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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in late-stage drug substance development, scale-up, and commercial manufacturing, with a strong focus on regulatory compliance and process optimization. Proven ability to lead cross-functional teams and manage CDMO relationships while ensuring adherence to global cGMP standards.
Highest-signal resume keywords
Ph.D. Or M.S. In Organic Chemistry8+ Years In Drug Substance DevelopmentProcess Development And Scale-UpQuality By Design (QbD)Regulatory Compliance And cGMP
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Drug Substance DevelopmentScale-Up ProcessesTechnical TransferProcess ValidationCritical Process ParametersImpurity ProfilingSolid-State CharacterizationNDA Submission SupportPre-Approval Inspection ManagementICH Guidelines
Soft Skills
Project ManagementOrganizational SkillsLeadership SkillsCommunication SkillsInfluencing Stakeholders
Tools & Technologies
SsNMRXRPDAdvanced Spectroscopic Techniques
Industry Keywords
Pharmaceutical IndustryCDMO RelationshipsCGMP ComplianceRegulatory BodiesInhaled Products
About the role
Key responsibilities & impact- Drive late-stage drug substance development, scale-up, and commercial manufacturing
- Partner with internal CMC, Regulatory, and Quality teams to design, optimize, and define robust, scalable drug substance processes
- Direct optimization and scale-up of manufacturing processes at external partners
- Apply Quality by Design (QbD) and Design of Experiments (DoE) methodologies to establish Critical Process Parameters and Critical Quality Attributes
- Lead technical transfer of drug substance processes across global CDMOs
- Lead scale-up activities and process validation campaigns in alignment with FDA, EMA, and other regulatory bodies
- Oversee commercial-scale manufacturing lines, process consistency, yield optimization, and supply robustness
- Ensure compliance with global cGMP and regulatory standards
- Establish drug substance control strategies, including impurity profiling and Proven Acceptable Ranges per ICH guidelines
- Support authoring and review of CMC sections for global regulatory submissions and responses to agency inquiries
- Collaborate with internal and external stakeholders and report to the Sr. Director of Drug Substance Development
Requirements
What you’ll need- Ph.D. or M.S. in Organic Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a closely related discipline
- 8+ years of progressive experience in drug substance development and manufacturing within the pharmaceutical industry, focusing on late-stage development and commercialization
- Strong background in managing CDMO relationships and outsourcing strategies
- Demonstrated experience in process development, scale-up, and technical transfer
- Knowledge of global regulatory requirements and cGMP compliance
- Excellent project management, organizational, and leadership skills
- Ability to work in a fast-paced, cross-functional environment and influence internal and external stakeholders
- In-depth knowledge of material sciences and solid-state characterization, including ssNMR, XRPD, and advanced spectroscopic techniques
- Strong written and verbal communication skills
- Proven, hands-on experience driving drug substance chemistry, manufacturing, and control (CMC) activities directly supporting a successful NDA submission
- Prior experience preparing for, hosting, or managing a successful regulatory Pre-Approval Inspection (PAI)
- Recognized Subject Matter Expert in late-stage process characterization, including QbD, PAR/NOR establishment, Fate and Purge of impurities studies, and ICH M7/nitrosamine safety assessments
- Highly fluent and well-versed in global ICH guidelines for drug substance development and manufacturing
- Experience with inhaled/inhalation products is a plus