{"id":590988,"url":"https://alion.io/job/amgen-director-process-development-drug-substance","title":"Director, Process Development - Drug Substance","company":{"id":4775,"name":"Amgen","domain":"amgen.com","url":"https://alion.io/company/amgen","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":85,"open_postings":346,"ghost_share":0,"stale_share":0.575,"repost_share":0.014,"time_to_fill_p50_days":43,"computed_at":"2026-11-03T05:54:40Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","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":["Hyderabad, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":27000,"max_usd":64000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":841},"experience_years_min":14,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Agile","optional":true},{"name":"GMP","optional":true},{"name":"Machine Learning","optional":true}],"status":"live","first_seen_at":"2026-09-10T11:15:57Z","employer_posted_date":"2026-09-10","last_verified_at":"2026-11-03T09:00:52Z","board_verified":true,"closed_at":null,"days_open":54,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":54},"description":"Career Category\nProcess DevelopmentJob Description\nJoin Amgen’s Mission of Serving Patients\nAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.\nSince 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.\nOur award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.\nWhat you will do\nLet’s do this. Let’s change the world. In this vital role you will lead a diverse team within our Process Development organization, maintaining accountability for its daily operations with a focus on Drug Substance Technologies (DST). You will build a new team, creating the capabilities, operating model, and cross-site partnerships needed to advance drug substance deliverables for Amgen products. You will ensure a high level of quality in the work performed. You will partner with key internal stakeholders to build this new organization, define the required capabilities, and resource it with a team of qualified personnel who have the education, experience, and training needed to perform the work in alignment with Amgen values.\nAs Director, Process Development, you will report to the Executive Director, Process Development and:\nReport dotted line to DST leadership, leading a team at AIN that is focused on advancing drug substance deliverables for all Amgen products\n\nWork with functional partners within AIN as well as other Amgen sites and teams to define roles and responsibilities, hire and build new teams and implement new processes\n\nBuild and lead a new DST team at AIN with capabilities across technical documentation, regulatory authoring and support, data analytics, automation/digital tools, and process monitoring\n\nCreation of strong communication channels with existing DST teams across the Amgen sites to establish and drive knowledge sharing, learning and networking\n\nWork with cross-functional teams to establish and improve digital tools as voice of customer\n\nManage the team for Drug Substance Technologies at AIN to ensure timely completion of goals and objectives\n\nSet project timelines and priorities for key initiatives and/or team activities\n\nLead and develop the team, providing staff member supervision and on-going coaching\n\nStrategically plan, analyze, and manage resources to include budget, contractors, staff, etc.\n\nAct upon performance metrics and process issues, implementing actions to drive continuous improvement and escalation to management if needed\n\nPartner to establish the operating model, governance, and engagement framework for the AIN DST team in partnership with DST leadership and AIN site stakeholders\n\nTranslate business, technical, and regulatory needs into team capabilities, priorities, and execution plans\n\nWhat we expect of you\nWe are all different, yet we all use our unique contributions to serve patients.\nBasic Qualifications:\nDoctorate degree and 8 years of drug substance biotech experience OR\nMaster’s degree and 15 years of drug substance biotech experience OR\nBachelor’s degree and 20 years of drug substance biotech experience AND\n4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources\nPreferred Qualifications:\n14+ years of drug substance process development or manufacturing experience in biotech or pharmaceutical industry\n\nAdvanced Degree in Biochemistry, Biochemical Engineering, Chemical Engineering, or related discipline\n\nKnowledge of cGMP regulations (FDA, EMEA, Health Canada)\n\nWorking knowledge of applicable drug substance manufacturing/ testing processes (process development, process validation, commercial manufacturing)\n\nExperience applying automation, artificial intelligence, machine learning, or large language model-enabled tools in a compliant enterprise environment.\n\nKnowledge of statistics, data analytics tools and methods\n\nKnowledge of project management tools and Agile methodologies\n\nStrong leadership skills with the ability to build new teams and implement new processes\n\nDemonstrated ability leading and coaching cross-functional teams, consistently deliver on-time, and with high-quality results\n\nStrong verbal and written communication. Ability to communicate effectively with Senior and Executive Leadership, including communicating level of risk, urgency, or impact to the business\n\nAbility to operate in an international matrix or team environment with site, functional, and executive leadership\n\nAbility to flex working hours to maximize interactions with global teams\n\nWhat you can expect of us\nAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.\nIn addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.\nApply now for a career that defies imagination\nObjects in your future are closer than they appear. Join us.\ncareers.amgen.com\nAs an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.\nAmgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.\n.","description_format":"text","description_chars":6377,"description_truncated":false,"requirements":{"experience_years_min":14,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Prescription Drugs","Immunology & Inflammation Therapeutics","Cardiometabolic Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-10T11:15:57Z"}],"visa":[],"liveness":{"score":27,"band":"fade","label":"Fading","p_open":1,"p_active":0.607,"p_room":0.44,"age_days":53,"expected_fill_days":43,"reasons":["conf:2","stale_co","velocity","win:tail","crowd:brand"],"computed_at":"2026-11-03T05:54:40Z"},"pay":null,"html_url":"https://alion.io/job/amgen-director-process-development-drug-substance","json_url":"https://alion.io/job/amgen-director-process-development-drug-substance.json","meta":{"generated_at":"2026-11-03T11:46:16Z","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":16050,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-04T00:00:00Z"}},"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":4775},"rest":"https://alion.io/mcp/rest/get_company?id=4775"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Famgen-director-process-development-drug-substance"},{"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%2Famgen-director-process-development-drug-substance"},{"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%2Famgen-director-process-development-drug-substance"},{"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/amgen-director-process-development-drug-substance\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Famgen-director-process-development-drug-substance"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":590988}},{"tool":"search_jobs","arguments":{"company":"amgen.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":590988},"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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