Senior Scientist, Nasal and Inhaled Product Development

Kenox Pharmaceuticals, Inc; Princeton (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Kenox Pharmaceuticals, Inc in Monmouth Junction, New Jersey is seeking a Senior Scientist II to lead complex pharmaceutical product-development activities across OINDP platforms. The role focuses on nasal sprays, soft-mist inhalation products, nebulized products, DPIs, and drug-device combinations.

You will develop phase-appropriate strategies, mentor staff, and drive cross-functional workstreams through pre-IND to commercial-readiness milestones, ensuring quality and regulatory alignment.

Qualifications

• Advanced degree in pharmaceutical sciences, chemistry, or engineering is preferred.
• 7+ years of progressive pharmaceutical-development experience is typical.
• Expertise in blending and spray-drying for OINDP formulations.
• Experience with DPIs, nasal sprays, and inhalation products is strongly preferred.
• Knowledge of QbD, cGMP, GLP, ICH guidance, and FDA expectations.
• Ability to lead studies, mentor staff, and communicate with senior leadership.

Responsibilities

• Lead complex product-development programs from concept through tech transfer.
• Design and optimize blending and spray-drying for peptide-containing formulations.
• Develop phase-appropriate study plans and risk assessments.
• Apply QbD to define CPPs, CQAs, and control strategies.
• Interpret data, identify risks, and propose scientifically sound solutions.
• Author and review development plans, protocols, reports, and regulatory content.

Skills

OINDP formulation & development

Blending & spray-drying

QbD & risk assessment

Analytical development

Process development

Product performance testing

Technical problem solving

Cross-functional leadership

Regulatory documentation

Education

Advanced degree in pharmaceutical sciences or related field

Bachelor's degree with substantial industry experience

7+ years pharma development experience

Job description

Reports To: Director of Product Development, Vice President, Research, Development, and Manufacturing, or designee

Position Summary

The Senior Scientist II is a senior technical individual contributor who leads complex pharmaceutical product-development activities and provides advanced scientific guidance across formulation, analytical, process-development, and product-performance programs. The role supports orally inhaled and nasal drug products (OINDPs), including nasal sprays, soft-mist inhalation products, nebulized products, dry-powder inhalation products, and related drug-device combination products.

The Senior Scientist II independently develops and executes phase-appropriate technical strategies; leads cross-functional workstreams; authors, reviews, and approves key development documentation; mentors scientific staff; oversees internal and external studies; and supports development programs through pre-IND, IND, NDA/ANDA, clinical, and commercial-readiness milestones.

Essential Duties and Responsibilities

Technical and Program Leadership

• Design and optimize blending and spray drying processes for novel OINDP drug product formulations containing peptides & other biologics and defining CPPs, CQAs and control strategies.
• Lead complex product-development programs and technical workstreams from feasibility and proof of concept through pre-formulation, formulation, analytical development, process development, product-performance testing, stability, scale-up, and technology transfer.
• Develop phase-appropriate study strategies, experimental plans, timelines, risk assessments, decision criteria, and technical recommendations.
• Apply QbD and risk-based principles to define and evaluate critical quality attributes, critical material attributes, critical process parameters, and product-performance characteristics.
• Independently interpret data, identify technical risks, lead troubleshooting and root-cause analysis, and recommend scientifically sound solutions.
• Provide technical input to development plans, project schedules, resource plans, budgets, client deliverables, and regulatory-support activities.

OINDP Development and Testing

• Lead development and characterization of OINDP products, including nasal sprays, soft-mist inhalation products, nebulized products, DPIs, and related drug-device combination products.
• Plan and oversee formulation, pre-formulation, analytical, process-development, device-performance, and in vitro product-performance studies.
• Support selection and optimization of APIs, excipients, components, devices, manufacturing processes, and analytical control strategies.
• Lead evaluation of stability, compatibility, aerosol performance, spray performance, particle-size distribution, delivered dose, and other relevant product-quality attributes as applicable.

