Scientific Search
Vandalia, Ohio
Location: Dayton, OH Full relocation available Check out for all of our current openings Are you a leader that is a true change agent? Do you love to work in a high energy, collaborative environment? Do you consider yourself someone that can make an impact while mentoring and leading others? This is an amazing opportunity for the right person. The team is ready for growth!! You will be offered an incredibly competitive compensation package along with a full relocation package and much more! Develops and manages global activities for development of commercially viable pharmaceutical dosage forms with the main emphasis on solid controlled release dosage forms this includes innovative formulation concepts, technologies and strategies, CMC Documentation, Product Development and Analytical/Bioanalytical methods development and testing, as well as IVIV correlation. Leader is responsible for internal specialty Pharma projects and client-sponsored projects from development of prototypes, manufacture of clinical supplies to commercial-scale process optimization and validation. In collaboration with peers, contributes to the growth of the Company and leads business strategies with regard to scientific aspects, to focus on common goals and optimize the organizational efficiency. Incumbent ensures to reach corporate goals and objectives aligned with corporate vision and mission. Responsibilities Delivers the best pharmaceutical development and life cycle management strategies to all external and internal customers. Develops and expands the R&D expertise through recruitment, retention, training and personal development. Specifies, develops and maintains the orientations, vision and mission of his department. Conducts and manages development projects and ensures the successful tech transfer of new products and/or processes to production per timelines and budget. Reviews the research projects portfolio and establishes development strategies for upcoming projects. Participates in the evaluation process for new acquisitions and product development, and is involved in due diligences to provide scientific expertise. Develops and manages the overall Pharmaceutical Development projects budget. Consolidates the budget, timelines and resources to deliver the development programs and ensures that it is respected. Applies continuous improvement, risk based and QbD approaches to reduce development times and improve the department efficiency. Creates an environment that stimulates the creation of the (IP) value by the development of new products corresponding to specific needs to our physicians and patients. Provides strategic and scientific input to business development and supports the commercial team. Through specific expertise, manages the development of new formulation for new products and/or existing products, while maximizing the creation and the development of intellectual protection. Develop models for getting in vivo/ in vitro correlation information to mitigate clinical trials failure risks. Develop and/or assist management in locating new technologies that will be of interest to the Company's product development objectives. Keep current with regulations, technical knowledge and with patents in the area of oral drug delivery and obtain patents. Selects, manages and develops business relationship with most appropriate partners to ensure adherence to industry best practices, ensures industry-best development times with commercially attractive and effective formulations at a competitive cost. Approves the writing of pharmaceutical development reports and ensures they are in agreement with the appropriate regulatory requirements. Ensures market intelligence surveillance to be aware of new best practices in the industry in order to stay in front of the competition. Establishes and manages processes to ensure product quality, safety and efficacy. Hires, assigns, develops, supervises and retains employees under his supervision. Requirements Ph.D, preferred ideally in pharmacy or chemistry 10-15 years' experience in product development, in a pharmaceutical company. 5 years in a leadership role is required Knowledge of pharmaceutical operations, including tableting, particle coating, encapsulation, fluid bed operation and microencapsulation. Knowledge of cGMP's, FDA, DEA and OSHA regulations Ability to respond effectively to the most sensitive inquiries or complaints Ability to make effective and persuasive presentations on controversial or complex topics to senior management, public groups, and/or boards of directors Ability to define problems and create efficient solutions Ability to maintain the highest degree of integrity, represent the Company's high ethics, moral behavior, and professionalism Quality of leadership and capability of coordinating and supervising the work of employees Ability to motivate and develop others Business and political awareness Strong working knowledge of government drug registrations and policies Strong working knowledge of American and international regulations and regulatory bodies Facility to adapt to a rapidly changing environment and to manage priorities Strong decision-making, problem solving, and trouble-shooting skills Excellent written and oral communication skills with the Company's various internal and external stakeholders Proficient in Microsoft Office including advanced skills in Excel (Pivot tables, V-lookup, Macros, If Statements, Formulas). Able to prioritize duties and manage multiple projects from start to finish with minimal supervision. Exceptional attention to detail and excellent organizational skills. Ability to accommodate up to 25% travel. For immediate consideration, email and mention Job#
