{"id":1704482,"url":"https://alion.io/job/contract-development-and-manufacturing-bora-pharmaceuticals-cdmo-principal-engineerscientist","title":"Principal Engineer/Scientist","company":{"id":2156158,"name":"Bora Pharmaceuticals","domain":"boracdmo.com","url":"https://alion.io/company/boracdmo","size_band":"1-10","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":79,"open_postings":6,"ghost_share":0,"stale_share":0.833,"repost_share":0,"time_to_fill_p50_days":35,"computed_at":"2026-10-31T05:58:55Z"}},"role":"Science & Research","role_family":"Science & Research","seniority":"lead","employment_type":"full_time","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":{"min":142000,"max":200000,"currency":"USD","period":"year","gross":null,"usd_annual":200000},"salary_estimate":null,"experience_years_min":14,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Bioreactors","optional":false},{"name":"Cell Culture","optional":false},{"name":"GMP","optional":false},{"name":"JMP","optional":false},{"name":"Machine Learning","optional":true}],"status":"live","first_seen_at":"2026-09-03T00:00:00Z","employer_posted_date":"2026-09-03","last_verified_at":"2026-10-31T18:23:29Z","board_verified":true,"closed_at":null,"days_open":59,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":59},"description":"About Bora:\nBora Biologics is a global biologics CDMO delivering integrated development and GMP manufacturing solutions from First-in-Human through licensed commercial supply. While many CDMOs are structured primarily for early clinical programs, Bora Biologics is purpose-built for commercialization. Our inspection-proven, bi-coastal U.S. manufacturing platform and integrated development center provide the infrastructure, regulatory discipline, and operational precision required for sustained global market supply.\nJob Summary:\nThe Principal Engineer, or Principal Scientist, at Cell Culture Sciences is a technical leader and hands-on expert responsible for mammalian cell culture and harvest bioprocess development, optimization, characterization, and validation across multiple client programs within a CDMO environment. This key team member is responsible for delivering robust, scalable, and regulatory-compliant processes to support diverse molecules from development through commercialization.\nThis role will lead the design and execution of studies, and interpretation of study results, develop control strategies, and apply data-driven approaches to enable efficient process development and technology transfer. This individual will partner cross-functionally with internal teams (other development function, Manufacturing, Supply Chain) and act as a key technical interface with clients, ensuring alignment on development strategies, timelines and deliverables. This role will also provide technical leadership in support of client programs, including preparing technical reports and regulatory documentation, contributing to proposals and study plans, to support client interactions.\nThis role will require a strong ability to manage multiple projects simultaneously, adapt to varying client needs, and drive scientific excellence while meeting timelines. The role will also manage team members and contribute to continuous improvement and innovation across the organization.\nEssential Functions:\nReasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.\nLeads, designs, and performs studies on cell culture and harvest unit operations for client programs, including process development, scale-up, toxicology material production, raw materials strategies, technology transfer. Supports development of clinical and commercial processes for a diverse portfolio of client molecules and modalities.\nLeads the technology transfer of cell culture and harvest processes to GMP manufacturing. Provides support to manufacturing throughout the product life cycle, including campaign monitoring, data analysis, equipment recommendations and regulatory support.\nPresents at internal, client-facing, and external meetings, effectively communicating technical information to audience.\nDevelops strategic goals and leads efforts for late-stage process development strategies, including the planning and execution of Process Characterization and small- and large-scale Process Validation studies.\nOversee the operation and maintenance of equipment and instrument; Implements best practices as part of robust process development strategy and technology transfer to manufacturing.\nProvides supervision to ensure all work is performed in a compliant manner and meets applicable regulatory guidelines. Continuously improves safety and lab procedures.\nPerforms all supervisory responsibilities for direct report(s). Provides coaching and mentoring to direct report(s). Foster a culture of accountability, responsiveness, and client focus\nServes as a resource for the department and project teams, proactively bringing updates on current scientific trends and technical aspects from conferences, local meetings, and literature.\nAdvances the development of lab technologies, procedures and equipment reliability to ensure experimental and process robustness at small and large scales and alignment with manufacturing capabilities.\nLeads Continuous Improvement initiatives to enhance efficiency, process scalability, and delivery to clients.\nThe above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.\nMinimum Education, Experience & Skills:\nMinimum Requirements\nEducation:\nPh.D. in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Biochemistry or related technical fields, and a minimum of 6 years of industry experience in mammalian cell culture and harvest process development of biologics,\nOr\nMasters’ degree in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Biochemistry processing or related technical fields and a minimum of 12 years of industry experience in areas described above,\nOr\nBachelors’ degree in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Biochemistry or related technical fields and a minimum of 14 years of industry experience in areas described above.