Documentation, Data Quality, and Regulatory Support

• Independently author, review, and approve protocols, methods, development plans, technical reports, specifications, risk assessments, batch records, data summaries, and CMC documentation.
• Ensure that data and records are accurate, complete, traceable, scientifically defensible, and maintained in accordance with established procedures, good documentation practices, and data-integrity expectations.
• Prepare and present technical findings, development conclusions, risk assessments, and recommendations to internal management, clients, partners, and cross-functional program teams.
• Contribute technical content to pre-IND briefing packages, INDs, NDAs, ANDAs, responses to information requests, and other regulatory submissions or correspondence.

Team Mentoring and Cross-Functional Collaboration

• Mentor, coach, and provide technical oversight to Scientists, Associate Scientists, technicians, and other junior staff.
• Review experimental plans, raw data, calculations, laboratory records, reports, and presentations prepared by junior staff; provide actionable feedback and ensure quality of work product.
• Coordinate closely with Analytical Development, Formulation, Process Development, Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs, Project Management, Supply Chain, and Business Development.
• Communicate technical status, risks, priorities, resource requirements, and recommended decisions clearly and promptly.

External Partner, Scale-Up, and Technology Transfer Support

• Define, manage, and review technical scopes of work for CROs, CMOs, testing laboratories, suppliers, and other external partners.
• Review external data packages, assess technical performance, resolve issues, and ensure deliverables meet program and quality expectations.
• Provide technical leadership for process scale-up, process characterization, engineering activities, manufacturing readiness, and technology-transfer efforts.
• Support equipment selection, qualification, and use; contribute to IQ/OQ/PQ activities, SOP development, laboratory readiness, and continuous-improvement initiatives.

Quality, Compliance, and Laboratory Support

• Conduct work in accordance with applicable Company procedures, laboratory safety requirements, GMP/GLP expectations, data-integrity principles, and applicable ICH/FDA requirements.
• Support investigations of deviations, OOS/OOT results, non-conformances, and atypical trends; contribute to root-cause analysis, CAPA, and risk-mitigation plans.
• Promote a safe, organized, compliant, and efficient laboratory environment and support inspection readiness.

Qualifications

• Advanced degree in pharmaceutical sciences, chemistry, chemical engineering, biomedical engineering, mechanical engineering, or a related discipline preferred; bachelor’s degree with substantial relevant industry experience may be considered.
• Typically seven or more years of progressive pharmaceutical-development experience, including demonstrated independent technical leadership; advanced-degree experience may be considered.
• Expertise in the design and development of blending and spray drying processes for OINDP formulations containing peptides & other biologics.
• Strong experience in formulation, analytical development, process development, product-performance testing, stability, scale-up, and technical documentation
• Demonstrated experience with OINDPs, inhalation products, nasal products, nebulized products, DPIs, or drug-device combination products strongly preferred.
• Working knowledge of QbD, cGMP, GLP, ICH guidance, FDA expectations, CMC development, data integrity, quality systems, and technology transfer.
• Proven ability to lead complex studies, manage multiple priorities, mentor staff, communicate with clients and senior leadership, and solve technical problems independently.

Core Competencies

• Advanced product-development and scientific leadership
• OINDP, formulation, analytical, and process-development expertise
• QbD, risk assessment, and complex problem-solving
• Technical writing, data interpretation, and regulatory support
• Cross-functional collaboration and client communication
• Mentoring, review, and technical quality oversight
• External partner oversight and technology transfer
• Quality, safety, data integrity, and operational discipline

Work Environment and Travel

This position is primarily based at the Company’s Monmouth Junction, New Jersey location and includes laboratory and office-based responsibilities. Reasonable travel may be required for client meetings, vendor and CMO/CRO visits, technology-transfer activities, audits, or scientific conferences.

Kenox Pharmaceuticals is an equal opportunity employer and considers applicants without regard to legally protected characteristics. The Company is committed to maintaining a professional workplace that promotes safety, inclusion, respect, quality, and scientific integrity.