{"id":3198647,"url":"https://alion.io/job/alkermes-principal-engineer-process-development-osd","title":"Principal Engineer, Process Development - OSD","company":{"id":1780712,"name":"Alkermes","domain":"alkermes.com","url":"https://alion.io/company/alkermes","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Oracle","truth_index":{"grade":"B","score":75,"open_postings":8,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-25T05:49:26Z"}},"role":"Backend","role_family":"Backend","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":["Waltham, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":173000,"max":193000,"currency":"USD","period":"year","gross":null,"usd_annual":193000},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Design of Experiments","optional":false}],"status":"live","first_seen_at":"2026-07-30T13:48:29Z","employer_posted_date":"2026-07-30","last_verified_at":"2026-10-25T10:44:47Z","board_verified":true,"closed_at":null,"days_open":87,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":87},"description":"Join the Alkermes Process Development team as a Principal Engineer, where you will lead late-stage drug product Process Development activities at internal and external manufacturing sites. You will be responsible for providing technical guidance and driving execution for small molecule process development, scale-up and technical transfer to manufacturing from Phase 3 up to PPQ. You will play a key role in the CMC team and work closely with the Operations organization. This role will thrive in a highly collaborative matrix team environment to drive critical decision-making and ensure the successful development of new drugs.\n Provide subject matter expertise in process development methodologies at Alkermes requiring internal/external execution and technical oversight/supervision.\nGuide and drive process development, design of experiments, product characterization and control strategy development for development programs.\nDesign and execute process development activities suitable for progressive stages of small molecule pharmaceutical development that follow ICH and FDA guidance.\nWork closely with colleagues across Pharmaceutical Development and Manufacturing organizations to best leverage internal and/or external capabilities to assist in process development effort.\nProvide timely technical support and management oversight of process development activities at external partners.\nDevelop, review, and approve process development source documents, and author and review drug product process development sections for regulatory submissions.\nPresent technical data to cross functional teams and senior management as a process development expert, and effectively communicate critical process issues and solutions.\nIdentify and advocate new and emerging technology opportunities for process development.\nManage, train and mentor junior Process Development staff.\nPerform other duties as assigned.\n PhD (>8 years’ experience) or MS (>15 years’ experience) in Science or Engineering \nExpertise and demonstrated experience in small molecule process development, scale up and technical transfer.\nExpertise in design of experiments, data analysis and data interpretation for process development studies.\nExperience managing contract drug development (CDMO) activities.\nTechnical problem-solving ability utilizing current research and technologies.\nBroad understanding of the drug development process and the role and impact of process development within this process \nDemonstrated collaborative leadership, strong people skills, and excellent verbal and written communication skills.\nExpert understanding of ICH, FDA, and USP guidelines and the ability to apply these guidelines in context of the stage of drug development.\nSubject matter proficiency across a range of processing techniques such as, powder blending granulation, compression, encapsulation, Wurster coating and pan coating.\nDemonstrated ability to work successfully in a fast-paced team/matrix environment as well as independently manage priorities and maintain timelines for multiple activities.\nPrevious experience with Process Analytical Technology is preferred.\nTravel Requirements\nTravel demands will vary based on project stage and business needs; however, travel will be a key component of this role. The successful candidate is expected to serve as a primary technical representative during critical manufacturing activities and provide onsite leadership at development and commercial manufacturing sites during scale-up campaigns, technology transfers, validation activities, process troubleshooting, and other key project milestones as needed.\nThe annual base salary for this position ranges from $173,000 to $193,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here","description_format":"text","description_chars":4003,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"master","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Biologics & Biosimilars","Psychiatric Care"],"lifecycle":[{"event":"open","at":"2026-10-24T06:46:48Z"}],"visa":[],"liveness":{"score":16,"band":"cold","label":"Long shot","p_open":1,"p_active":0.581,"p_room":0.28,"age_days":86,"expected_fill_days":23,"reasons":["conf:8","win:tail","crowd:"],"computed_at":"2026-10-25T05:49:26Z"},"pay":{"stated_usd_annual":193000,"is_top_pay":false},"html_url":"https://alion.io/job/alkermes-principal-engineer-process-development-osd","json_url":"https://alion.io/job/alkermes-principal-engineer-process-development-osd.json","meta":{"generated_at":"2026-10-25T15:56:22Z","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":22963,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-26T00:00:00Z"}},"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":1780712},"rest":"https://alion.io/mcp/rest/get_company?id=1780712"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Falkermes-principal-engineer-process-development-osd"},{"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%2Falkermes-principal-engineer-process-development-osd"},{"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%2Falkermes-principal-engineer-process-development-osd"},{"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/alkermes-principal-engineer-process-development-osd\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Falkermes-principal-engineer-process-development-osd"}]}