{"id":1292103,"url":"https://alion.io/job/terrestrial-senior-principal-scientist-analytical-method-development-lead","title":"Senior / Principal Scientist Analytical Method Development Lead","company":{"id":1988705,"name":"Terrestrial","domain":"terrestrialbio.com","url":"https://alion.io/company/terrestrialbio","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Ashby","truth_index":null},"role":"Science & Research","role_family":"Science & Research","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Woburn, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":67000,"max_usd":178000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":584},"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"HPLC","optional":false},{"name":"ICH Guidelines","optional":false},{"name":"Mass Spectrometry","optional":false}],"status":"live","first_seen_at":"2026-08-28T00:44:57Z","employer_posted_date":"2026-08-28","last_verified_at":"2026-10-22T02:02:48Z","board_verified":true,"closed_at":null,"days_open":55,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":55},"description":"Terrestrial Bio\nLocation: Allston, MA and Woburn, MA\nAbout Terrestrial Bio, Inc.\nTerrestrial is transforming the delivery of next-generation therapies, starting with GLP-1.\nTerrestrial's proprietary Tacterra™ microarray patch (MAP) and applicator platform consists of a patch resembling an adhesive bandage, which is applied with a preloaded applicator and removed after a few minutes. Once applied, each patch delivers bioactive tips into the skin, which dissolve quickly into the body, rapidly releasing their therapeutic payload. Designed for self-administration, the temperature-stable Tacterra™ platform enables precise, controlled delivery of a wide range of therapeutics without medical sharps or refrigeration.\nTerrestrial has generated strong clinical and in-vivo proof of concept across multiple molecules. For more information, visit www.terrestrialbio.com.\nWhy this role\nWe are seeking an Analytical Method Development (AMD) Lead to drive the analytical method development, qualification, and validation strategy for the microneedle array patch (MAP) program. This individual will lead the development of release and characterization methods including HPLC/UPLC, LC-MS, and functional assays and own the analytical method lifecycle from Phase 2 through Phase 3 IND and commercialization.\nThis is a senior technical leadership role for a scientist with deep peptide/biologic analytical expertise and a track record of building robust, regulatory-compliant methods.\nWhat you'll do\nLead analytical method development for release and characterization assays including RP-HPLC/UPLC purity, content, SEC, and impurity characterization by LC-MS.\n\nDefine and execute the analytical method validation strategy per ICH Q2(R2) and Q14.\n\nDevelop the Validation Master Plan (VMP) governing method qualification, validation, transfer, and lifecycle management.\n\nEstablish the impurity characterization strategy for GLP-1 peptide, including oxidation, deamidation, and related substances.\n\nLead method transfers to QC and to/from external CROs.\n\nDefine the analytical control strategy and specifications for Phase 2 Tox and Phase 3 clinical lots.\n\nSupport characterization of reference standards and establishment of bridging strategies.\n\nAuthor analytical sections of regulatory submissions (IND, CMC) and serve as analytical SME during inspections.\n\nGuide the development of the potency/functional assay strategy in collaboration with pre-clinical and formulation teams.\n\nMentor and develop method development scientists; provide technical leadership across the AMD function.\n\nWho you are\nPh.D. in Analytical Chemistry, Biochemistry, or related field with 6+ years relevant experience, OR M.S. with 8+ years in pharmaceutical/biotech analytical method development.\n\nDeep expertise in HPLC/UPLC method development for peptides or biologics.\n\nHands-on experience with LC-MS for impurity characterization and structural analysis.\n\nDemonstrated experience leading method validation under ICH Q2(R2)/Q14.\n\nExperience developing analytical control strategies and specifications for clinical-stage products.\n\nStrong knowledge of ICH Q6A, Q3A/B/C/D, and FDA/EMA CMC expectations.\n\nPreferred Qualifications\nExperience with GLP-1 peptides or semaglutide analytical methods.\n\nExperience with microneedle/transdermal or drug-device combination products.\n\nPrior experience defining potency or cell-based functional assay strategies.\n\nExperience supporting IND/BLA filings and regulatory interactions.\n\nExperience building and scaling an analytical method development function.\n\nKey Competencies\nDeep technical expertise combined with strategic program thinking.\n\nStrong leadership and mentoring capability.\n\nExcellent scientific writing and regulatory communication.\n\nAbility to balance scientific rigor with program timelines in a fast-paced environment.\n\nCompensation: The anticipated base salary range for this position is $125,000 - $180,000. Actual compensation will be determined based on a variety of factors including experience, qualifications, and internal equity.\nOnsite expectations: The majority of our roles at Terrestrial are either onsite or hybrid, which allows us to meet both business and team needs. Candidates applying must be willing to be onsite 4-5 days per week.\nLocation: Woburn, MA and our new, custom facility in Allston MA planned for Q4 of 2026.\nAt Terrestrial, we’re bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. We aim to recruit, employ, train, compensate and promote regardless of race, religion, color, national origin, sex, gender identity or expression, sexual orientation, disability, age, or veteran status.","description_format":"text","description_chars":4732,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"phd","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Vaccines","Cardiometabolic Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-26T08:06:31Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 4","filings_12m":4,"filings_prev_12m":2,"green_card_filings_12m":0,"median_offered_wage_usd":108750,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":24,"band":"cold","label":"Long shot","p_open":1,"p_active":0.523,"p_room":0.45,"age_days":54,"expected_fill_days":30,"reasons":["conf:2","win:tail"],"computed_at":"2026-10-21T05:46:15Z"},"pay":null,"html_url":"https://alion.io/job/terrestrial-senior-principal-scientist-analytical-method-development-lead","json_url":"https://alion.io/job/terrestrial-senior-principal-scientist-analytical-method-development-lead.json","meta":{"generated_at":"2026-10-22T02:59:18Z","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":2599,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-23T00:00:00Z"}},"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":1988705},"rest":"https://alion.io/mcp/rest/get_company?id=1988705"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fterrestrial-senior-principal-scientist-analytical-method-development-lead"},{"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%2Fterrestrial-senior-principal-scientist-analytical-method-development-lead"},{"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%2Fterrestrial-senior-principal-scientist-analytical-method-development-lead"},{"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/terrestrial-senior-principal-scientist-analytical-method-development-lead\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fterrestrial-senior-principal-scientist-analytical-method-development-lead"}]}