Title: Director, Formulation Job Summary This position is responsible for developing generic pharmaceutical formulations and managing the product development process for ANDA products. Our Company Amerigen Pharmaceuticals Inc. is an emerging generic pharmaceutical company with its corporate office in New Jersey and an FDA approved finished dosage form manufacturing facility in Suzhou, China. At Amerigen, we are committed to develop and manufacture high quality generic pharmaceuticals. Employees are challenged to take initiative and achieve outstanding results. As an employee of Amerigen Pharmaceuticals, you will actively contribute to the development and commercialization of our products. Our global presence and small company culture provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the company’s success. Job Description Amerigen is currently seeking an experienced, talented and innovative Formulation Director to join our Product Development team located at our Suzhou, China site. As a Director you will report to the Senior VP of Product Development and the COO, China Operations. Responsibilities: Developing formulation strategies for selected generic products, taking into account technical, regulatory and intellectual property considerations. Ensuring timely completion of new product development projects, specifically developing formulations bioequivalent to the reference products; developing manufacturing processes for the ANDA registration batches; directing/managing all activities associated with the registration batch manufacturing; authoring, reviewing and approving technical documents (protocols, batch records, specifications, development reports, etc.). Interacting with Manufacturing, Validation, and Materials Management to assure smooth scale up of formulations to commercial scale. Advising Manufacturing and Quality Operations of possible impact that deviations from prescribed operating conditions or procedures may have on products. Developing, interpreting and explaining standard practice instructions and procedures, and ensuring that they are complied with. Managing, training, and developing scientific staff. Maintaining effective communication within areas of responsibility. Responsibility and authority for matters such as maintaining quality, accuracy and quantity of work; giving advice, guidance, and direction; dealing with routine problems; developing detailed internal work methods; initiating recommendations on personnel matters. Monitor and appraise the performance of personnel reporting to the position Overseeing and/or collaborating with external parties involved with formulation development and/or manufacturing. Qualifications A Science degree is required, preferably in Pharmaceutics or Chemistry. An advanced degree (PharmD, Masters, or PhD in a science related discipline) is strongly preferred. Minimum of 8-10 years of experience with pharmaceutical development programs, preferably with generic product development. Hands on experiences in developing and manufacturing solid oral dose product, especially modified release products. Solid understanding of cGMP. Excellent interpersonal, supervisory, investigative, and implementation skills. Must have desire to work and excel in a rapidly changing, small company environment where a “hands-on” approach is required. Must have strong leadership abilities. Requires the ability to influence others and communicate effectively, written and orally, both internally and externally. Must possess excellent written and verbal communication skills. Requires the ability to prepare and review technical reports Requires the ability to motivate, lead, and develop departmental staff from an organizational as well as technical perspective Demonstrated ability to work effectively in a team environment, manage multiple priorities, exercise sound judgment, be well organized, take initiative, be flexible, work well under pressure and produce accurate and timely work. Fluent in both Chinese and English. Contact: Please send your resume to email@example.com.