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Associate Director, Analytical R&D

Company: Regional Recreation Corporation of Wood Buffalo
Location: Piscataway
Posted on: February 25, 2021

Job Description:

Associate Director, Analytical R&D in Piscataway, New Jersey - Careers at Kashiv BioSciences LLC. Skip Branding

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  • Contact We are a people-oriented organization. About Company Overview Leadership Business Development Facilities Research & Development Drug Delivery Technology Biosimilars Prodrugs Pipeline 505(b)(2) Biosimilars Prodrugs News Press Releases Presentations Careers Contact Us -- 2019 Kashiv BioSciences, Inc. All Rights Reserved. Terms of Use - Privacy Policy - Copyright Policy - Sitemap Associate Director, Analytical R&D in Piscataway, New Jersey - Careers at Kashiv BioSciences LLC. Skip to Main Content Please Enable Cookies to Continue Please enable cookies in your browser to experience all the personalized features of this site, including the ability to apply for a job. Welcome page Welcome page Returning Candidate? Log back in! Associate Director, Analytical R&D Location US-NJ-Piscataway Posted Date 1 month ago (11/3/2020 10:50 PM) ID 2020-2586 Company Kashiv BioSciences LLC. Overview Kashiv BioSciences is a fully-integrated biosciences company with an expanded and dynamic platform for growth including advanced drug delivery technologies, biosimilars, prodrugs, and a large development pipeline. We are looking for an experienced Associate Director to join our Analytical R&D team.-- The Associate Director will lead the Analytical Team focusing on developing new molecules, supporting Process Development activities, and maintaining good laboratory practices out of the Piscataway, NJ site. Travel to the Chicago, IL office may be required. Responsibilities
    • Act as scientific/technical expert within the function /department and lead the development of scientific strategies, execution of method development and validation, drug substance and drug product characterization, analytical similarity testing, release and stability testing, and submission documentation preparation
    • Analyze and interpret analytical data to support product development, investigations and regulatory submissions.
    • Plan detailed procedures for lot release, stability and product characterization testing, including timelines, milestones, methodological approaches, expected results, and necessary resources.
    • Keep current in analytical development field including literature and technology development for cutting edge and regulatory driven activities for Biosimilars.
    • Guide the successful completion of major programs by either functioning in a project leadership role or as the lead scientific/technical resource.
    • Provide guidance in the resolution of scientific/technical issues within the function/department. Integrate activities with other functions/departments.
    • Evaluate progress toward goals and achievement of milestones for work group and translates them into appropriate actions. Develop novel processes or approaches to solve problems within a broad disciplines.
    • Identify and analyze factors and trends outside immediate area that impact projects or function/department.
    • Coach, motivate and provides career and technical advice to direct reports
    • Communicates and/or presents scientific/technical information formally and informally within area of expertise to a diverse set of audiences, including senior management.
    • Champion new ideas and initiatives; bring out and utilize others' creativity to improve unit performance.
    • Establish effective and responsive relationship with third party CMO and CRO;
    • Performance management - ensures direct reports are adequately oriented and developed to perform at a high level; monitors performance and provides adequate feedback through coaching and effective performance appraisal and development planning.
    • Performs other functions as required or assigned
    • Complies with all company policies and standards Qualifications
      • Previous experience managing and developing a team of scientist.
      • Demonstrated advanced knowledge and experience in understanding concepts about the structure and function of protein therapeutics and methodologies (such as HPLC, SEC, CE-SDS, ELISA, Biacore SPR, cIEF, LC-MS, fluorescence spectrometry) employed to characterize the biophysical and biological activities of proteins
      • Demonstrated experience in designing and evaluating analytical product comparability/similarity of Biosimilars
      • Expertise in method development and validation and technology transfer
      • Experience with GMP, regulatory filings (IND, BLA, and NDA) and ICH Guidelines.
      • Ability to expand analytical development expertise to a broader level of understanding in biopharmaceutical R&D and commercialization.
      • Analytical technical expertise in protein biologics for Drug Substance and Drug Product as well as Pre-filed syringes. Education --- PhD in Biochemistry or Analytical Chemistry is preferred and 12+ years in biotechnology or pharmaceutical industry. Masters degree required. Options Apply for this job online Apply Share Refer this job to a friend Refer Sorry the Share function is not working properly at this moment. Please refresh the page and try again later. Share on your newsfeed Loading... Application FAQs Software Powered by iCIMS
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Keywords: Regional Recreation Corporation of Wood Buffalo, Trenton , Associate Director, Analytical R&D, Executive , Piscataway, New Jersey

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