Head of Research and Development

Adhesives Research, Inc.; Glen Rock (York County); On-site; USD 180,000 - 260,000; Full time

Job summary

Adhesives Research, Inc. seeks a Head of Research and Development to lead the ARx R&D department, shaping product strategy and regulatory filings in drug delivery. You will guide cross‑functional teams, drive technology transfer, and advance IP protection while aligning with business goals.

The role requires an advanced scientific degree and 20+ years in technical leadership within pharma, including CMC and FDA regulatory experience. Expect travel and leadership across global teams.

Qualifications

• Advanced degree (PhD) in a scientific/engineering discipline.
• 20+ years technical and 10+ years laboratory management experience in pharma/drug delivery.
• Experience with FDA-regulated business and FDA 21 CFR 211 regulations.
• In-depth CMC documentation preparation, regulatory requirements for oral thin film, transmucosal and transdermal products.
• IP management for pharmaceutical technologies including patents and trade secrets.
• Travel 10-15% of the time (including international).

Responsibilities

• Leads ARx Research and Development to create new products and technologies aligned with business goals.
• Develops and implements division‑wide technical policies and programs to support growth.
• Establishes procedures for discovering new technologies, product development, and modifications in compliance with quality systems.
• Ensures CMC activities comply with regulatory requirements and supports regulatory filings.
• Provides technical guidance to clients and internal teams to resolve CMC issues and enable project execution.
• Drives technology transfer from R&D to manufacturing for scale‑up and commercialization.
• Oversees IP strategy, patent filings and freedom-to-operate assessments.
• Collaborates with marketing to showcase innovations and maintain leadership in drug delivery.
• Maintains thorough records and participates in business planning and budgeting.

Skills

Leadership

Regulatory compliance

IP management

FDA regulations

CMC documentation

Pharmaceutical science knowledge

Statistical analysis

Cross-functional leadership

Project management

Communication

Education

PhD in a scientific/engineering discipline

Job description

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Head of Research and Development

Exec/Sr Lvl Off&Mngr Glen Rock, PA, US

Job Summary:

Responsible for leading all aspects of ARx Research and Development Department.

Essential Functions:

• Leads Department in developing new products, formulations and technologies consistent with business priorities, customer needs and application requirements; determines early-stage program feasibility and communicates recommendation to the business team.
• Develops, recommends, and implements division-wide technical research policies and programs to support profitable growth, while also establishing general policies for ARx’s Research and Development Department.
• Establishes and administers procedures for discovering new technologies, developing new products, and modifying existing products, ensuring compliance with applicable quality systems and regulations. Develop and author white papers, technical reports, and case studies for marketing and publishing purposes, communicating the company's technical expertise, capabilities, and successful project outcomes.
• Ensure that all CMC activities comply with global regulatory requirements (e.g., FDA, EMA), industry standards (e.g., GMP, ICH) and internal SOPs.
• Prepare and review CMC sections for regulatory filings (Pre-IND, IND, NDA, IMPD, etc.) and ensure the appropriate documentation for regulatory inspections.
• Provide technical guidance to clients and internal teams to resolve CMC-related issues and ensure seamless project execution.
• Facilitate the technology transfer process from R&D to manufacturing, ensuring that all CMC documentation supports scale-up and commercialization activities.
• Ensures establishment and maintenance of adequate records for formulas, processing methods, testing methods and product construction standards; assures organization of technical information in frameworks which readily afford business organizational efficiency.
• Ensures R&D development activities will maintain ARx’s leadership role in developing innovative technologies in the oral thin film, transmucosal and transdermal drug delivery spaces.
• Works closely with customers and project teams to ensure the successful progression of developmental projects to commercialization.
• Participates in annual and long-range business planning; develops technical strategies consistent with overall business strategy; effectively positions the business for sustainable and profitable commercial revenue streams.
• Leads business in formulation and implementation of intellectual property strategy yielding significant competitive advantage; monitors and leads the business in effectively understanding relevant intellectual property landscape; maintains adequate records to support intellectual property-related actions; assists Patent Counsel in obtaining patent protection and assuring freedom to operate.
• Coordinates invention disclosures from scientists and decides which findings merit patent filing.
• Works with patent attorneys to draft claims and review filings.
• Oversees freedom-to-operate (FTO) assessments to ensure projects don’t infringe competitors’ IP.
• Manages confidentiality agreements (CDAs) and material transfer agreements (MTAs) when collaborating with clients or partners.
• Work closely with the marketing team to produce high-quality content that showcases the company's innovations and positions the organization as a leader in the drug delivery space.
• Maintains current awareness of pharmaceutical and drug delivery technical progress via avenues including:
• Industry peer networking
• Participating in industry groups
• Forecasts operating and capital expense requirements and manages to budgets.
• Effectively manages technical organization including but not limited to assuring up-to-date position descriptions, establishment and auditing of performance expectations, annual reviews, individual development plans, and training.
• Ensures all subordinate associates are fully oriented and trained; assure a safe work environment and that all practices are conducted in a safe and effective manner; manage with safety, associate well-being and environmental practices as a priority.
• Effectively communicates functional status within function as well as across division.
• Conducts all aspects of position in a professional, respectful manner consistent with ARx Guiding Principles; embraces 6S LEAN culture; organizes personal work areas and appearance consistent with corporate and divisional professional image.

Additional Responsibilities:

• Performs other duties and responsibilities as assigned.

Job Specifications:

• Advanced degree (PhD) in a scientific and/or engineering discipline with focus in chemistry, pharmaceutical sciences, pharmacology, biotechnology or related area.
• 20+ years technical and 10+ years laboratory environment management experience in pharmaceutical and/or drug-delivery business; preferably experienced with transdermal, transmucosal oral thin film, and fast dissolve applications/technologies.
• Experienced with FDA-regulated business and regulatory requirements necessary to operate in compliance with FDA 21 CFR 211 regulations; familiarity with all stages of pre-clinical and clinical therapeutic offering development.
• In-depth understanding of CMC documentation preparation, regulatory requirements and guidelines related to oral thin film, transmucosal, and transdermal products.
• Demonstrated expertise in successfully preparing and submitting regulatory filings to the U.S. Food and Drug Administration (FDA), leading to the approval and commercialization of pharmaceutical products.
• Deep understanding of in-vitro and in-vivo models for testing of oral thin films and transdermal drug delivery devices.
• Experienced with DEA regulations for handling controlled substances (e.g. Schedules II-V).
• Proven experience in managing intellectual property (IP) for pharmaceutical technologies, including patents and trade secrets.
• In-depth understanding of drug pharmacokinetics and pharmacology
• Strong leadership, influencing, interpersonal, negotiation and communication skills.
• Expert in design control and statistical analysis.
• Advanced proficiency in using standard desktop software applications.
• Ability to travel 10-15% of the time (including some international).