Director, Formulations Development

2 weeks ago

Philadelphia, United States Adare Pharma Solutions Full time

Are you ready to join a growing, global drug development and manufacturing organization that puts people first? Come to Adare We work closely with our pharmaceutical industry partners during all phases of drug development and commercial manufacturing with a mission of improving the lives of patients and medicines essential to people all over the world. Every role within Adare offers you a unique, customized experience with a chance to make a real impact that is critical to our success. With the help of people like you dedicated to our mission, Adare is transforming lives by transforming drug delivery Join our mission at Adare What can Adare offer you? + Medical/dental/vision/life – low employee premiums + 401k with a highly competitive match + Generous PTO, including floating holidays + Career growth and internal opportunities + Tuition reimbursement + Relocation assistance + Performance-based bonus + Employee Recognition Programs We are seeking to hire a Director, Formulations Development to join our Research and Development team… If any of the below describes you, we would love to meet you Summary Adare is seeking a Director, Formulation Development who is interested in joining a highly dynamic and intellectually challenging team. The successful candidate will be responsible for establishing and leading Adare’s drug product development function for the Philadelphia Research and Development location. Adare is seeking a proven leader to drive the strategy, development, scale-up, and execution of oral solid-dosage form processes supporting early and late-stage process development and manufacturing. This individual will lead the Drug Product development team in Philadelphia, including pre-formulation, formulation, scale-up and manufacture for orally-delivered medicines. The ideal candidate will be leading and growing the drug product function in the development and optimization of product spanning pilot-scale, pivotal, and commercial batch manufacturing. They will also be responsible for the overall drug product programs, development of the team and function, authoring/reviewing technical and manufacturing reports and regulatory submissions such as IND, NDA, IMPD, and ANDA. RESPONSIBILITIES AND LEARNING OPPORTUNITIES + Lead in the development of new drug delivery technologies and products. + Produces value-added results through effective recruitment, delegation, performance management, training and development of Formulations Scientists and Technicians + Keep current with regulations and technical knowledge. + Secure and provide adequate scientific formulation support to all assigned projects. + Interface with internal and external clients in project meetings. + Direct priorities for within the function under the direction of and in conjunction with the VP of R&D. + Provide input on project planning. + Ensure all activities comply with OSHA, EPA, DEA and cGMP's regulations. + Maintain detailed records of all work to ensure compliance of all product submissions to the requirements by government agencies. + Prepare and review CMC text for NDA/ANDA/DMF and other regulatory filings. + Prepare and review master batch records, development pharmaceutics reports and other formulation documents. + Provide leadership, training and mentoring to FD scientists and other FD staff. + Participate in the recruiting and hiring of quality individuals to meet the needs of the FD function and the wider organization. + Participate in setting the strategic direction of new technology and product development + Maintain technical expertise and the positions in areas critical to the business. + Participate in proposing and screening of new product ideas and leveraging the company’s drug delivery technologies. + Assist Business Development in preparation of R&D project proposals. Provide input on the technical feasibility and resources required of the project. + Provide cost and man-hour estimates associated with R&D project proposals + Acts as the company’s representative by showing respect and being ambassador for the established beliefs and behaviors of the Company. + Participates in the development and implementation of methods, procedures and regulations necessary for the smooth operation of the business. + Special projects and duties as assigned Requirements + Minimum of MS in Pharmaceutical Sciences or a related field and 12+ years’ experience in the pharmaceutical industry, or PhD in Pharmaceutical Sciences or a related field with 8+ years’ experience in the pharmaceutical industry. + Solid background in pharmaceutics, biopharmaceutics and/or processing technologies in order to be able to invent, innovate and implement new ideas. + Broad knowledge and extensive experience in drug product development projects in various phases to facilitate efficient and successful implementation of projects. + Experience and training, development, and direct supervision of a medium or large size team + Excellent interpersonal written and oral communication skills + Proficient in Microsoft Office including advanced skills in Excel (Pivot tables, V-lookup, Macros, If Statements, Formulas). + Proven experience with effective resource management + Ability to coordinate, contribute to and work within a cross-functional team. + Exceptional attention to detail and excellent organizational skills. Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. PRINCIPALS ONLY NO AGENCIES OR THIRD PARTIES Benefits + Medical/dental/vision/life – low employee premiums + 401k with a highly competitive match + Generous PTO, including floating holidays + Career growth and internal opportunities + Tuition reimbursement + Relocation assistance + Performance-based bonus + Employee Recognition Programs

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