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Generic Pharmaceuticals - Quality Control Chemist

Company: Chartwell Pharmaceuticals
Location: Congers
Posted on: February 24, 2021

Job Description:

DEAR CANDIDATES, please respect our position, experience, and location requirements before you apply to the position and we incur the cost. We will only consider candidates that meet all of the requirements, so please apply if you do. Thank you for your interest and understanding.
About Chartwell PharmaceuticalsChartwell Pharmaceuticals, LLC is a privately-held, US-based generic pharmaceutical manufacturer with manufacturing in Congers (Rockland County), New York, R&D Operations in Israel and API functions in Portugal. With over 150 ANDA listings in the FDA Orange Book, Chartwell is rapidly growing and transforming our business as a Contract Development and Manufacturing Organization to also include be a full-scale Generic Pharmaceutical Manufacturer and Distributor serving the Retail, State and Federal Government Markets under the "Chartwell Rx" labels. This is an excellent opportunity to get in on the ground-floor with a fast-growing and dynamic generic pharmaceutical company!
Position Summary
The Pharmaceutical Chemist independently conducts routine analytical testing to support multiple projects such as routine QC release of finished drug products, intermediates and excipients; stability programs; method development, validation/verification and transfer of analytical methods; and preparing protocols, executing, and documenting results.
Essential Duties & Responsibilities

  • Read and interpret analytical methodology and the USP.
  • Perform analytical testing of pharmaceutical products using appropriate analytical methodology.
  • Maintain accurate, detailed records of work performed using available data collection media.
  • Proficient at HPLC/GC analysis with minimum troubleshooting skills.
  • Ability to perform in-house calibration for lab instruments such as HPLC, UPLC and GC preferred.
  • Write laboratory reports and other interdepartmental correspondence.
  • Good analytical and problem-solving skills.
  • Perform method validation for methods such as cleaning, assay, dissolution, related compounds, or particle size as assigned.
  • Assist in ensuring testing is in adherence to schedules through team oriented process.
  • Ability to train new hires.
  • Follows Chartwell Pharmaceuticals' Safety, Health, and Environmental policies and procedures.
  • Performs other duties as assigned or as business needs require.
    Primary Outcomes
    • Work with team to meet production, validation, stability and request deadlines.
    • Pharmaceutical Drug Substance and Drug Products are accurately analyzed following analytical methodology, and USP requirements.
      Position Requirements
      • B.S. in Chemistry or related science with minimum five years of related bench-top laboratory experience.
      • Masters in Chemistry desirable.
        Specialized or Technical Knowledge:
        • Background in Analytical Chemistry with emphasis on routine testing and method development and validation preferably in a regulated industry.
        • Strong practical knowledge of Chromatography, Spectroscopy, Particle Size Distribution and wet chemistry.
          • Experience in a Pharmaceutical Laboratory in a Commercial firm is a must.
          • Excellent computer skills including MS Office.
          • Excellent organization skills and attention to detail, self-driven, and motivated.
          • Excellent at handling multiple projects at one time, and changing priorities based on business needs.
          • Excellent interpersonal, oral, and written communication skills.
          • Able to work effectively independently and as part of a team.
          • Perform routine analysis of raw materials and finished product.
          • Able to work overtime, including weekends, when required.
          • Able to safely handle chemical and hazardous materials and may be required at times to wear Personal Protective Equipment.
            PLEASE NOTE: ---
            • This position is based in Congers, NY with candidates from the New York Metropolitan area only.
            • Sponsorship is not available for this position.
            • Agency referrals are not accepted.

Keywords: Chartwell Pharmaceuticals, Yonkers , Generic Pharmaceuticals - Quality Control Chemist, Healthcare , Congers, New York

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