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Posted : Sunday, March 17, 2024 07:19 PM
Job Summary
Responsible for leading all aspects of ARx Research and Development Department.
Essential Functions: Leads Department in developing new products 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 needed to support profitable growth and implements general policies for ARx’s Research and Development Department.
Establishes and administers procedures pertaining to discovery of new technologies, development of new products, alteration and existing product modifications maintaining compliance to applicable quality systems and regulations.
Ensures R&D development activities will maintain ARx’s leadership role in developing innovative technologies in the oral thin film, transmucossal 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.
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.
Maintains current awareness of pharmaceutical and drug delivery technical progress via avenues including: Industry peer networking Monitoring relevant literature Participating in industry groups Attending relevant conferences 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 AR 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 focused in chemistry, pharmaceutical sciences, biology, biotechnology or related area.
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.
Experienced with DEA regulations for handling controlled substances (e.
g.
Schedules II-V).
10+ years technical and 5+ 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.
Strong leadership, influencing, interpersonal, negotiation and communication skills.
Expert in design control and statistical analysis.
Proficiency with standard desktop computer software applications.
Ability to travel 10-15% of the time (including some international).
Essential Functions: Leads Department in developing new products 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 needed to support profitable growth and implements general policies for ARx’s Research and Development Department.
Establishes and administers procedures pertaining to discovery of new technologies, development of new products, alteration and existing product modifications maintaining compliance to applicable quality systems and regulations.
Ensures R&D development activities will maintain ARx’s leadership role in developing innovative technologies in the oral thin film, transmucossal 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.
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.
Maintains current awareness of pharmaceutical and drug delivery technical progress via avenues including: Industry peer networking Monitoring relevant literature Participating in industry groups Attending relevant conferences 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 AR 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 focused in chemistry, pharmaceutical sciences, biology, biotechnology or related area.
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.
Experienced with DEA regulations for handling controlled substances (e.
g.
Schedules II-V).
10+ years technical and 5+ 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.
Strong leadership, influencing, interpersonal, negotiation and communication skills.
Expert in design control and statistical analysis.
Proficiency with standard desktop computer software applications.
Ability to travel 10-15% of the time (including some international).
• Phone : NA
• Location : Glen Rock, PA
• Post ID: 9058120625
