{"id":1549537,"url":"https://alion.io/job/ptcbio-senior-scientist-analytical-development","title":"Senior Scientist, Analytical Development","company":{"id":2004095,"name":"PTC Therapeutics","domain":"ptcbio.com","url":"https://alion.io/company/ptcbio","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Bridgewater Township, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":139900,"max":176100,"currency":"USD","period":"year","gross":null,"usd_annual":176100},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Chromatography","optional":false},{"name":"GMP","optional":false},{"name":"HPLC","optional":false},{"name":"Mass Spectrometry","optional":false},{"name":"LIMS","optional":true},{"name":"Microsoft Office","optional":true}],"status":"live","first_seen_at":"2026-09-21T00:00:00Z","employer_posted_date":"2026-09-21","last_verified_at":"2026-10-22T11:20:35Z","board_verified":true,"closed_at":null,"days_open":32,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":32},"description":"PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease.\nAt PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.\nVisit our website to learn more about our company and culture!\nSite: www.ptcbio.com\nJob Description Summary:\nThe Senior Scientist, Analytical Development supports and contributes to PTC’s analytical development function for early stage and late-stage development projects. The incumbent develops, implements, validates, transfers and troubleshoots a variety of analytical methods (e.g. Chromatographic methods) used for in-process evaluation, releases of Active Pharmaceutical Ingredients (API), and bulk and final drug products at Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs/CDMOs). He/she also provides analytical support for clinical formulation development.The incumbent works cross-functionally with internal departments and external resources on analytical development related issues.\nThe Senior Scientist, Analytical Development supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.\n.\nJob Description:\nESSENTIAL FUNCTIONS\nPrimary duties/responsibilities:\nConducts analytical method development for New Chemical Entities (NCEs) and drug products using chromatography and other analytical techniques.\nCoordinates development of analytical and control tests for API, starting materials, process intermediates and drug product at PTC and at CMOs; provides oversight and direction for analytical method transfer and validation at external CMOs.\nCoordinates requirements and acquisition of analytical documentation/data/reports needed to support, or to be included in, submissions to Investigational New Drug applications (INDs), New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), amendments, supplements, and annual reports; authors and reviews regulatory documents and responses.\nPerform investigations and unknown impurity identifications in in-house lab using High Pressure Liquid Chromatography (HPLC), Liquid Chromatography/Mass Spectrometry (LC/MS) and Gas Chromatography/Mass Spectrometry (GC/MS).\nAssists in providing oversight for all stability related work at CROs/CMOs/CDMOs.\nRepresents department as a subject matter expert (SME) in relevant analytical areas, as needed.\nComplies data from internal and external sources and provides data summaries to management.\nConducts a second analyst review of analytical data and work, as needed.\nProvides analytical support to early and late stage discovery programs, as needed. \nCoordinates analytical development related activities within the company and external contractors as needed.\nPurchases required lab supplies, maintains instruments, purchases, installs, qualifies laboratory instrumentation.\nPerforms other tasks and assignments as needed and specified by management. \nKNOWLEDGE/SKILLS/ABILITIES REQUIRED\n* Minimum level of education and years of relevant work experience.\nMaster’s degree in a Chemistry, Biochemistry or Pharmacy related discipline and a minimum of 5+ years of analytical development experience in a pharmaceutical, biotechnology or other related industries OR a PhD in a Chemistry, Biochemistry or Pharmacy related discipline and a minimum of 4+ years of analytical development experience in a pharmaceutical, biotechnology or other related industries.\n* Special knowledge or skills needed and/or licenses or certificates required.\nExtensive experience in the development, validation, and implementation of analytical Standard Operating Procedures (SOPs) that employ a range of analytical methods (e.g., High Pressure Liquid Chromatography (HPLC), Liquid Chromatography/Mass Spectrometry (LC/MS), Gas Chromatography/Mass Spectrometry (GC/MS), dissolution, particle size, moisture content, etc.).\nHands-on experience with the identification, sourcing, and maintenance of analytical instruments.\nDemonstrated experience in troubleshooting of analytical methods.\nWorking knowledge of US and international Chemistry, Manufacturing and Control (CMC) regulations and guidance, including Good Manufacturing Practice (GMP), the US Code of Federal Regulations (21CFR) and International Conference of Harmonization (ICH) guidelines is desirable.\nWorking knowledge of Laboratory Information Management Systems (LIMS) and Chromatographic data systems (e.g. Empower®).\nManagement of reference standards for internal and external needs, as necessary.\nExperience reviewing analytical data (at release and stability).\nExperience with designing and executing forced degradation studies for NCEs.\nHands-on experience collaborating with the Formulations and Medicinal Chemistry groups in developing analytical methods such as HPLC-UV for early phase formulation development.\nProficiency with Microsoft Office.\nExcellent verbal and written communication and skills.\nAbility to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.\nAnalytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. \nExcellent planning, organization and time management skills including the ability to manage, support and prioritize multiple projects. \n*Special knowledge or skills and/or licenses or certificates preferred.\nExperience using electronic lab notebook. \nTrack record of authorship of pertinent sections of successful regulatory submissions (INDs, NDAs, Abbreviated New Drug Applications (ANDAs), MAAs, Investigational Medicinal Product Dossiers (IMPDs)) leading to the commercialization of drug products. \nExperience providing responses to questions from health authorities with respect to regulatory submissions. \nExperience with statistical data analysis.\n* Travel requirements\n 0-10%\n*Physical requirements\n Office /Laboratory based position\nExpected Base Salary Range: $139,900 - $176,100. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.\nIn addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC’s medical, dental, vision, and retirement savings plans.\nEEO Statement:\nPTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.\nClick here to return to the careers page","description_format":"text","description_chars":7185,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"master","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity","Retirement plans"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Cell & Gene Therapy","Rare Disease Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-30T23:49:22Z"}],"visa":[],"liveness":{"score":24,"band":"cold","label":"Long shot","p_open":1,"p_active":0.699,"p_room":0.35,"age_days":32,"expected_fill_days":15,"reasons":["conf:18","win:tail"],"computed_at":"2026-10-23T05:54:15Z"},"pay":{"stated_usd_annual":176100,"is_top_pay":false},"html_url":"https://alion.io/job/ptcbio-senior-scientist-analytical-development","json_url":"https://alion.io/job/ptcbio-senior-scientist-analytical-development.json","meta":{"generated_at":"2026-10-23T11:29:38Z","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":17403,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-24T00:00:00Z"}},"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":2004095},"rest":"https://alion.io/mcp/rest/get_company?id=2004095"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fptcbio-senior-scientist-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%2Fptcbio-senior-scientist-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%2Fptcbio-senior-scientist-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/ptcbio-senior-scientist-analytical-development\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fptcbio-senior-scientist-analytical-development"}]}