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R&D Site Director

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Title:  R&D Site Director
Position Type: Full-time
FLSA Status: Exempt
Department: Research and Development
Report To: Deputing Head of Global R&D
Effective Date: Immediately

Location:                    Piscataway, New Jersey, USA


We are seeking a talented R&D Site Director to manage our R&D center in New Jersey facility, located in Piscataway, NJ.  This R&D Site Director will lead a team of formulation scientists, analytical scientists and other technical professionals with responsibility for developing generic, specialty pharmaceutical products. This includes leading the projects to support a consistent flow of ANDA and NDA filings and ensuring timely responses to questions raised by the FDA. This position will have the responsibility for overseeing the overall R&D activities in this site, building key technical and leadership capabilities within the team and maintaining a productive, diverse, and engaged workforce. Additionally, this position will support R&D activities in other PuraCap R&D centers globally on a need base. This R&D Site Director will report to the Head of PuraCap Global R&D.

B.  Responsibilities

Set strategic direction, determine goals/objectives/priorities for multi-disciplinary team of scientists with responsibility for product formulation, method development, method validation, stability testing, R&D tech transfer, FDA deficiency response and technical filings to ensure delivery of company goals
Ensure constant flow of ANDA and NDA filings, in support of company goals for new project launches, through oversight of project timelines
Overall team leadership including: setting individual/team goal, ensuring employee development, providing on-going coaching and feedback, recognizing employees for their contributions, enabling meaningful career experiences and creating an inclusive and safe work environment
Audit and review procedures, processes, data and laboratory preparedness for inspections. Participate in FDA and internal audits, take leadership role in preparation of documents that clearly address key issues raised during audits and execute any changes to process, as needed
Writes reports, initiates and reviews documentation and guides others in these efforts, particularly for regulatory filings
Ensure timely submission of deficiency responses
Ensure all work is completed within cGMP, SOP, FDA, ICH guidelines, including ensuring staff is fully trained in all requirements
Provide technical direction and guidance to the team in response to FDA deficiency letters and ensure timely deliverables
Participate as a member of cross-functional teams, as needed, including partnership with Regulatory, R&D, Manufacturing, Procurement, etc., to ensure achievement of company goals
Ability to partner cross-functionally and work on cross-functional teams (QA/QC, Regulatory, Manufacturing, Procurement, etc.)
Project management skills and understanding of prioritization aspects including ability to anticipate and manage internal and external resource needs (people, information, technologies, time, and capital)

C.  Qualifications

  • Ph.D. degree in Chemistry or Life Sciences from an accredited university
  • 10+ years of experience in the area of pharmaceutical product development
  • Thorough knowledge of solid oral dosage forms is required, including understanding of production, PK/bioequivalent studies and regulatory requirements
  • 5+ years supervisory experience of multi-disciplinary R&D organization
  • Excellent oral and written communication, collaboration and multitasking skills and ability to work in a team setting
  • Work authorizations in US


PuraCap Pharmaceutical LLC is an equal opportunity employer and affords equal opportunity to all applicants and employees for all positions without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other status protected under local, state, or federal laws.


If interested in applying for any of the above positions at PuraCap, please send your Resume / CV to humanresources@puracap.com