{"id":3027959,"url":"https://alion.io/job/kailera-director-analytical-development-and-quality-control","title":"Director, Analytical Development and Quality Control","company":{"id":678636,"name":"Kailera","domain":"kailera.com","url":"https://alion.io/company/kailera","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":[],"countries":[],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":192000,"max":235000,"currency":"USD","period":"year","gross":null,"usd_annual":235000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"GMP","optional":false},{"name":"HPLC","optional":false},{"name":"Mass Spectrometry","optional":false}],"status":"live","first_seen_at":"2026-10-20T15:32:55Z","employer_posted_date":"2026-10-20","last_verified_at":"2026-10-25T14:12:20Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.\nWe are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.\nWhat You’ll Do:\nThe Director, Analytical Development and Quality Control will provide strategic and technical leadership for the analytical development, qualification, validation, and lifecycle management of analytical methods, and overall analytical control strategy supporting the development and commercialization of sterile parenteral drug products, in support of Kailera’s pipeline. This role is responsible for leading all activities to enable successful regulatory submissions, approval, and product launch.\nThe successful candidate will bring progressive experience in pharmaceutical or biopharmaceutical analytical development, including demonstrated experience supporting an NDA for a parenteral drug product. The role requires a strong understanding of analytical chemistry, method development and validation, drug product characterization, stability programs, specifications, and regulatory CMC requirements, together with the ability to translate complex analytical data into sound technical and regulatory strategies.\nThe Director will work cross-functionally with other Technical Operations functions, Quality Control, Quality Assurance, Regulatory Affairs, Manufacturing, and external contract development and manufacturing organizations (CDMOs) and contract testing laboratories. This leader will establish analytical strategies, oversee external laboratory execution, ensure scientific and regulatory rigor, and drive analytical readiness to support clinical and regulatory milestones, NDA approval, and commercial supply.\nRequired location: Waltham, MA (hub-based, onsite 3-4 days per week) OR Remote (home-based, onsite at a hub 1 week every other month).\nResponsibilities:\nLead analytical development, control strategy, and lifecycle management for sterile injectable/parenteral products from development through commercialization, including method development, validation, transfer, QC implementation, and commercial support.\nDefine and execute analytical CMC strategies, regulatory submissions, and control frameworks, including NDA Module 3 content, analytical data packages, specifications, characterization, validation, stability, and commercial release requirements.\nEnsure scientifically sound, regulatory-compliant analytical programs by leading technical issue resolution, risk management, resource planning, agency interactions, and compliance with FDA, ICH, and pharmacopeial expectations.\nProvide analytical leadership for product characterization, stability, microbiological strategies, quality attributes, commercial manufacturing support, and investigations related to analytical trends, deviations, and product quality issues.\nEstablish and maintain robust analytical methods through risk-based qualification, validation, lifecycle management, continuous improvement, troubleshooting, performance monitoring, revalidation, and enhancement of method robustness and efficiency.\nLead stability and specification strategies across the product lifecycle, ensuring analytical data support shelf life, storage conditions, regulatory commitments, product release, and commercialization objectives.\nIntegrate analytical, formulation, process, and manufacturing knowledge to support technology transfer, comparability assessments, change management, and oversight of external analytical laboratories and partners.\nRequired Qualifications:\n10+ years of experience, or 8+ with advanced degree, in the pharmaceutical/biotech industry with experience in all phases of innovative drug development and commercial launch in accordance with global CMC regulatory filings (IND/NDA/MAA, etc.)\nStrong expertise in analytical techniques HPLC/UPLC, LC-MS, SE-HPLC, CCIT, device testing, etc.\nKnowledge of drug development activities with respect to cGMP, quality systems, ICH guidelines, global regulatory requirements, and USP, EP, JP, and CHP requirements\nStrong track record of working with CROs/CMOs and managing external analytical development and QC activities\nDemonstrated leadership ability with experience mentoring and developing staff\nStrong communication, cross-functional collaboration, and project-management skills\nInnovative team-player with high energy for our dynamic company environment\nPreferred Qualifications:\nPrior experience supporting development of peptide sterile injectable/combination drug products\nExperience supporting commercial products\nKnowledge of combination product testing and control strategy is a plus\nEducation:\nA bachelor’s degree with 10+ years or an advanced degree with 8+ years of relevant experience\nDegree in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or closely related field\nSalary Range\n$192,000—$235,000 USD\nFor Full Time Roles: This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants-because your well-being and future matter to us.\nEQUAL EMPLOYMENT OPPORTUNITY INFORMATION: \nKailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.\nE-Verify:\nKailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.\n #LI-Hybrid","description_format":"text","description_chars":6866,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity","Flexible time off","Life insurance"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Cardiometabolic Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-21T19:37:38Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":4,"expected_fill_days":50,"reasons":["conf:3","win:early"],"computed_at":"2026-10-25T05:49:26Z"},"pay":{"stated_usd_annual":235000,"is_top_pay":false},"html_url":"https://alion.io/job/kailera-director-analytical-development-and-quality-control","json_url":"https://alion.io/job/kailera-director-analytical-development-and-quality-control.json","meta":{"generated_at":"2026-10-25T15:32:15Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":22509,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-26T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":678636},"rest":"https://alion.io/mcp/rest/get_company?id=678636"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fkailera-director-analytical-development-and-quality-control"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fkailera-director-analytical-development-and-quality-control"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fkailera-director-analytical-development-and-quality-control"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/kailera-director-analytical-development-and-quality-control\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fkailera-director-analytical-development-and-quality-control"}]}