{"id":2047589,"url":"https://alion.io/job/cordenpharma-director-analytical-research-development","title":"Director, Analytical Research & Development","company":{"id":2014421,"name":"CordenPharma","domain":"cordenpharma.com","url":"https://alion.io/company/cordenpharma","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"ADP","truth_index":{"grade":"A","score":90,"open_postings":5,"ghost_share":0,"stale_share":0.2,"repost_share":0,"time_to_fill_p50_days":61,"computed_at":"2026-10-19T05:45:15Z"}},"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":["Boulder, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":195000,"max":215000,"currency":"USD","period":"year","gross":null,"usd_annual":215000},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-07T18:34:00Z","employer_posted_date":"2026-10-07","last_verified_at":"2026-10-19T18:52:19Z","board_verified":true,"closed_at":null,"days_open":12,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":12},"description":"CordenPharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical and biotech companies manufacture medicines with the ultimate goal of improving people’s lives.\nOur network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being.\nOur People Vision\nWe strive for excellence. We share our passion. Together, we make a difference in patients' lives.\nSUMMARY\nResponsibilities include setting and achieving objectives consistent with site strategy, analytical method development and validation for peptides small molecules APIs. Developing and monitoring plans to meet outlined objectives, building employee capabilities consistent with site needs, and embedding continuous improvement in our day-to-day activities.\nProvides strategic Analytical Technical leadership and management for the Analytical R&D Department at the Corden Pharma Colorado site. Leads the design, development, and validation of analytical methods supporting peptide programs.\nProvides Analytical R&D leadership to drive high performing Development teams, effective cross-collaboration with other departments, and inspires confidence in site’s technical capabilities.\nEnsures that standard work and tactical plans for Analytical Development activities are organized and results are achieved, consistent with customer expectations and site objectives. The Analytical R&D Department is responsible for technical support of plant operations that include developing or transferring new analytical methods to support early phase clinical GMP programs, as well as validating analytical methods for late phase commercial products.\nThis position requires a hands-on expertise managing large teams in a CDMO environment, with deep analytical technical knowledge of peptides and peptide related products, and expertise in various analytical techniques from HPLC, UPLC, SEC, LCMS/MS, CHN, AAA, IC, ICPMS, KF, IR, Raman, etc.\nDrives best practices through active participation across site R&D Development strategy and plan.\nMember of the Development organization’s Leadership Team responsible for sustainable profitable growth.\nESSENTIAL DUTIES AND RESPONSIBILITIES\nInclude the following. Other duties may be assigned.\nResponsible for Technical and managerial leadership of Analytical R&D’s project portfolio. Provide scientific and operational leadership and ensure Analytical R&D meets customer expectations on budget and on time for the technical aspect of the projects; including IPC method development, release methods, starting materials and regulatory starting materials testing\nResponsible for Analytical Chemistry method development and phase appropriate validation\nResponsible for technical evaluation of new projects, including identification of risks, innovation opportunities, capabilities needed, cost analysis, and pricing strategy\nDevise and execute long-term analytical strategies that are aligned with programs commercialization and regulatory timelines\nProvide written and verbal communication to customers to ensure confidence in ability to deliver on projects. Participate in customer meetings providing strategic direction to cross functional teams\nLead development, tech transfer and qualification, and validation of stability indicating methods, by looking at accuracy, precision, specificity, robustness, intermediate precision, and stability\nReview and approve validation protocols and analytical method validation reports\n Oversee external partners supporting validation or external testings on behalf of CordenPharma\nEnsure Analytical R&D capabilities align with strategic goals and provide competitive advantage. Ensure the proper technical resources and skills are in place and appropriately applied to meet and exceed Development goals. Provide access to external technical sources and contacts, as needed to assure leading state of science and technology\nServe as Analytical Technical Lead for Peptide Development Programs, setting CMC direction for these compounds, evaluating efficient analytical comparability strategies culminating in successful tech transfers and validation execution\nIdentify technical, business, and interpersonal skill development needs of the members of the management team; and recommend appropriate training, either formal or on the job, and ensure training is effective\nGuide and review strategic technical work of group members as necessary to ensure a high-quality work product on technical and quality issues\nParticipates in developing the Corden Pharma brand\nResponsible for ensuring compliance with GMP, regulatory, safety, and environmental regulations and laws for local, state, and federal\nLEADERSHIP & BUDGET RESPONSIBILITIES\nProvides direct leadership to functional managers and their direct reports. Carries out leadership responsibilities in accordance with the policies and applicable laws.\nResponsibilities include interviewing, hiring, and training employees; is the principal decision maker in recruiting and hiring; and in making salary recommendations for the members of the department; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; and addressing complaints and resolving problems.