{"id":1003968,"url":"https://alion.io/job/element-seniorprincipal-scientist-bioseparation-analytical-development","title":"Senior/Principal Scientist – Bioseparation & Analytical Development","company":{"id":6204,"name":"Element","domain":"element.com","url":"https://alion.io/company/element","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"iCIMS","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"lead","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Ann Arbor, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":67000,"max_usd":179000,"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":[],"status":"live","first_seen_at":"2026-09-17T14:22:01Z","employer_posted_date":"2026-09-21","last_verified_at":"2026-10-25T23:29:27Z","board_verified":true,"closed_at":null,"days_open":38,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":38},"description":"Overview\nElement Ann Arbor is currently seeking a highly experienced Senior or Principal Scientist - Bioseparation to lead and execute advanced analytical method development, characterization, and validation of large molecule therapeutics across discovery, development, and late-stage CMC. This is an onsite, laboratory-based role with significant hands-on responsibility in bioseparation sciences, supporting a broad range of biologics modalities including proteins and recombinant proteins, peptides and peptide-drug conjugates, monoclonal antibodies (mAbs) and biosimilars, antibody-drug conjugates (ADCs), mRNA therapeutics, DNA constructs (including plasmid DNA and oligonucleotides), viral vectors, and other complex or emerging modalities such as fusion proteins, multispecifics, and engineered biologics.\nResponsibilities\nLead development, optimization, and troubleshooting of bioseparation-based analytical methods supporting biologics across discovery, development, and late-stage CMC, including orthogonal analytical strategies for comprehensive characterization\nPerform hands-on execution and technical leadership across a broad range of modalities, including proteins and recombinant proteins, peptides and peptide-drug conjugates, monoclonal antibodies (mAbs) and biosimilars, antibody-drug conjugates (ADCs), mRNA therapeutics, DNA/plasmid DNA/oligonucleotides, viral vectors, and emerging complex biologics (fusion proteins, multispecifics, engineered constructs)\nApply deep expertise in chromatography platforms (HPLC/UPLC/UHPLC, SEC, IEX, HIC, RP-HPLC, affinity chromatography), mass spectrometry (LC-MS/MS, high-resolution MS, SEC-MALS, native MS, MAM workflows, glycan/PTM characterization), capillary electrophoresis (CE-SDS, cIEF, purity/identity assays), and supporting biophysical techniques (DLS, DSC, UV/fluorescence, MALS, CD, FTIR)\nLead analytical strategy for complex biologics programs, including method development, qualification, validation, transfer, comparability, stability, forced degradation, and full characterization studies\nEnsure development of robust GMP-compliant methods aligned with ICH Q2/Q6, USP, EP, and GMP requirements, and support regulatory submissions (IND, BLA, IMPD) with high-quality analytical data packages\nDrive innovation in analytical science, including implementation of MAM workflows, high-throughput LC-MS platforms, automated bioseparation methods, and evaluation of emerging technologies in biologics characterization\nProvide scientific leadership and mentorship to junior scientists, including troubleshooting complex bioseparation and mass spectrometry challenges and establishing best practices in analytical development and execution\nSkills / Qualifications\nBS in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field required; Master's degree or higher preferred, but not required.\nExtensive industry experience in biologics analytical development is highly desirable\n8-15+ years of experience in biopharmaceutical or CRO analytical development with strong hands-on expertise in bioseparation of large molecules\nDeep technical expertise across analytical platforms, including LC/UPLC/SEC/IEX/HIC/RP chromatography, LC-MS and high-resolution mass spectrometry, CE-SDS, cIEF, SEC-MALS, and complementary biophysical techniquesStrong scientific knowledge of protein structure and higher-order structure, monoclonal antibodies and biosimilars, antibody-drug conjugates (ADCs), engineered biologics, and nucleic acid-based therapeutics (mRNA, DNA, oligonucleotides)\nDemonstrated experience in comparability, stability studies, and degradation pathway analysis for complex biologics\nPreferred experience includes CRO or client-facing analytical project execution, MAM workflows, advanced LC-MS analytics, glycan mapping and PTM quantification, and automation/high-throughput analytical systems\nStrong scientific writing capability with experience supporting regulatory documentation and submissions\nProven ability to execute in onsite laboratory environments with strong hands-on bioseparation and multi-platform analytical integration skills\nAbility to manage complex biologics programs in fast-paced, matrixed environments with strong problem-solving and scientific reasoning capabilities\nEffective communicator across scientific, regulatory, and operational stakeholders\nPhysical Demands:\nFrequency of required physical force: Minimum (moderate)\nLifting requirements: lifting 50 lbs. on occasion\nAbility to stand on feet for long periods of time\nAbility to lift 50+lbs periodically\nCompany Overview\nElement is one of the fastest growing testing, inspection and certification businesses in the world. Globally we have more than 9,000 brilliant minds operating from 270 sites across 30 countries. Together we share an ambitious purpose to ‘Make tomorrow safer than today’.\nWhen failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access.\nWhile we are proud of our global reach, working at Element feels like being part of a smaller company. We empower you to take charge of your career, and reward excellence and integrity with growth and development.\nIndustries across the world depend on our care, attention to detail and the absolute accuracy of our work. The role we have to play in creating a safer world is much bigger than our organization.\nDiversity Statement\nAt Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming “the world’s most trusted testing partner”.\nAll suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws.","description_format":"text","description_chars":6383,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"master","optional":true},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Engineering Services","Testing, Inspection & Certification"],"lifecycle":[{"event":"open","at":"2026-09-17T14:22:01Z"}],"visa":[],"liveness":{"score":19,"band":"cold","label":"Long shot","p_open":1,"p_active":0.554,"p_room":0.35,"age_days":37,"expected_fill_days":12,"reasons":["conf:1","win:tail"],"computed_at":"2026-10-25T05:49:26Z"},"pay":null,"html_url":"https://alion.io/job/element-seniorprincipal-scientist-bioseparation-analytical-development","json_url":"https://alion.io/job/element-seniorprincipal-scientist-bioseparation-analytical-development.json","meta":{"generated_at":"2026-10-26T01:07:08Z","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":1450,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-27T00:00:00Z"}},"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":6204},"rest":"https://alion.io/mcp/rest/get_company?id=6204"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Felement-seniorprincipal-scientist-bioseparation-analytical-development"},{"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%2Felement-seniorprincipal-scientist-bioseparation-analytical-development"},{"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%2Felement-seniorprincipal-scientist-bioseparation-analytical-development"},{"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/element-seniorprincipal-scientist-bioseparation-analytical-development\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Felement-seniorprincipal-scientist-bioseparation-analytical-development"}]}