Share Email Opening Title Project Manager, Product Development  Category Research & Development   Description Primary Objective of Position The Project Manager has overall responsibility for the leadership and management of Pharmaceutical Product Development projects (pre-formulation through commercial phase solid oral dose products). Projects may be complex, spanning multiple departments within Recro as well as external clients of the Gainesville, Georgia site. Major Duties/Responsibilities Assume the role of client advocate, responsible to ensure projects are delivered on time, on budget, and to the client’s expectations. Serve as the primary point of contact for clients and project teams. Lead cross-functional process development project teams through the product development phases from initial business case development to product launch and commercialization. Projects could include completely new products, product modifications, line extensions, technology transfer, or product/process scale up activities or facility expansion and upgrade activities, as required. The PM must work successfully with a diverse group of team members, both employees and clients of Recro, and serves as the liaison between Recro and clients/customers with respect to projects and related activities. Work with Business Development to support potential new business, and changes in scope of existing business. Write and/or review proposals and work plans for Product Development projects. Develop full project plans, including timeline, critical path assessment, risk assessment, contingency and mitigation planning, communication planning and full scope capture during the project planning phase. Develop a project budget and initiate project financial tracking. Monitor the project budget and track milestones to enable accurate and appropriate invoicing and revenue recognition. Measure and report cost and schedule performance against objectives Establish and maintain files for design history and project business documentation. Manage the program critical path including risk management and contingency planning. Document and track milestones and monitor adherence to the project plan and schedule. Maintain visual tools for program or project tracking and management and communicate plan goals, status, requirements, and deliverables to all team members, stakeholders, and sponsors.   Position Requirements Minimum Job Qualifications Education: BS in Science or related field required Experience: Minimum of six (6) years of relevant work experience in scientific or engineering product development and/or project management; Minimum of 4 years of work experience within the pharmaceutical industry; Experience managing multiple projects at various phases of the phrmaceutical development process is highly preferred. Knowledge/Skills/Abilities Demonstrated experience in project management of Pharmaceutical product development projects Ability to understand cGMPs and other regulatory guidelines applicable to medical/pharmaceutical industry. Ability to manage multiple priorities in a manufacturing/process development environment. Strong professional writing skills and ability to prepare presentations and project plans. Demonstrated interpersonal and leadership skills with the ability to interact with other departments and customers /clients. Demonstrated effectiveness and efficiency leading others in a team environment. Solid working knowledge of MS Office (Word, Excel, PowerPoint, Outlook), Internet. Ability to write reports and business correspondence. Ability to effectively present information and respond to questions from groups of managers, clients, and customers. Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions and decimals. Ability to compute rate, ratio, and percent. Ability to apply concepts of basic algebra and geometry. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Physical and Mental Demands and Work Environment - The physical and mental demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Physical Demands: While performing the duties of this job, the employee is occasionally required to stand. The employee is occasionally required to walk; reach with hands and arms; stoop, kneel, crouch, or crawl and talk or hear. The employee is frequently required to sit and use hands / fingers. Mental Demands: While performing the duties of this job, the employee is regularly required to use English written and oral communication skills; interact appropriately with staff, management, clients and others encountered in the course of work; read and interpret a variety of documents and instructions furnished in written, oral, diagram, or schedule form; analyze and solve practical problems; generate technical reports of project status; interpret technical and engineering data; establish priorities; and work on multiple assignments and projects concurrently. The employee is regularly required to apply computer skills covering word processing, project management, presentation, and spreadsheet software. The employee is regularly required to apply mathematical formulae to prepare and analyze project costs, labor requirements, etc. for project assessments and proposals. Work Environment: In certain assignments, the employee may occasionally work near moving equipment and be exposed to toxic or caustic chemicals, biological hazards, airborne fumes, and loud prolonged noise. The employee works under typical office conditions. The noise level in the work environment is usually quiet to moderate.   About the Organization Societal is a bi-coastal contract development and manufacturing organization (CDMO) with expertise to deliver on our client's needs, regardless of complexity level. These projects span pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms. We provide industry leading support for small molecule therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market. We do all of this in our best-in-class facilities in San Diego, California and Gainesville, Georgia. New hires will pass a background check and drug screen as a condition of employment.   EOE Statement We are an EOE dedicated to a diverse workforce and a Drug-Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other characteristic protected by law. If you require an accommodation to complete the application or interview process, please contact careers@societalcdmo.com.   EmpID None Specified  This position is currently not accepting applications. To search for an open position, please go to http://Societal.appone.com WE ALSO RECOMMEND Other Jobs Within Same Category -- None found -- Other Jobs Within 60 Miles -- None found --

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