\nResponsible for developing, managing the budget for the Analytical R&D Department, and ensuring expenses are within the budget.\nContributes to the direction and oversight of the operational aspects of the organization by serving on the Development site Leadership Team. Be a key point of contact for high level customer interactions and joint steering committees.\nSAFETY & ENVIRONMENTAL RESPONSIBILITIES\nEvery individual is personally responsible for the safety and environmental aspects of their activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.\nQUALITY RESPONSIBILITIES\nCorden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products. In following Current Good Manufacturing Practices (cGMP), Corden Pharma Colorado manufactures in accordance with the US Food and Drug Administration (FDA), International Council for Harmonisation Q7 (ICH), and other global regulations as applicable. This is critical as it is our mission to not place patients at risk due to inadequate safety, quality, or efficacy. CPC’s Quality Management System, which incorporates cGMP, is designed to deliver this quality objective. Attainment is produced through the requisite participation and commitment of all staff across departments and at all levels within the company.\ncGMP is the part of Quality Management System ensuring products are consistently produced to accurate quality standards. Adherence to clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado.\nQUALIFICATIONS\nTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.\nEDUCATION and/or EXPERIENCE\nDoctoral Degree (PhD) or equivalent in Chemistry, Analytical Chemistry, or related field with 15 years of experience in the development of API, particularly with a focus on Peptide APIs; or equivalent combination of education and experience. Experience developing CMC strategies and successfully executing on ICH Compliant methods development and validation.\nLANGUAGE SKILLS\nAbility to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, scientific and public groups, as well as to boards of directors.\nMATHEMATICAL SKILLS\nAbility to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.\nREASONING ABILITY\nAbility to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with multiple abstract and concrete variables.\nCERTIFICATES, LICENSES, REGISTRATIONS\nMust be able to travel both domestically and internationally.\nPHYSICAL DEMANDS\nThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.\nWhile performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to sit. The employee is occasionally required to stand; walk; and work with hands. The employee must occasionally lift and/or move up to 25 pounds.\nWORK ENVIRONMENT\nThe work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.\nThe noise level is typical of an office environment.\nCORE COMPETENCIES\nThese are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.\nUnderstanding of basic science and engineering associated with the manufacture of pharmaceuticals\nDemonstrated expertise in Analytical Development and Operations Management. Well versed with QbD approach, and all ICH regulatory guidances and framework\nDemonstrated expertise and know-how in peptide synthesis both on solid phase and in solution phase. Well versed with various techniques to characterize peptide APIs of 10-50Aas\nProven experience leading and managing high performing analytical teams\nProject Management skills, planning, staffing, organizing, directing, and controlling\nAnalytical problem-solving skills\nWorking knowledge of regulatory issues in pharmaceutical manufacturing\nLeadership and negotiation skills\nAbility to build relationships, influence, and motivate others\nCoaching and mentoring skills. Strong communication skills\nExcellent written and oral communication skills and presentation skills\nExperience with international environments\nSALARY\nActual pay will be based on your skills and experience.\nBENEFITS\n401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service \nAccident Plan\nCritical Illness Insurance\nDental Insurance\nDisability Insurance\nEmployee Assistance Program\nFlexible Spending Account\nHealth Insurance PPO/HSA\nHospital Indemnity Plan\nID Theft Protection\nLife Insurance\nPaid Parental Leave\nTuition Reimbursement\nWellness Program\nVacation - Three Weeks 1st Year\nVision Insurance\nEQUAL OPPORTUNITY EMPLOYER\nCorden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and...","description_format":"text","description_chars":12353,"description_truncated":true,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"phd","optional":true},"security_clearance":false,"languages":[]},"benefits":["Dental insurance","Health insurance","Life insurance","Parental leave","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Internet Service Providers","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-07T20:29:12Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":11,"expected_fill_days":61,"reasons":["conf:2","win:early"],"computed_at":"2026-10-19T05:45:15Z"},"pay":{"stated_usd_annual":215000,"is_top_pay":false},"html_url":"https://alion.io/job/cordenpharma-director-analytical-research-development","json_url":"https://alion.io/job/cordenpharma-director-analytical-research-development.json","meta":{"generated_at":"2026-10-19T19:51:17Z","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":15696,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-20T00:00:00Z"}},"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":2014421},"rest":"https://alion.io/mcp/rest/get_company?id=2014421"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcordenpharma-director-analytical-research-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%2Fcordenpharma-director-analytical-research-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%2Fcordenpharma-director-analytical-research-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/cordenpharma-director-analytical-research-development\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcordenpharma-director-analytical-research-development"}]}