• Lab Technician, Upstream Process Development

    Location US-NJ-Bridgewater
    Posted Date 3 weeks ago(11/20/2018 12:39 PM)
    ID
    2018-2190
    Company
    Kashiv Pharma LLC
  • Overview

    Kashiv Pharma, LLC is an emerging pharmaceutical research and drug delivery company focused on developing innovative technologies, improved medicines and life cycle management products. Kashiv also offers contract research and development services to pharmaceutical clients in need of formulation and analytical development expertise and/or clinical supply manufacture.

     

    Our vision is to make biosimilar medications affordable. We are seeking candidates interested in contributing to a bourgeoning field that has the potential to help millions of patients. As a growing company, Kashiv Pharma offers real development opportunities for candidates excited to take on responsibility, make an immediate impact and help us achieve our vision. As part of a close knit team, you’ll have the opportunity to work in a unique, high science industry while expanding your career.    We are seeking a temporary to perm Lab Technician, Upstream Process Development, to be based out of our offices in Bridgewater, NJ.

     

    In this role, you will assist with acitivites related to performing routine Fermentation and Cell Culture operations, Tech. transfer, and trouble shooting for the production of clinical and/or commercial products. 

     

    Responsibilities

    Assist with the following:

      • Operate production equipment according to SOPs.
      • Tech transfer and manufacturing activities of full scope, including but not limited to work

      functions in Cell Culture, Solution & Equipment Prep areas.

      • Will be required to write and edit SOPs, and maintain production equipment.
      • Maintain records and clean room environment to comply with regulatory requirements, GMPs,

      and SOPs.

      • May assist with the execution of validation protocols and studies.
      • May assist with in-process testing to assure batches meet specifications.
      • Incumbent will be required to make process decisions, with the help of supervision, including the

      trouble shooting of equipment, corrective action to process deviations.

      • Individual will be required to understand operations and contact appropriate support to ensure

      issues are appropriately resolved.

      • Will be required to identify process deviations and with guidance take immediate action to

      mitigate event.

      • Ensure that all projects are executed properly, attaining desired outcomes on schedule and

      meeting quality standards.

      • Support equipment installation, qualification and cleaning validation.

    Qualifications

    • Bachelor's or Masters degree in Biochemistry or related scientific displine.  
      • Minimum 6 month relevant lab experience (e.g. working with cell culture and asceptic techniques) strongly preferred 
    • Excellent verbal, written and organizational skills.

     

    SPECIALIZED KNOWLEDGE AND SKILLS:

    Language:

    • Must read, write, and speak English fluently.

    Reasoning Skills:

    • The ideal candidates will be self-motivated and be able to function in a fast-paced environment, multi-task, and handle multiple responsibilities.
    • Ability to work with minimal supervision, within prescribed guidelines, or as a team member and the demonstrated ability to follow detailed directions.
    • Candidates must be able to generate detailed written records of the work accomplished in a timely manner.

    Computer and/or Technical Skills:

    • Skilled in word processing, spreadsheets, and data management.
    • Detail oriented with strong written and verbal communication skills.

     

    WORK ENVIRONMENT AND PHYSICAL DEMANDS:

    General Work Environment:

    • Process Development/Manufacturing

    Noise:

    • Standard noise levels in process development lab/manufacturing

    Standing/Lifting:

    • Extended periods of standing and walking while working in the development areas.
    • Must be able to lift up to 30 lbs.

    Visual:

    • No special requirements.

    Stress:

    • High paced demanding environment to meet the needs of the company.

    Travel:

    • Minimal travel will be expected, but not to exceed 10%.

    Kashiv Pharma embraces equal employment practices, including: refraining from discriminating on the basis of race, color, religion, sex, national origin, disability, or protected Veteran status

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