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Director, Process Research – Development
Corden Pharma - A Full-Service CDMO. Provide strategic technical leadership and management for the Process R&D Department at the Corden Pharma Colorado site .
Posted 10/7/2026full-timeBoulder • Colorado • United StatesLead💰 $195,000 - $215,000 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in Peptide API Development, including process optimization, scale-up for large-scale manufacturing, and compliance with GMP and regulatory standards. Proven ability to lead cross-functional teams, manage project portfolios, and develop CMC strategies aligned with commercialization timelines.
Highest-signal resume keywords
PhD In Chemistry Or EngineeringPeptide API DevelopmentProcess Development StrategiesProject Management SkillsGMP Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Peptide SynthesisAnalytical DevelopmentProcess CharacterizationPurification TechniquesStatistical AnalysisChemical DevelopmentProcess TransferQuality By Design (QbD)Regulatory ComplianceTechnical Leadership
Soft Skills
Strong Communication SkillsLeadership SkillsCoaching And MentoringNegotiation SkillsRelationship Building
Industry Keywords
Pharmaceutical ManufacturingAPI DevelopmentContinuous ImprovementCross-Functional CollaborationCustomer EngagementEnvironmental RegulationsSafety ComplianceTechnical Support
About the role
Key responsibilities & impact- Provide strategic technical leadership and management for the Process R&D Department at the Corden Pharma Colorado site
- Set and achieve objectives consistent with site strategy
- Provide technical leadership for development of peptide and small-molecule APIs
- Develop and monitor plans, build employee capabilities, and embed continuous improvement
- Lead Process R&D teams and cross-functional collaboration with other departments
- Organize standard work and tactical plans for development activities
- Provide technical support for plant operations, including troubleshooting and substantial process improvements
- Manage the Process R&D project portfolio
- Ensure R&D meets customer expectations on budget and on time for route evaluation, process development, analytical development, and process characterization
- Lead technical evaluation of new projects, including risks, innovation opportunities, required capabilities, cost analysis, and pricing strategy
- Devise and execute long-term process development strategies aligned with commercialization and regulatory timelines
- Communicate with customers and participate in customer meetings, providing strategic direction to cross-functional teams
- Lead process development of early- to late-stage peptide products and small-molecule APIs, including development, optimization, and scale-up for large-scale manufacturing
- Align Process R&D capabilities with strategic goals and provide competitive advantage
- Ensure technical resources and skills are in place and appropriately applied
- Serve as Technical Lead for Peptide Development Programs, setting CMC direction and supporting tech transfers and validation execution
- Identify management team development needs, recommend training, and ensure training effectiveness
- Guide and review strategic technical work to ensure high-quality technical and quality outputs
- Participate in developing the Corden Pharma brand
- Ensure compliance with GMP, regulatory, safety, and environmental regulations
- Lead functional managers and their direct reports, including hiring, training, work assignment, performance appraisal, rewards, discipline, and problem resolution
- Develop and manage the Analytical R&D Department budget and ensure expenses remain within budget
- Serve on the Development site Leadership Team
- Act as a key contact for high-level customer interactions and joint steering committees
- Follow safety and environmental responsibilities and support the Quality Management System and cGMP requirements
Requirements
What you’ll need- Doctoral Degree (PhD) or equivalent in Chemistry, Engineering, 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 process transfer
- Ability 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
- Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations
- Ability to apply mathematical operations to frequency distribution, test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis
- Ability to define problems, collect data, establish facts, and draw valid conclusions
- Ability to interpret extensive technical instructions in mathematical or diagram form and deal with multiple abstract and concrete variables
- Must be able to travel both domestically and internationally
- Understanding of the basic science and engineering associated with the manufacture of pharmaceuticals
- Demonstrated expertise in Chemical Development and Operations Management
- Well versed with QbD approach and all ICH regulatory guidances and framework
- Demonstrated expertise and know-how in Peptide Synthesis, both on solid phase and in solution phase
- Well versed with purification techniques for purifying peptide APIs of 10–50 amino acids using various media
- Demonstrated expertise in isolation of peptide API by precipitation and understanding of engineering principles of isolation by filtration
- Project Management skills, including planning, staffing, organizing, directing, and controlling
- Analytical problem-solving skills
- Strong communication skills
- Working knowledge of regulatory issues in Pharmaceutical Manufacturing
- Leadership and negotiation skills
- Ability to build relationships, influence, and motivate others
- Coaching and mentoring skills
- Excellent 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