said use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we could have both Qualifications and Skills sections, but we need to avoid thin sections. Qualifications section already has many bullet points; Skills could be thin if we extract only a few. But we could put all skill statements under Skills and move education/experience under Qualifications. That would make two substantive sections. Let's do: Qualifications: education, years experience, track record, deep expertise, experience authoring sections, proven ability to operate as high-impact individual contributor. Skills: managing external partner relationships, communication skills, collaborator, organized/detail-oriented, etc. Also maybe include formulation development etc? But those are more qualifications. However we can split arbitrarily as long as we preserve all info. Better: Qualifications: education, years experience, track record, deep expertise, experience authoring sections, proven ability to operate as high-impact individual contributor. Skills: skilled in managing external partner relationships, strong written and verbal communication skills, effective collaborator, organized and detail-oriented communicator. But we also have "Operate as a self-directed pharmaceutical sciences contributor — independently managing formulation study plans, CDMO deliverable timelines, and CMC documentation while keeping cross-functional teams and leadership aligned on program status, risks, and decisions." That's more of a skill/responsibility. Could go under Skills. We'll decide. Now Benefits: The posting includes: "We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to: Competitive health and wellness coverage (structure and premiums vary by country) Paid time off, public holidays, and additional leave entitlements in accordance with local requirements Flexible work arrangements / hybrid schedule Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your