{"id":1814953,"url":"https://alion.io/job/probio-cdmo-cmc-lead-biologics-sme","title":"CMC Lead, Biologics SME","company":{"id":2125529,"name":"ProBio CDMO","domain":"probiocdmo.com","url":"https://alion.io/company/probiocdmo","size_band":null,"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":"lead","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":110000,"max_usd":209000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":100},"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-09-17T03:25:46Z","employer_posted_date":"2026-10-02","last_verified_at":"2026-11-05T04:22:50Z","board_verified":true,"closed_at":null,"days_open":49,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":49},"description":"ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017.\nJob Description:\nThe incumbent will lead the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical teams and business development team. The incumbent will also participate in business development activities such as visiting existing or new clients and promoting Probio’s services at conferences/trade shows.\nKey Responsibilities:\nProvide technical and project support to BD during pre-sales activities, including client presentations, technical discussions, and solution development to improve opportunity-to-order conversion.\nServe as the CMC technical lead/SME for biologics programs, providing technical guidance across cell line development, process development, GMP manufacturing, and related CMC activities.\nCollaborate with CMC functional teams and Project Management to ensure successful project execution, timely delivery, and alignment with client expectations.\nLead technical discussions with clients and ensure alignment on project scope, strategy, timelines, technical requirements, and deliverables.\nReview and provide technical input on proposals, project plans, and client-facing documentation.\nServe as Project Leader for selected integrated CMC projects from U.S. clients.\nSupport client visits, conferences, and other business development activities by representing ProBio’s technical capabilities and service offerings.\nQualifications:\nPh.D. in Biopharmaceutical Sciences or a related field with 3+ years of relevant industry experience, or a master’s degree with 7+ years of relevant industry experience.\nStrong experience in biologics CMC, including areas such as cell line development, process development, GMP manufacturing, and regulatory support.\nDemonstrated track record supporting IND and/or BLA programs for antibody and protein biologics.\nStrong client-facing communication and presentation skills, with the ability to translate complex technical information into clear recommendations.\nDemonstrated ability to collaborate effectively across BD, Project Management, Manufacturing, and other technical functions.\nStrong leadership, problem-solving, and project management skills.\nCommercial mindset with the ability to understand customer needs and support business growth.\nExcellent written and verbal communication skills in English.\nBenefits:\nBenefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.\nProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.\nProBio Inc. maintains a drug-free workplace.\nPlease note: ProBio Inc. will only contact candidates through verified application sources. Probio does not request personal information from candidates through individual email or any other platform.","description_format":"text","description_chars":4674,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"master","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":["Parental leave","Retirement plans","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biologics & Biosimilars","CRO & CDMO Services"],"lifecycle":[{"event":"open","at":"2026-10-03T23:38:26Z"}],"visa":[],"liveness":{"score":61,"band":"ok","label":"Likely open","p_open":1,"p_active":0.813,"p_room":0.75,"age_days":48,"expected_fill_days":68,"reasons":["conf:1","win:late"],"computed_at":"2026-11-04T06:34:25Z"},"pay":null,"html_url":"https://alion.io/job/probio-cdmo-cmc-lead-biologics-sme","json_url":"https://alion.io/job/probio-cdmo-cmc-lead-biologics-sme.json","meta":{"generated_at":"2026-11-05T05:24:35Z","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":6455,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-06T00:00:00Z"}},"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":2125529},"rest":"https://alion.io/mcp/rest/get_company?id=2125529"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fprobio-cdmo-cmc-lead-biologics-sme"},{"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%2Fprobio-cdmo-cmc-lead-biologics-sme"},{"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%2Fprobio-cdmo-cmc-lead-biologics-sme"},{"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/probio-cdmo-cmc-lead-biologics-sme\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fprobio-cdmo-cmc-lead-biologics-sme"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":1814953}},{"tool":"search_jobs","arguments":{"company":"probiocdmo.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":1814953},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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