{"id":1661188,"url":"https://alion.io/job/proclinical-senior-director-api-development","title":"Senior Director API Development","company":{"id":2116512,"name":"Proclinical","domain":"proclinical.com","url":"https://alion.io/company/proclinical","size_band":"201-500","is_staffing_agency":true,"employer_type":"agency","is_intermediary":false,"listed_via":null,"ats_vendor":"Schema","truth_index":null},"role":"Leadership","role_family":"Leadership","seniority":"head","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Newark, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":250000,"max":280000,"currency":"USD","period":"year","gross":null,"usd_annual":280000},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-04T13:15:51Z","employer_posted_date":"2026-09-04","last_verified_at":"2026-10-05T21:54:32Z","board_verified":true,"closed_at":null,"days_open":31,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":31},"description":"Senior Director API Development's - Permanent - Newark, CA\nAre you an experienced API Development leader looking to shape the future of peptide-based medicines?\nProclinical is partnering with a highly successful, publicly listed biotechnology company that has recently achieved multiple major regulatory and commercial milestones, including FDA approvals for innovative peptide therapeutics and significant investment to accelerate the growth of its pipeline. Backed by a strong balance sheet, strategic partnerships with leading pharmaceutical companies, and a rapidly expanding portfolio, the organisation is entering an exciting new phase of growth and scientific innovation. As part of this expansion, we are seeking a Senior Director, API Development to lead process research, development, scale-up and manufacturing strategy for a portfolio of cutting-edge peptide therapeutics.\nPrimary Responsibilities:\nReporting into executive leadership, you will lead a multidisciplinary API Development function responsible for advancing peptide drug substances from early development through clinical and commercial manufacturing.\nYou will play a key role in defining scalable synthetic routes, overseeing technology transfer activities, managing external manufacturing partners, and developing robust supply strategies to support global clinical programmes.\nThis is a highly visible leadership position with significant influence across Discovery, Preclinical Development, Analytical Sciences, Toxicology, CMC, Regulatory Affairs and external CDMO partners.\nSkills &Requirements:\nPhD in Organic Chemistry, Process Chemistry or a related scientific discipline.\nSignificant pharmaceutical or biotechnology process development experience.\nDeep expertise in peptide API development and manufacturing.\nStrong hands-on knowledge of SPPS and LPPS technologies.\nExperience supporting IND, NDA, IMPD and other global regulatory submissions.\nDemonstrated leadership of internal teams and external CDMO networks.\nStrong understanding of FDA, EMA, ICH and cGMP requirements.\nProven ability to influence cross-functional stakeholders in a fast-paced development environment.\nThe Senior Director API Development's responsibilities will be:\nLead API process development activities for peptide therapeutics, non-canonical amino acids and small molecule components.\nDevelop phase-appropriate manufacturing routes using both solid-phase peptide synthesis (SPPS) and liquid-phase peptide synthesis (LPPS).\nDrive process optimisation, scale-up and technology transfer to global CDMO partners.\nEstablish manufacturing and supply strategies for raw materials, regulatory starting materials and drug substances.\nManage outsourced process development and manufacturing programmes.\nPartner closely with analytical development teams to understand impurity profiles and process performance.\nSupport regulatory submissions, CMC documentation and global health authority interactions.\nBuild, mentor and lead a high-performing API Development organisation.\nIdentify innovative technologies and manufacturing approaches to improve efficiency, quality and scalability.\nCompensation:\n$250,000 - $280,000 p/a + Benefits\nIf you are having difficulty in applying or if you have any questions, please contact Neil Walton \nIf you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.\nProclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.\nBy submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.proclinical.com/privacy-policy","description_format":"text","description_chars":3909,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"phd","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Natural Resources"],"lifecycle":[{"event":"open","at":"2026-10-02T03:48:38Z"}],"visa":[],"liveness":{"score":48,"band":"ok","label":"Likely open","p_open":1,"p_active":0.539,"p_room":0.9,"age_days":30,"expected_fill_days":45,"reasons":["conf:8","agency","velocity","win:mid"],"computed_at":"2026-10-05T05:45:15Z"},"pay":{"stated_usd_annual":280000,"is_top_pay":true},"html_url":"https://alion.io/job/proclinical-senior-director-api-development","json_url":"https://alion.io/job/proclinical-senior-director-api-development.json","meta":{"generated_at":"2026-10-06T00:42:45Z","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","counted_by":"address","units_charged":1,"used_today":897,"day_limit":5000,"remaining_today":4103,"minute_limit":60,"resets_at":"2026-10-07T00:00:00Z"}},"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":2116512},"rest":"https://alion.io/mcp/rest/get_company?id=2116512"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fproclinical-senior-director-api-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%2Fproclinical-senior-director-api-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%2Fproclinical-senior-director-api-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/proclinical-senior-director-api-development\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fproclinical-senior-director-api-development"}]}