\nExperience:\nSignificant hands-on experience in mammalian cell culture in fed-batch mode, with bench to intermediate scale-bioreactors, developing high-titer cell culture processes and process scale-up.\nHands-on experience in unit operations of harvest steps, including depth filtration and centrifugation.\nExperience in early- and late-stage cell culture process development activities and process characterization for cell culture unit operations.\nAt least 5 years’ experience in managing direct reports; coaching, mentoring and/or training team members.\nRequired Knowledge and Skills:\nKnowledge and in-depth understanding of mammalian cell culture, harvest, and bioprocess equipment as well as biochemical engineering principles. Comprehensive knowledge of mammalian protein expression and large-scale cell culture techniques as well as depth filtration.\nProven ability to solve technical and scientific problems.\nAbility to critically analyze data, question experimental results, perform root cause analysis, and to organize data and review technical reports.\nStrong understanding of statistical tools (such as JMP), DOE and QbD principles, with the ability to apply advanced statistical analysis and data-driven modeling to support process development and Process Characterization.\nStrong expertise in bioreactor scale-up principles, including scale-up/scale-down modeling and process comparability across scales.\nStrong organizational skills and ability to prioritize and execute multiple projects to completion\nAbility to set up, maintain, and troubleshoot equipment and drive implementation of new technologies and techniques for process development and commercial production\nStrong verbal, presentation and writing skills to communicate effectively internally and externally\nExperience in working in CMC teams.\nAbility to lead cross-functional teams, be collaborative, and represent the cell culture team and align stakeholders across internal functions and client organizations\nWillingness to work on weekends.\nSolid understanding of current FDA and ICH guidelines regarding cell culture/drug substance processes for biologics.\nPreferred Qualifications:\nExperience in cell culture in perfusion mode, including (N-1) perfusion.\nExperience in sizing depth filters for harvest operation.\nExperience in using acidification or coagulation for harvest.\nExperience in Cell Line Development, and knowledge in CHO cell functions.\nExperience in cell banks, and knowledge in relevant regulatory requirements.\nExperience applying advanced data analytics, such as mechanistic modeling, data visualization, predictive analytics, or machine learning approaches, to bioprocess development and process characterization.\nFamiliarity with data communication and SCADA systems.\nTrack record of authoring, planning, executing and reviewing both small- and large-scale Process Validation protocols, including LIVCA and EOPCB studies\nSalary Range:\n$142,000-$200,000\nCompensation and Benefits\nWe offer a comprehensive benefits package designed to support our employees’ wellbeing, including:\nCompetitive salary and performance-based incentives\n\nComprehensive health coverage including medical, dental, and vision insurance\n\nRetirement savings plans with employer matching contributions\n\nPaid time off\n\nProfessional development opportunities\n\nEmployee wellness programs and resources\n\nEmployee Assistance Program and Mental Health Resources\n\nCore Values\nAt Bora, our values guide everything we do - from how we solve challenges to how we support our people. We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone.\nBora Pharmaceuticals is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.","description_format":"text","description_chars":9665,"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":["Professional development","Retirement plans","Vision insurance","Wellness"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["CRO & CDMO Services","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-02T14:18:47Z"}],"visa":[],"liveness":{"score":22,"band":"cold","label":"Long shot","p_open":1,"p_active":0.478,"p_room":0.45,"age_days":58,"expected_fill_days":35,"reasons":["conf:1","win:tail"],"computed_at":"2026-10-31T05:58:55Z"},"pay":{"stated_usd_annual":200000,"is_top_pay":true},"html_url":"https://alion.io/job/contract-development-and-manufacturing-bora-pharmaceuticals-cdmo-principal-engineerscientist","json_url":"https://alion.io/job/contract-development-and-manufacturing-bora-pharmaceuticals-cdmo-principal-engineerscientist.json","meta":{"generated_at":"2026-11-01T03:17:23Z","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":5114,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-02T00:00:00Z"}},"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":2156158},"rest":"https://alion.io/mcp/rest/get_company?id=2156158"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcontract-development-and-manufacturing-bora-pharmaceuticals-cdmo-principal-engineerscientist"},{"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%2Fcontract-development-and-manufacturing-bora-pharmaceuticals-cdmo-principal-engineerscientist"},{"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%2Fcontract-development-and-manufacturing-bora-pharmaceuticals-cdmo-principal-engineerscientist"},{"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/contract-development-and-manufacturing-bora-pharmaceuticals-cdmo-principal-engineerscientist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcontract-development-and-manufacturing-bora-pharmaceuticals-cdmo-principal-engineerscientist"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":1704482}},{"tool":"search_jobs","arguments":{"company":"boracdmo.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":1704482},"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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