• Senior Director Pharmaceutical Development

    Location US-NJ-Bridgewater
    Posted Date 4 weeks ago(5/25/2018 1:56 PM)
    Kashiv Pharma LLC.
  • Overview

    This new role has primary responsibility of providing scientific leadership in developing complex injectable products leading to successful ANDA/NDA filings and approval for GENERICS and 505B2 products. The candidate will be responsible for timely development of products through internal development and through our partners.


    • Responsible to provide guidance for all aspects of formulation/process development, scale-up manufacture submission/registration batches with efficient utilization of time/resources and proven successful tracking records.
    • Serves as subject matter resident expert in formulation development, process optimization of innovative injectable products for small molecules/peptides/proteins.
    • Supervises and mentor scientists in developing innovative, complex injectable formulations by effectively utilizing biopharmaceutical understanding in designing novel drug delivery and in-depth understanding of Quality by Design product development, FDA guidance and c-GMP compliance.
    • Supports Production/Manufacturing Department to ensure smooth transfer of new products into production/ manufacturing facility.
    • Manages internal/external projects independently within team environment
    • Communicates and presents development activities, findings and recommendations to the management.
    • Responsible for providing high quality ANDA/NDA documentation of product development with overall broad knowledge on regulatory aspects in a fast paced team environment.
    • Establish “Critical Quality Attributes” for the injectable drug products and ensure their consistencies from laboratory to scale-up/submission batches and commercial batches.
    • Review and approve all laboratory investigations, and support FDA audits as needed.
    • Identify, qualify and work with CMOs (Contract Manufacturing Organizations) for sterile clinical supply manufacturing.


    • Support recruitment, plan work for team and ensure completion of tasks on schedule.Maintain up-to-date records for all work performed and ensure a safe and productive workplace.
    • Performs other functions as required or assigned.
    • Complies with all company policies and standards 


    • PhD. in Pharmaceutics, Chemistry, and Bio/Chemical Engineering or related is preferred with minimum 15 years in the development of small molecules/peptides/proteins for GENERICS and 505b2 injectable products.
    • Thorough knowledge of characterization of peptide/protein complex formulations with demonstrated success with emerging technologies and proprietary formulation approaches.
    • Expertise in complex injectable products including nano-particulate based systems and liposome formulations desired.
    • Knowledge of protein and peptide stability in aqueous as well as lyophilized product is necessary
    • Proficient in the interpretation of and contribution to patents
    • Ability to interface with cross-functional teams with a high degree of flexibility
    • Goal-oriented, attention to detail, proven ability to complete projects on time and within budget
    • Exceptional people management and leadership skills
    • Strong communication (oral and written) communication and organizational skills
    • A forward thinking, proactive person who can draw on past experience to make balanced and pragmatic decisions.


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