Location: Dayton, OH Full relocation available Check out for all of our current openings Are you a leader that is a true change agent? Do you love to work in a high energy, collaborative environment? Do you consider yourself someone that can make an impact while mentoring and leading others? This is an amazing opportunity for the right person. The team is ready for growth!! You will be offered an incredibly competitive compensation package along with a full relocation package and much more! Develops and manages global activities for development of commercially viable pharmaceutical dosage forms with the main emphasis on solid controlled release dosage forms this includes innovative formulation concepts, technologies and strategies, CMC Documentation, Product Development and Analytical/Bioanalytical methods development and testing, as well as IVIV correlation. Leader is responsible for internal specialty Pharma projects and client-sponsored projects from development of prototypes, manufacture of clinical supplies to commercial-scale process optimization and validation. In collaboration with peers, contributes to the growth of the Company and leads business strategies with regard to scientific aspects, to focus on common goals and optimize the organizational efficiency. Incumbent ensures to reach corporate goals and objectives aligned with corporate vision and mission. Responsibilities Delivers the best pharmaceutical development and life cycle management strategies to all external and internal customers. Develops and expands the R&D expertise through recruitment, retention, training and personal development. Specifies, develops and maintains the orientations, vision and mission of his department. Conducts and manages development projects and ensures the successful tech transfer of new products and/or processes to production per timelines and budget. Reviews the research projects portfolio and establishes development strategies for upcoming projects. Participates in the evaluation process for new acquisitions and product development, and is involved in due diligences to provide scientific expertise. Develops and manages the overall Pharmaceutical Development projects budget. Consolidates the budget, timelines and resources to deliver the development programs and ensures that it is respected. Applies continuous improvement, risk based and QbD approaches to reduce development times and improve the department efficiency. Creates an environment that stimulates the creation of the (IP) value by the development of new products corresponding to specific needs to our physicians and patients. Provides strategic and scientific input to business development and supports the commercial team. Through specific expertise, manages the development of new formulation for new products and/or existing products, while maximizing the creation and the development of intellectual protection. Develop models for getting in vivo/ in vitro correlation information to mitigate clinical trials failure risks. Develop and/or assist management in locating new technologies that will be of interest to the Company's product development objectives. Keep current with regulations, technical knowledge and with patents in the area of oral drug delivery and obtain patents. Selects, manages and develops business relationship with most appropriate partners to ensure adherence to industry best practices, ensures industry-best development times with commercially attractive and effective formulations at a competitive cost. Approves the writing of pharmaceutical development reports and ensures they are in agreement with the appropriate regulatory requirements. Ensures market intelligence surveillance to be aware of new best practices in the industry in order to stay in front of the competition. Establishes and manages processes to ensure product quality, safety and efficacy. Hires, assigns, develops, supervises and retains employees under his supervision. Requirements Ph.D, preferred ideally in pharmacy or chemistry 10-15 years' experience in product development, in a pharmaceutical company. 5 years in a leadership role is required Knowledge of pharmaceutical operations, including tableting, particle coating, encapsulation, fluid bed operation and microencapsulation. Knowledge of cGMP's, FDA, DEA and OSHA regulations Ability to respond effectively to the most sensitive inquiries or complaints Ability to make effective and persuasive presentations on controversial or complex topics to senior management, public groups, and/or boards of directors Ability to define problems and create efficient solutions Ability to maintain the highest degree of integrity, represent the Company's high ethics, moral behavior, and professionalism Quality of leadership and capability of coordinating and supervising the work of employees Ability to motivate and develop others Business and political awareness Strong working knowledge of government drug registrations and policies Strong working knowledge of American and international regulations and regulatory bodies Facility to adapt to a rapidly changing environment and to manage priorities Strong decision-making, problem solving, and trouble-shooting skills Excellent written and oral communication skills with the Company's various internal and external stakeholders Proficient in Microsoft Office including advanced skills in Excel (Pivot tables, V-lookup, Macros, If Statements, Formulas). Able to prioritize duties and manage multiple projects from start to finish with minimal supervision. Exceptional attention to detail and excellent organizational skills. Ability to accommodate up to 25% travel. For immediate consideration, email and mention Job#