Job: Director, Product Development, China Market Products

Title Director, Product Development, China Market Products
Categories Product Development
Location Whilst the position is intended to be U.S. based, either in New Jersey or a home office elsewhere, considerable travel to China, including for extended periods, is envisaged. Alternately, for the right candidate, the Company could consider the position actually be based in the Shanghai/Suzhou area of China.

Job Summary
This position is responsible for providing technical oversight and to manage the product development process for Amerigen products intended to be filed in China.

Our Company
Amerigen Pharmaceuticals Inc. is a rapidly growing generic pharmaceutical company with its Corporate Headquarters in New Jersey and a U.S. FDA / CFDA approved finished dosage form manufacturing facility in Suzhou, China. The Company is privately owned and led by a highly experienced management team.

At Amerigen, we are committed to the development, manufacture and sale of high quality generic pharmaceuticals with a focus on complex oral solid dosages and first-to-file/first-to-market generics. Our primary focus is on the U.S. market, with a secondary emphasis on China, building off our local presence in Suzhou. The Company currently has approved generic pharmaceutical products on sale in both the U.S. and China.

Employees are challenged to take the initiative and achieve outstanding results. As a key member of the Amerigen Pharmaceuticals team, you will actively contribute to the development and commercialization of our products. Our small company culture provides an exciting opportunity to make a meaningful contribution to the evolution of the business and interact across the full range of functionalities.

Job Description
Amerigen is currently seeking an experienced, talented and innovative Product Development Director to join our Product Development team. As a Director you will report to the Senior VP of Product Development.

The primary purpose of the role is to lead the product development process in support of the registration of Amerigen’s U.S. ANDA products (or for international products for which Amerigen has secured local rights) in China. However, from time to time, it may be necessary to develop products specifically for the China market and this will be an additional purpose of the role.

Amerigen’s strategy for registration and commercialization of products in China varies depending on the specifics of each product. Options include (i) licensing out to a local partner who would take the lead in product development and registration activities after a tech transfer; (ii) import registration of international products in China either by Amerigen or a local partner; (iii) co-development of products with a local partner with responsibilities shared between the parties; and (iv) self-development and registration by Amerigen. In all these cases the Director of Product Development, China, would be the operational owner of the project from an Amerigen perspective, responsible for driving it to a successful conclusion.

Specific Responsibilities
  • Working with Business Development to identify attractive product candidates for the China market.
  • Developing product development strategies for selected Amerigen products in China, taking into account technical, regulatory and intellectual property considerations.
  • Interacting with various internal and external sites/parties to ensure timely completion of new product development projects, specifically providing technical oversight on formulation approaches, analytical method development and manufacturing process development, directing/managing all activities associated with the registration batch manufacturing; reviewing and approving technical documents (protocols, batch records, specifications, development reports, etc.).
  • Interacting with Manufacturing, Validation, and Materials Management to assure smooth technology transfer, scale-up of formulations to commercial scale.
  • Interacting with regulatory professionals to ensure CFDA requirements are met during product development to ensure smooth registration in China.
  • Overseeing and/or collaborating with external parties involved with formulation development and/or manufacturing.
Desired Skills & Experience
  • 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 10 years’ experience with pharmaceutical development, preferably including some generic product development.
  • Familiarity with international pharmaceutical regulations, especially U.S. FDA regulations.
  • Familiarity with CFDA regulations would be helpful but is not critical as additional resources would be available to provide support in this area. A desire to learn CFDA regulations is, however, important.
  • Hands on experiences in developing and manufacturing solid oral dose products, especially modified release products.
  • Familiarity with the ICH requirements for analytical method development and method validation.
  • 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 with a forceful drive for goals balanced by the need to foster and maintain collaborative relationships within the Company and its partners.
  • 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.
  • Must be fluent in both English and Mandarin Chinese (written and oral).
  • 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.
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