• Senior Scientist Pharmaceutical Development

    Location US-NJ-Bridgewater
    Posted Date 2 weeks ago(5/7/2018 5:54 PM)
    ID
    2018-2158
    Company
    Kashiv Pharma LLC.
  • Overview

    This new role has primary responsibility of 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 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.
    • Effectively utilize biopharmaceutical understanding in designing novel drug delivery and in-depth understanding of Quality by Design product development, FDA guidance and c-GMP compliance.
    • Support Production/Manufacturing Department to ensure smooth transfer of new products into production/ manufacturing facility.
    • Communicate and present development activities, findings and recommendations to 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.
    • Ensure completion of tasks on schedule. Maintain up-to-date records for all work performed and ensure a safe and productive workplace.
    • Perform other functions as required or assigned.
    • Comply with all company policies and standards 

    Qualifications

    • PhD. in Pharmaceutics, Chemistry, or related field is preferred with minimum 3 to 5 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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