Director/Senior Director, Research, Development, and Manufacturing

Director/Senior Director, Research, Development, and Manufacturing

Company: Kenox Pharmaceuticals Inc.
Location: Monmouth Junction, New Jersey
Employment Type: Full-time
Reports To: Vice-President/President

Position Summary

The Director/Senior Director, Research, Development, and Manufacturing provides executive and operational leadership for Kenox Pharmaceuticals’ research and development, analytical and product testing, manufacturing, supply chain, and technical operations. This role is accountable for advancing pharmaceutical and drug-device combination-product programs from proof of concept and pre-IND development through IND-enabling activities, clinical material supply, GMP manufacturing, and commercial readiness.

The Director/Sr. Director leads technical personnel and cross-functional teams, establishes scalable capabilities and operating systems, ensures compliant and high-quality execution, and partners with the executive leadership team to deliver the Company’s short-, mid-, and long-term strategic objectives. The role serves as a senior technical representative for clients, partners, and the broader scientific and business community.

Essential Duties and Responsibilities

Strategic Planning and Execution

· Partner with the Vice President and executive leadership team to develop, communicate, and execute short-, mid-, and long-term Company strategies.

· Translate corporate objectives into actionable technical, manufacturing, supply chain, capital, staffing, and operational plans.

· Lead initiatives for continuous improvement, technological advancement, operational scalability, and expansion of the Company’s scientific, manufacturing, and people capabilities.

· Evaluate strategic opportunities, identify resource requirements and risks, and make recommendations to executive leadership.

Product Development and Testing

· Maintain end-to-end oversight and accountability for product development activities, including proof-of-concept work, pre-IND development, IND-enabling studies, Generic products, formulation development, analytical development, process development, and orally inhaled and nasal drug product (OINDP) testing.

· Provide technical leadership for development of drug products and drug-device combination products across preclinical, clinical, and commercial stages.

· Draft, review, approve, and ensure appropriate execution of project-related analytical, formulation, process-development, manufacturing, testing, and stability protocols, reports, specifications, and technical documentation.

· Ensure development programs are phase-appropriate, scientifically sound, commercially relevant, and aligned with applicable regulatory expectations.

· Guide technical decision-making, root-cause investigations, risk assessments, development strategies, and data interpretation for client and internal programs.

Project Management and Delivery

· Provide executive oversight for planning, execution, monitoring, and closeout of client projects across R&D, GMP testing, and GMP manufacturing.

· Partner with Project Management to ensure project scope, schedules, budgets, deliverables, risks, dependencies, and resource needs are clearly defined and actively managed.

· Ensure technical and operational projects are delivered on time, within budget, in compliance with quality expectations, and consistent with client requirements.

· Escalate and resolve critical project risks, resource constraints, technical issues, and client concerns.

Operational Leadership

· Provide day-to-day executive oversight of Research and Development, analytical and product testing, manufacturing, supply chain, and related technical operations.

· Lead, direct, and develop technical staff; establish clear reporting relationships, objectives, accountability, and performance expectations.

· Ensure operational processes, staffing, technical capabilities, and resource allocation align with Company strategy, client commitments, product-development priorities, and growth objectives.

· Establish and implement best practices that optimize technical execution, production efficiency, quality, cost, project delivery, and on-time delivery of products and services.

· Build scalable operational infrastructure, including technical capabilities, systems, capacity plans, staffing models, and external partner relationships.

Manufacturing and Production Management

· Lead planning and execution of GLP and GMP clinical manufacturing batches, including engineering, demonstration, exhibit, and clinical supply activities as applicable.

· Oversee IND-enabling development, Phase I/II clinical material supply, and testing of drug-device combination products supporting Phase I through Phase III programs and commercial readiness.

· Ensure adherence to current Good Manufacturing Practices (cGMP), GLP requirements where applicable, and Company quality systems.

· Monitor and improve production efficiency, capacity utilization, cost management, manufacturing readiness, and operational excellence.

· Coordinate the introduction, transfer, scale-up, and manufacture of new products in partnership with R&D, Quality, Manufacturing, Supply Chain, and external service providers.

Quality and Regulatory Compliance

· Ensure technical and operational activities comply with applicable FDA, EMA, WHO, and other international, federal, state, and local regulatory requirements.

· Partner closely with Quality Assurance and Quality Control to maintain compliant quality systems, robust documentation, inspection readiness, data integrity, and product-quality standards.

· Promote a quality-focused culture and ensure timely investigation, corrective and preventive action, change control, deviation management, and risk management.

