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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Process Chemistry with a focus on drug substance development, including scale-up and validation. Proficient in authoring regulatory documents and collaborating with cross-functional teams to ensure compliance and successful project execution.
Highest-signal resume keywords
PhD. In Organic ChemistryProcess DevelopmentRegulatory Document AuthoringProcess ValidationCross-Functional Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Process ChemistryRoute ScoutingScale-UpDesign Of Experiments (DOE)CMC StrategiesTroubleshootingTechnical SupportRegulatory SubmissionsValidation ActivitiesManufacturing Processes
Soft Skills
CommunicationCollaborationProblem-Solving
Industry Keywords
CROsCDMOsINDsNDAsMAAsCBE30Type II SubmissionsQuality AssuranceDrug SubstanceLate-Stage Development
About the role
Key responsibilities & impact- Support drug substance-related activities internally and externally
- Interface directly with CROs, CDMOs, and other partners to execute on-time delivery and ensure phase-appropriate process procedures
- Collaborate with CMC and other departments to execute drug substance project needs
- Oversee CDMO Process Chemistry activities for drug substance, focusing on late-stage development and validation across international and US-based CDMOs
- Provide on-site technical support at CDMOs for manufacturing, scale-up, and validation activities
- Troubleshoot manufacturing and packaging process issues
- Author and manage request-for-proposal documents to initiate CDMO work
- Support and author drug substance content for CMC regulatory submissions in the US and rest of world
- Support Quality Assurance audits on-site at CDMOs or remotely as a technical subject matter expert
- Interface with Analytical Chemistry, Formulation Development, Quality Assurance, Supply Chain, and other CMC team members
- Communicate Process Chemistry clearly through verbal and visual presentations
Requirements
What you’ll need- PhD. in Organic Chemistry from Purdue University
- 7+ years as a process chemist in industry
- Experience leading route scouting, process development, scale-up, DOE, process validation, and CMC strategies for small molecule drug substances
- Experience authoring and reviewing regulatory documents, including INDs, NDAs, MAAs, CBE30, and Type II submissions
Benefits
Comp & perks- Market-leading compensation
- 401(k) with employer match
- Employee Stock Purchase Program (ESPP)
- Pre-tax commuter benefits (transit and parking)
- Referral bonus for hired candidates
- Subsidized lunch and parking on in-office days
- 100% employer-paid medical, dental, and vision premiums for you and your dependents
- Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
- Fertility & family-forming benefits
- Expanded mental health support (therapy and coaching resources)
- Hybrid work model with flexibility
- Flexible, “take-what-you-need” paid time off and company-paid holidays
- Comprehensive paid medical and parental leave
- Skill development and internal mobility opportunities
- Career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching
- Financial rewards, peer-to-peer recognition, and growth opportunities