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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in pharmaceutical product development, including formulation, scale-up, and commercial launch of sterile injectable products. Proven ability to lead cross-functional teams and manage portfolio governance while ensuring compliance with regulatory standards.
Highest-signal resume keywords
PharmD Or PhD In Pharmacy10+ Years In Pharmaceutical Product DevelopmentDeep Knowledge Of Sterile Injectable DevelopmentLeadership In Technical Or Scientific TeamsStrong Business And Financial Acumen
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Product Development StrategyFormulation DevelopmentAseptic ProcessingCGMP ComplianceTechnology TransferAnalytical Method ReadinessQuality Risk AssessmentPortfolio PrioritizationValidation ProcessesChange Control
Soft Skills
Exceptional LeadershipInfluenceCommunication SkillsChange ManagementCollaboration
Tools & Technologies
MS Office Suite
Industry Keywords
Pharmaceutical ManufacturingRegulated EnvironmentQuality SystemsRisk-Based Decision MakingExecutive ReportingCross-Functional ProgramsClinical Fit AssessmentPatient Need EvaluationLifecycle ImprovementsInspection-Ready Documentation
About the role
Key responsibilities & impact- Develop and execute the enterprise R&D and product development strategy
- Own portfolio governance and prioritization for new products, acquired product transfers, reformulations, line extensions, shortage-response opportunities, and lifecycle improvements
- Lead integration and phased development of products added through strategic portfolio acquisitions
- Direct the stage-gated new product development process from research and clinical fit assessment through formulation, pilot development, validation, stability, change control, and commercial launch
- Evaluate product concepts for patient and clinical need, medication-safety impact, regulatory pathway, intellectual property or commercial-copy considerations, manufacturability, capacity, sourcing, quality risk, and financial viability
- Provide scientific and clinical leadership for formulation development, process characterization, scale-up, analytical method readiness, component qualification, stability strategy, and technology transfer
- Partner with Quality, Pharmacy Services, Technical Operations, Manufacturing, Engineering, Supply Chain, Commercial Operations, Customer Service, and Finance
- Establish portfolio and program metrics, executive reporting, resource plans, and decision forums
- Ensure development documentation is complete, scientifically sound, inspection-ready, and compliant with FDA requirements, cGMP expectations, state pharmacy requirements, internal procedures, and data-integrity standards
- Provide executive oversight for product development reports, formulations, master batch records, specifications, stability protocols and reports, validation assessments, change controls, and supporting technical documentation
- Build, develop, and lead a high-performing multidisciplinary R&D organization
- Represent R&D in executive planning and customer or partner discussions
- Perform other duties as assigned
Requirements
What you’ll need- PharmD, PhD, or advanced degree in pharmacy, pharmaceutical sciences, chemistry, chemical engineering, or a closely related scientific discipline
- 10+ years of progressive experience in pharmaceutical product development, sterile drug products, 503B outsourcing, pharmaceutical manufacturing, or a closely related regulated environment
- 7+ years leading technical or scientific teams
- Demonstrated success leading products from concept through formulation, scale-up, validation, stability, technology transfer, and commercial launch
- Deep working knowledge of sterile injectable or compounded drug-product development, aseptic processing, cGMP requirements, quality systems, and risk-based decision making
- Experience establishing portfolio priorities, allocating resources, managing cross-functional programs, and communicating recommendations to executive leadership
- Strong business and financial acumen
- Exceptional leadership, influence, communication, and change-management skills
- Efficiency with MS Office suite
- At least 18 years of age
- Able to successfully complete a drug and background check
- Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas
Benefits
Comp & perks- Comprehensive health and wellness benefits including medical, dental and vision
- 401k retirement program with company match
- 25 paid days off plus 8 paid holidays per year
- Future career advancement opportunities