Share Email Opening Title Director, Product Development  Category Research & Development   Description Primary Objective of Position The Director, Product Development, leads the formulation, process development, and analytical development teams, and directs all aspects of Product Development at the Recro Gainesville LLC site (Gould Drive). The function includes scientific, project management and engineering support for technology transfer projects, development of formulations, methods, and processes for new product candidates, and scale-up activities. The function will also support existing commercial processes where appropriate. The position will also assist in assessing new business development opportunities for the site. The position requires close cooperation with other relevant site disciplines to ensure corporate and site objectives are met. Major Duties/Responsibilities Direct and lead the effective development and/or transfer of products, methods, processes, and technology to the Gainesville site. Support senior management and Business Development in due diligence, selection and commercialization of new products and technologies from external partners Interact directly with internal and external clients in relation to tech transfers, new product introductions, technology enhancements and process improvements where appropriate. Provide scientific leadership for the site in the areas of manufacturing technology, processes, and regulatory requirements. Operational management of the Product Development group in the areas of cGMP and Training EHS&S Budget preparation and monitoring Project Management Objective setting and Performance Reviews Responsible for hiring all members of the Product Development team and ensuring they are adequately trained to perform all necessary tasks of their roles Responsible for documentation generation, review, and approval as required, particularly, but not exclusively in the areas of Product Development, CMC, Tech Transfer and Validation. Lead or Supervisory Responsibilities: Supervises work of others, including planning, assigning, scheduling and reviewing work, ensuring quality standards. Is responsible for hiring, terminating, training and developing, reviewing performance and administering corrective action for staff (may be subject to final approval by leadership). Plans organizational structure, position content and staffing. Directly Supervises 6 - 10; Indirectly Supervises 4 - 6   Position Requirements Minimum Job Qualifications Education: MS Degree in Pharmaceutical Sciences, Chemical Engineering or related discipline is highly preferred. Experience: Ten (10) years of relevant work experience in pharmaceutical product development, and at least five (5) + years in oral controlled release product development; Five (5+) years prior supervisory management experience. Prior management role within a contract development and manufacturing organization (CDMO) is highly preferred. Knowledge/Skills/Abilities Working knowledge of GLP/cGMP regulations and safety procedures. Good working knowledge of MS Office (Word, Excel, PowerPoint, Access, and Outlook), Sigmaplot and JMP or equivalent and experience with the internet. Strong knowledge of common pharmaceutical raw materials, their applications, and the principles of formulation development. Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquires or complaints from regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to present information effectively to top management, public groups, and client companies. Ability to apply mathematical operations to such tasks as determination of test reliability and validity, statistical analysis including but not limited to frequency distribution, analysis of variance, correlation techniques, sampling theory, and factor analysis. Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables. 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 - The employee must regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include Close vision, Distance vision and Peripheral vision. While performing the duties of this Job, the employee is regularly required to stand and talk or hear. The employee is frequently required to use hands to finger, handle, or feel and reach with hands and arms. The employee is often required to walk or sit. 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, contractors, vendors 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 such as safety rules, operating and maintenance instructions, and procedure manuals; interpret technical and engineering data; generate technical reports of investigations; analyze and solve practical problems and deal with a variety of concrete variables; establish priorities and work on multiple assignments and projects concurrently. The employee is regularly required to apply computer skills covering word processing, spreadsheet, and presentation software. The employee is regularly required to apply mathematical formulae and engineering rules of thumb to tasks and execute technical and engineering calculations. Work Environment - 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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