· Support regulatory submissions, agency interactions, audits, client due diligence, and responses to regulatory or quality-related requests.

Supply Chain and Logistics

· Oversee supply chain operations, including procurement, vendor management, inventory management, materials planning, storage, distribution, and logistics.

· Develop resilient supply chain strategies that mitigate supplier, material, capacity, quality, and continuity risks.

· Ensure appropriate material traceability, inventory controls, lead-time management, and supply continuity for development and manufacturing programs.

· Establish and manage relationships with critical suppliers, contract manufacturing organizations, contract research organizations, and other external partners as needed.

Client, Partner, and Stakeholder Management

· Serve as a primary technical and operational point of contact for clients, partners, and key stakeholders; ensure client satisfaction, technical excellence, and fulfillment of contractual commitments.

· Work with Business Development to support client acquisition, proposal development, technical scoping, due diligence, relationship management, and client retention.

· Represent the Company in client meetings, roadshows, webinars, workshops, technical presentations, and scientific and business conferences.

· Deliver podium presentations at scientific and business conferences as appropriate to strengthen the Company’s market position and technical reputation.

Financial and Operational Performance

· Develop and manage departmental and program budgets; monitor expenditures, capacity, revenue-supporting activities, and cost optimization opportunities.

· Establish, monitor, and report key performance indicators related to quality, safety, project delivery, capacity, productivity, cost, timelines, client performance, and operational effectiveness.

· Provide regular operational reports, analyses, forecasts, and recommendations to the Executive leadership team.

· Support capital planning, equipment investments, facility planning, and business cases for new capabilities.

Leadership and Talent Management

· Recruit, lead, mentor, and retain high-performing technical and operational teams.

· Build a culture of scientific rigor, accountability, collaboration, continuous improvement, quality, safety, and operational excellence.

· Develop organizational capability through workforce planning, training, performance management, succession planning, and leadership-pipeline development.

· Foster effective cross-functional collaboration among R&D, Manufacturing, Quality, Supply Chain, Business Development, Project Management, and executive leadership.

Risk Management, Technology, and Innovation

· Identify, evaluate, and mitigate technical, operational, quality, regulatory, supply chain, project, financial, and business-continuity risks.

· Develop and maintain crisis-management and business-continuity plans for critical operational functions.

· Oversee adoption of phase-appropriate digital technologies, data systems, automation, process analytical technologies, and advanced manufacturing solutions.

· Promote innovation and strategic technology adoption to preserve and strengthen the Company’s competitive position in the CDMO sector.

Qualifications

· Advanced degree in pharmaceutical sciences, chemical engineering, biomedical engineering, chemistry, biology, manufacturing, or a related scientific or engineering discipline; MS, PharmD, , PhD, MBA, or equivalent advanced training preferred.

· Significant progressive leadership experience in pharmaceutical development, analytical development, manufacturing, CDMO operations, or a comparable regulated life-sciences environment.

· Demonstrated experience advancing products from early development through IND-enabling activities, clinical supply, GMP manufacturing, and/or commercial readiness.

· Strong working knowledge of cGMP, GLP, quality systems, FDA expectations, ICH guidance, and applicable regulatory requirements; familiarity with EMA and global regulatory requirements preferred.

· Experience with drug products, inhalation or nasal drug products, combination products, analytical testing, formulation and process development, and technology transfer is strongly preferred.

· Proven ability to lead cross-functional teams, manage budgets and operational KPIs, develop technical talent, and deliver complex client programs.

· Exceptional written, verbal, presentation, negotiation, and stakeholder-management skills.

Core Competencies

· Executive and operational leadership

· Pharmaceutical product-development strategy

· GMP manufacturing and quality systems

· Technical, regulatory, and commercial judgment

· Client relationship and contract-delivery management

· Project, budget, and resource management

· Continuous improvement and scalable operations

· Talent development and cross-functional collaboration

· Risk management and disciplined decision-making

Work Environment and Travel

This position is primarily based at the Company’s Monmouth Junction, New Jersey location. Reasonable travel may be required for client meetings, partner and supplier visits, audits, industry conferences, roadshows, webinars, and other business needs.

Equal Employment Opportunity

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

Job Type: Full-time

Pay: $130,000.00 - $160,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Education:

• Master's (Preferred)

Experience:

• Associate Director Level from Pharma or Biotech: 5 years (Preferred)

Work Location: In person

Salary : $130,000 - $160,000