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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 Research and Development, with a strong focus on CMC development for small molecule drug substances, regulatory submissions, and GMP compliance. Proven ability to lead cross-functional teams and manage external partnerships to drive successful drug development outcomes.
Highest-signal resume keywords
Process Chemistry Research And DevelopmentCMC Development For Small Molecule Drug SubstanceRegulatory SubmissionsGMP ComplianceCollaboration With CRO And CDMO
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Organic ChemistryPharmaceutical SciencesContinuous ProcessingCatalysisBiocatalysisHigh Throughput ExperimentationSalt/Crystalline Form SelectionOligonucleotide ChemistryManufacturing StrategyBudget Management
Soft Skills
Interpersonal SkillsCommunication SkillsOrganizational SkillsDetail-OrientedAgility
Industry Keywords
CGMP RequirementsDrug Development PhasesAPI FormsPharmaceutical DevelopmentIntellectual Property
Tech Stack
Tools & technologiesSaltStack
About the role
Key responsibilities & impact- Lead Process Chemistry Research and Development for one or more projects from early to late phase
- Design early-phase and late-phase/commercial drug substance processes and lead demonstration from lab to pilot plant
- Provide chemistry and technical leadership throughout the product lifecycle
- Participate in or lead activities to identify final API forms for pharmaceutical development
- Collaborate with formulations, analytical, operations, engineering, and quality teams as part of the CMC team
- Identify, collaborate with, and lead external CRO and CDMO organizations to achieve deliverables
- Analyze external experimental data to drive synthetic experimental plans at CROs and CDMOs
- Author or co-author regulatory submissions
- Define manufacturing strategy and execution, including GMP requirements and issue resolution
- Assess and apply new trends and concerns in process development, quality, and manufacturing
- Manage quarterly budgeting of drug-substance-related activities
- Contribute to inventions that add value to Praxis and strengthen its intellectual property position
Requirements
What you’ll need- Advanced degree or commensurate experience equivalent in Organic Chemistry, Pharmaceutical Sciences, Engineering or related discipline
- Minimum of 5+ years of industry experience in CMC specifically for small molecule drug substance
- Scientific track record or working knowledge in continuous processing, catalysis, biocatalysis and/or high throughput experimentation desirable
- Strong knowledge of US and EU cGMP requirements and best practices relating to drug substances and drug products
- Strong knowledge of CMC development across all phases of drug development from initial regulatory filings through registration, validation and launch
- Experience working with third-party CRO/CMO partners and associated service providers to develop and manufacture pharmaceutical products
- Experience with salt/crystalline form selection preferred
- Experience with oligonucleotide chemistry is a plus
- Ability to work in an agile environment
- Excellent interpersonal and communication skills
- Highly organized and detail-oriented
- Regular computer/device/office equipment use, clear communication, occasional movement, screen work, basic hand coordination, and focus
- Willingness and flexibility to travel as needed
Benefits
Comp & perks- 99% of the premium paid for medical, dental and vision plans
- Company-paid life insurance, AD&D, and disability benefits
- Voluntary plans to personalize coverage
- Dollar-for-dollar 401(k) match up to 6% on eligible contributions
- Long-term stock incentives
- ESPP
- Discretionary quarterly bonus
- Extremely flexible wellness benefit
- Generous PTO
- Paid holidays
- Company-wide shutdowns
- Remote work flexibility
- Travel flexibility as needed