Director, Analytical Research – Development

Corden Pharma - A Full-Service CDMO

. Set and achieve objectives consistent with site strategy .

Posted 10/8/2026full-timeBoulder • Colorado • United StatesLead💰 $195,000 - $215,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Analytical Method Development and Validation for Peptide APIs, with a strong focus on ICH Compliant methods and regulatory requirements. Proven leadership in managing high-performing teams and driving strategic initiatives within Analytical R&D.

Highest-signal resume keywords

PhD In Chemistry Or Analytical ChemistryAnalytical Method Development And ValidationHPLC, UPLC, SEC, LCMS/MSAnalytical Development And Operations ManagementProject Management Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Analytical Method DevelopmentValidation ProtocolsPeptide SynthesisStatistical TechniquesAnalytical Problem-Solving

Soft Skills

LeadershipCommunication SkillsRelationship-BuildingCoachingNegotiation

Tools & Technologies

HPLCUPLCSECLCMS/MSICPMS

Industry Keywords

GMP ComplianceICH Regulatory GuidelinesPharmaceutical ManufacturingAnalytical R&DPeptide APIs

About the role

Key responsibilities & impact

Set and achieve objectives consistent with site strategy
Lead analytical method development and validation for peptide and small-molecule APIs
Provide strategic analytical technical leadership and management for the Analytical R&D Department at Corden Pharma Colorado
Lead design, development, and validation of analytical methods supporting peptide programs
Drive high-performing Development teams and cross-functional collaboration
Organize standard work and tactical plans to achieve customer expectations and site objectives
Provide technical support for plant operations, including development or transfer of analytical methods for early-phase clinical GMP programs and validation for late-phase commercial products
Lead the Analytical R&D project portfolio and ensure delivery on budget and on time
Oversee IPC method development, release methods, starting-material and regulatory starting-material testing
Evaluate new projects, identifying risks, innovation opportunities, capabilities, costs, and pricing strategy
Develop long-term analytical strategies aligned with commercialization and regulatory timelines
Communicate with customers and participate in customer meetings and joint steering committees
Lead development, tech transfer, qualification, and validation of stability-indicating methods
Review and approve validation protocols and analytical method validation reports
Oversee external partners supporting validation and external testing
Align Analytical R&D capabilities with strategic goals and competitive advantage
Serve as Analytical Technical Lead for Peptide Development Programs and set CMC direction
Identify development needs and recommend effective training for management-team members
Guide and review strategic technical work to ensure high-quality technical and quality outputs
Ensure compliance with GMP, regulatory, safety, and environmental regulations
Lead functional managers and direct reports, including hiring, training, work assignment, performance appraisal, rewards, discipline, and problem resolution
Develop and manage the Analytical R&D Department budget
Serve on the Development site Leadership Team and contribute to operational oversight
Participate in developing the Corden Pharma brand

Requirements

What you’ll need

Doctoral 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
Deep analytical technical knowledge of peptides and peptide-related products
Expertise in HPLC, UPLC, SEC, LCMS/MS, CHN, AAA, IC, ICPMS, KF, IR, Raman, and related analytical techniques
Ability to read, analyze, and interpret scientific and technical journals, financial reports, and legal documents
Ability to respond to inquiries or complaints from customers, regulatory agencies, or business community members
Ability to write speeches and articles for publication
Ability to effectively present information to top management, scientific and public groups, and boards of directors
Ability to apply advanced mathematical concepts and statistical techniques
Ability to define problems, collect data, establish facts, and draw valid conclusions
Must be able to travel domestically and internationally
Must occasionally lift or move up to 25 pounds
Understanding of basic science and engineering associated with pharmaceutical manufacturing
Demonstrated expertise in Analytical Development and Operations Management
Knowledge of QbD approach and ICH regulatory guidances and framework
Expertise in peptide synthesis in solid and solution phases
Knowledge of techniques to characterize peptide APIs of 10–50 amino acids
Proven experience leading and managing high-performing analytical teams
Project management skills
Analytical problem-solving skills
Working knowledge of regulatory issues in pharmaceutical manufacturing
Leadership, negotiation, relationship-building, influence, motivation, coaching, and mentoring skills
Strong written, oral, communication, and presentation skills
Experience with international environments

Benefits

Comp & perks

401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
Accident Plan
Critical Illness Insurance
Dental Insurance
Disability Insurance
Employee Assistance Program
Flexible Spending Account
Health Insurance PPO/HSA
Hospital Indemnity Plan
ID Theft Protection
Life Insurance
Paid Parental Leave
Tuition Reimbursement
Wellness Program
Vacation – Three Weeks 1st Year
Vision Insurance