Location: Buena, NJ
The Product Development Manager will lead the Buena Product Development Teams through all aspects of the design and development of generic drug products. This individual will have responsibility for ensuring that all aspects of formulation, process and analytical development/validation are completed to the highest standards in a timely manner. The individual will serve as the VP R&D’s primary contact for managing project deliverables, resolving technical issues and related to product development.
Provide leadership to 3-5 direct reports
- Responsible for the Product Development scientific and technical standards, critical review of documentation and reports, and setting strategy to support product development. Ensure high quality of all aspects of product and analytical method development in a GMP environment.
- Manage multiple projects for new product development and marketed product support throughout the product lifecycle in line with agreed timelines.
- Generate and compile documents for ANDA submissions and response to deficiency letters from FDA.
- Oversee the design and initiate development of formulation, process and analytical methods to support all stages of drug development from drug substance characterization through formulations and process development and ANDA submission of injectable products.
- Establish an effective department infrastructure and systems to enable product development, and transfer by leveraging internal and external expertise and capabilities.
- Critically evaluate and interpret experimental data for conclusions and resolution of problems. Provide suggestions and problem resolution based on technical expertise.
- Compile, maintain, review and interpret product development data.
- Develop and maintain efficient and a compliant Product Development Laboratory
- Ensure collaborative working relationships with other functional groups to ensure consistency and suitability throughout the drug development process.
- Allocate resources to achieve project deadlines.
- Report on progress, success, and failure of projects.
- M.S. or PhD in Organic or Analytical Chemistry, Pharmaceutical Sciences or related discipline.
- A minimum of 10 years of experience from pharmaceutical industry or R/D management positions from sterile injectable and or Topical product development.
- Proven ability to apply advanced chemical science principles, theories, concepts to a broad range of research problems and develop innovative solutions for problems related to drug substances and drug products.
- Excellent written and oral communications, project management and team leadership experience from pharmaceutical or other fields.
- While performing the duties of this job, the employee is regularly required to stand. The employee is frequently required to walk; sit; use hands; talk; and hear. The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.