• Senior Director Pharmaceutical Development

    Location US-NJ-Bridgewater
    Posted Date 2 weeks ago(5/7/2018 2:06 PM)
    ID
    2018-2154
    Company
    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.

    Responsibilities

    • 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 

    Qualifications

    • 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.

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed